this information to additional personnel within their facility as appropriate and return the questionnaire to Medtronic.. Customers with questions should contact their Medtronic Sales Representative at 800-876-3133, extension 3197. Home 3 GraftonDBF Inject has higher OI than all competitors tested* OSTEOINDUCTIVITY BY PRODUCT* This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Spinal & Orthopaedic Global Unique Device ID: 00643169123151. We also offer a .
Caution should be exercised if the patient is allergic to these antibiotics or chemicals.
Home Grafton DBM has been used in over 1.5 million surgeries.
And a fiber technology proven to be osteoconductive in a preclinical outcomes study.
: : jp2015137638: : 2015-07-09: (): jp2015221221a Grafton DBF Inject can be used in orthopaedic or reconstructive bone grafting procedures. 2 10/18/2012 Osteotech Inc Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralize 1999;24(7):637-645. Grafton, 1cc Putty (43102) Item # : GR-PT1. Update my browser now. Version (Model) Number: A43205. Device Identifier (DI) Information. Less information (see less), Learn more about how Grafton DBF Inject can improve your workflow and operating room (OR) efficiencies (4:48).
and anterior lumbar interbody fusion (ALIF) procedures at a single level (Medtronic, 2018).
The presence of infection at the transplantation site. Medtronic Sofamor Danek USA, Inc. Acrobat . We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. Grafton DBM has over 25 years of clinical history. Background Comminuted femoral fractures pose a challenge to the trauma surgeon due to the absence of bony references during surgery.
Common Uses: Spine, Trauma, Pelvis, Extremities.
pdf New Jersey Drug and Medical Device Registration (.pdf) 24KB. Home Histology scoring based on Edwards JT, Diegmann MH, Scarborough NL. Available in two distinct formulations, Grafton Orthoblend combines demineralized bone fibers with cancellous chips or crushed cancellous chips. After Grafton DBM is implanted, cells migrate into the allograft material and remodel it into new bone. Biosurgery - Medtronic - eSutures - The Suture Superstore For questions regarding this recall call 732-542-2800. Find coding and reimbursement resources for physicians and hospitals from Medtronic SpineLine.. Scarborough N, White E, Hughes J, Manrique A, Poser J. Allograft Safety: Viral Inactivation with Bone Demineralization. Dental Bone Grafting Company Name: MEDTRONIC SOFAMOR DANEK, INC.. If your locale is not listed, please contact your Medtronic sales representative or your local Medtronic office for technical support on Medtronic products.
QUICK VIEW. Spinal & Orthopaedic Manufacturer Parent Company (2017) Medtronic plc. Bacterial infection at the graft site may also occur. Bone Grafting Grafton Putty consists of demineralized bone fibers and can be mixed with either allograft or autograft bone.
Any adverse outcomes potentially attributable to GRAFTON DBM or GRAFTON PLUS DBM must be reported promptly to Medtronic. This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions.
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Medtronic said that the Grafton DBM is comprised of multiple forms, and that it is launching the Grafton Putty, Grafton Matrix and Grafton Strip in Japan. GRAFTON PLUS DBM Paste contains starch. - (04:53).
Animal testing is not necessarily indicative of human clinical outcomes. 2005; 13(2):129-137. This is a preview of the recently viewed products by the user. Bacterin International osteoselect dbm putty Osteoselect Dbm Putty, supplied by Bacterin International, used in various techniques .
Based on internal testing in an athymic rat model. MEDTRONIC SOFAMOR DANEK, INC. Company name associated with the labeler DUNS Number entered in the . Grafton DBF Inject is an injectable . Issuing Agency: GS1. Registre des essais cliniques.
Allograft bone is well documented in clinical studies and has an excellent safety record.
The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Proposed Proprietary Trade Name: MASTERGRAFT Putty Grafton DBM Indications, Safety, and Warnings, Grafton DBM Indications, Safety, and Warnings. With an updated browser, you will have a better Medtronic website experience. Grafton Dbm Putty Osteotech, Inc. is a global leader in the processing of human bone and connective tissue for transplantation and an innovator in the development, manufacturing and marketing of biologic, biomaterial and device systems for musculoskeletal surgery.
fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements. Bacterial infection at the graft site may also occur. SM Chip Size: 0.1mm4mm. Grafton DBF Inject and its patented* fiber technology enables the first flowable carrier free Fiber DBM on the market today. With the proprietary D-MIN process, Grafton consistently scores high osteoinductivity*, which is an important part of bone fusion. Medtronic's processing facility, located in Eatontown, New Jersey, is accredited by the American Association of Tissue Banks (AATB), and is committed to providing quality and innovation in its various demineralized bone matrix tissue forms. Therefore, caution should be exercised in using Grafton Plus DBM Paste in a patient with a starch allergy and/or amylase deficiency. Grafton DBM is the first ever demineralized bone matrix product available in Japan, which is the world's second largest Medtronic was the first to market with a fiber based DBM.
