Data / Medical devices / United States / Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics: FDA-registered device maker in Edison, NJ, United