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We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you.
The Smartstorage System is an RFID-based, near real-time tissue tracking system that streamlines inventory management.
Medtronic Sofamor Danek PROGENIX Plus 510(k) Summary .
Please select the locale. GRAFTON DEMINERALIZED BONE MATRIX DENTAL BONE GRAFTING GraftonTM Demineralized Bone Matrix (DBM) is an allograft tissue, which means it is from a human donor, and thoroughly tested and processed to ensure safety and sterility. J Am Acad Surg. This allograft may contain trace amounts of antibiotics (gentamicin) and processing solutions. Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Instructions for use and product manuals for healthcare professionals. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of the skeletal system (ie spine, pelvis and extremeties) not intrinsic to the stability of the bony structure. The proprietary demineralization process inactivates viruses while preserving the osteoinductive activity necessary for new bone formation. Allograft bone is well documented in clinical studies and has an excellent safety record. Learn more about how Grafton DBF Inject can improve your workflow and operating room (OR) efficiencies (4:48).
By eliminating the need for a bone funnel and tamp, Grafton DBF inject has the potential to reduce the number of steps needed to deliver bone graft and improve OR efficiencies. See how easy it is to hydrate and deliver Grafton DBF Inject into the disc space for open and MIS spinal procedures (3:27). Medtronic plc MDT recently announced the launch of the Grafton demineralized bone matrix (DBM) bone grafting product in Japan. DOTmed.com is a medical and hospital equipment classified advertising site for new and used medical equipment for sale or wanted, we also list refurbished medical equipment. Over-pressurize the delivery device, as this may lead to extrusion of the device beyond the site of its intended application and damage to the surrounding tissues. GRAFTON DBM DBF can be used in orthopedic or reconstructive bone grafting procedures. Once the user has seen at least one product this snippet will be visible.
Bone Grafting Spine 2012;37:1083-91.
Osteotech Inc, 51 James Way, Eatontown NJ 07724-2272. Update my browser now. Spinal & Orthopaedic
Grafton Paste is moldable and can be mixed with allograft or autograft bone. Version (Model) Number: T43105. 1995 Oct; 31(4): 257-61.
Common Uses: Spine, trauma, pelvis, extremities. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V.
Minimally invasive multilevel percutaneous correction and fusion for adult lumbar degenerative scoliosis: a technique and feasibility study.
Do not use the contents of any container for multiple patients. Bone Grafting Contraindicated for use in the presence of infection at the transplant site. Use this form to request a sample.
Register to receive a free U.S. Market Report Suite for Orthopedic Biomaterials report synopsis and brochure Medtronic announced the launch of the Grafton Demineralized Bone Matrix (DBM) for spine and orthopedic procedures on February 28th, 2019. Memphis, TN 38132 www.medtronic.com. (Available bone harvested from your body may be limited.). Medtronic conducted an extensive study assessing the impact of age and gender on osteoinductivity. Home
Grafton DBF Inject. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you.
Appl Biomater 70B:21-29, 2004. With a particular focus on spinal, trauma, and total joint revision procedures .
GRAFTON DBM and GRAFTON PLUS DBM are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Contemp Orthop.
. Catalog Number: Company Name: MEDTRONIC SOFAMOR DANEK, INC. Primary DI Number: 00643169123144. Commercial Distribution Status: Not in Commercial Distribution.
Two grafts per package. A proven osteoinductive DBM and delivery solution all in one Grafton DBF Inject combines the highest Osteoinductive DBM when compared to competitors with a unique graft delivery syringe that can deliver graft material directly into the surgical site. Grafton DBM demineralized bone fibers (DBF) can be used in orthopedic or reconstructive bone grafting procedures. GRAFTON PLUS DBM Paste (Osteotech, K040348, SE 11/23/05) and OSTEOFIL DBM Paste (Regeneration Technologies, Inc., K043420, SE 01/10/05). Manufacturer Grafton DBM is the most utilized DBM brand available.
- (03:27), More information (see more)
GRAFTON DBM (excluding the Orthoblend form) and GRAFTON PLUS DBM are also intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral, and cranio-/maxillofacial defects.
*Third party brands are trademarks of their respective owners.
: DEPARTMENT OFHEALTH &HUMAN SERVICES Public Health Service . Insufficient numbers of 76-85-year-old females resulted in exclusion from analysis. . Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. GRAFTON PLUS DBM Paste contains starch. No more worrying about manual recordkeeping the Smartstorage System keeps accurate usage history and temperature logs. Grafton Flex is a flexible sheet that can be applied whole, or cut into strips or smaller pieces.
Device Name: DBM A43205 0.5CC GRAFTON PUTTY SYRINGE. Preparation of the bone graft bed is important for graft incorporation and bone formation, as are other factors such as blood supply, source of marrow elements, loading, stability, and absence of infection at the graft site. Brand Name: GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM).
With an updated browser, you will have a better Medtronic website experience. VI. Photo: Courtesy of Medtronic.
The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft.
Grafton DBF Inject is a precisely controlled bone graft delivery system that enables pre- and post-packing of graft material in the interbody space through integrated cannulas. Units in stock: 5 . The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Medtronic grafton dbm Grafton Dbm, supplied by Medtronic, used in various techniques. The product can also be used in bone grafting procedures in combination with autologous bone or other forms of allograft bone, or alone as a bone graft. Process variables include: At Medtronic, we use our proprietary D-Min process to demineralize the allograft tissue that goes into the different Grafton DBM forms. Grafton DBM products, Magnifuse Bone Graft, Xpanse Bone Insert, Mastergraft Matrix ongoing final product testing (2006-2014); Accell Connexus , three manufacturing lots tested on 2005; Accell Evo3 c, three manufacturing lots tested on 2010/2014; Intergro Putty, one manufacturing lot tested on 2004; Accell Treatment of spinal insufficiency fractures.
Grafton DBM is a bone graft extender, bone graft substitute, and bone void filler in bony voids or gaps of the skeletal system (i.e., spine, pelvis, and extremities). Manufacturer Update my browser now. We are a liquidator of sutures (and other surgical items) from Medtronic/Covidien, Stryker, Arthrex - and many more - and are able to pass our savings on to you. Grafton DBF Inject is a precisely controlled bone graft delivery system that enables pre- and post-packing of graft material in the interbody space through integrated cannulas. Treatment of spinal insufficiency fractures. Global Unique Device ID: 00643169068636. Products Therefore, caution should be exercised in using GRAFTON PLUS DBM Paste in a patient with a starch allergy and/or amylase deficiency. The following are contraindications for the use of GRAFTON DBM and GRAFTON PLUS DBM: This allograft may contain trace amounts of antibiotics (gentamicin), surfactant, and other processing solutions. Grafton Putty (Medtronic) Test Article Lot # Average OI Score Group Std Dev Grafton Putty: TA IA OTSCT0709144036 Tissue Bank A 0.5 0.5 Grafton Putty: TA IB OTSCT0704164035 Tissue Bank A 0.43 0.53 Grafton Putty: TA IC OTSLN0832304037 Tissue Bank B 0.63 1.06 Table 2: Grafton Putty Osteoinductivity Scores. Issuing Agency: GS1.
ZERO BIAS - scores, article reviews, protocol conditions and more .
Our unique syringe design allows for seamless hydration and delivery of our premium, Grafton DBF bone graft.
Our bone graft options span osteoinduction, cell promotion, and cell enhancements to cell delivery, resulting in fusion success.
equivalent to previously cleared bone void fillers such as PROGENIX DBM Putty (Medtronic Sofamor Danek, K072265, SE 01/09/08)and GRAFTON DBM Crunch (Osteotech, Inc., K051195, SE 12/16/05). An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The voids or gaps may be surgically created defects or effects created by traumatic injury to the bone.
Products $21.00 EACH. Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic S. 2 02/12/2014 . Despite the viral inactivation and extensive tissue donor selection and qualification processes used in providing this tissue graft, transmission of an infectious disease through the use of this tissue graft is still possible. Grafton demineralized bone matrix (DBM) is the most utilized and scientifically studied DBM brand. Proven in published, peer-reviewed clinical studies, the success of Grafton DBM in multiple forms gives clinicians options for bone grafting applications. The volume of graft material used in each procedure is determined by the judgment of the clinician. . Grafton Gel can be injected percutaneously and can be mixed with cancellous chips. DBM involves removing 40% of the mineral content of the allograft and all the cells [48] [49] [50].. Spine. Extensive donor blood serum testing, medical and social history screening procedures, and tissue microbiological testing have been used in the qualification of all tissue donors. Any adverse outcomes potentially attributable to GRAFTON DBM DBF must be reported promptly to Medtronic. Your doctor may use these products alone or in combination with other grafting materials.
eSutures sells discounted, brand name sutures, suture material and endomechanicals.
It can be used with certain Medtronic interbody devices, when hydrated with bone marrow aspirate (BMA) for spinal and orthopedic procedures. Grafton DBF is regulated as a Human Cellular Tissue Product solely under 21 CFR, part 1271 so a 510K is not required. The following are contraindications for the use of GRAFTON DBM and GRAFTON PLUS DBM: Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. (2004) conducted a prospective equivalency trial of Grafton DBM and iliac crest autograft in spine fusion, with each patient serving . Grafton Matrix has a unique trough-like design that allows for use with allograft/autograft bone. Issuing Agency: GS1. Manufacturer Address. Update my browser now. .. .. . Download to view a summary of preclinical evidence for bone formation with Grafton DBF Inject. In August 2018, Medtronic secured approval from Pharmaceuticals and Medical Devices Agency (PDMA) for Grafton DBM, which is claimed to be the first and only demineralized bone matrix product available in Japan.
AccessGUDID - GRAFTON DBM (00643169134560)- DBM T43103INT 2.5CC GRAFTON PUTTY. Interested in trying it? Donors were grouped in the age ranges specified. GRAFTON DBM and GRAFTON PLUS DBM may be used alone in a manner comparable to autogenous bone chips or allograft bone particulate (demineralized freeze dried bone), or they may be mixed with either allograft or autograft bone or bone marrow as a bone graft extender.
Allograft Tissue Resource Center | Medtronic . Grafton DBF Inject outperforms competitors in the areas of delivery, hydration, fibers, and sterilization.
Medtronic - eSutures - The Suture Superstore
GRAFTON DBM is substantially equivalent, for the purpose of this 510(k), to other devices that have received 510(k) clearance for similar indications for use. NuVasive Propel DBM putty- no specific code: . Miscellaneous - Medtronic - eSutures - The Suture Superstore Fill out a quick form and we'll send you a Grafton DBF Inject sample. With an updated browser, you will have a better Medtronic website experience. From the Medtronic library by searching for the product name, Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Company: Medtronic Sofamor Danek USA, Inc. . Find bone grafting education and training resources from Medtronic.
Interested in trying Grafton DBF Inject? Therefore, caution should be exercised in using GRAFTON PLUS DBM Paste in a patient with a starch allergy and/or amylase deficiency. 15-23 One of the first articles evaluating the use of DBM in instrumented posterolateral fusion was a level III study by Sassard et al 15 that compared the use of DBM (Grafton Gel) and LA with iliac crest bone grafting (ICBG) in 1, 2 . Treatments & Therapies Grafton DBM is a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of .
Description. Spinal & Orthopaedic
QUICK VIEW. Spine.
Traianedes K, Russell JL, Edwards JT, Stubbs HA, Shanahan IR, Knaack D. Donor Age and Gender Effects on Osteoinductivity of Demineralized Bone Matrix.
"If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal . Device Identifier (DI) Information.
GraftonTM Demineralized Bone Matrix (DBM) is an allograft tissue, which means it is from a human donor, and thoroughly tested and processed to ensure safety and sterility. Caution: GRAFTON DBM DBF is restricted to use by a physician, podiatrist, or dentist. Grafton TM Demineralized Bone Matrix (DBM) is an allograft tissue, which means it is from a human donor, and thoroughly tested and processed to ensure safety and sterility. What Is It 2658-01-0002.
Product processing consistency is confirmed via ongoing testing.. Add to compare list. Yesterday, Medtronic said that it won 510 .
GRAFTON DBM (excluding the Orthoblend form) and GRAFTON PLUS DBM are also intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral, and cranio-/maxillofacial defects. Grafton DBF inject is the first pre-loaded targeted bone graft delivery system thatcombines a highly osteoinductive1 DBM with a unique fiber technology and graft delivery syringe that can be injected into the surgical site.
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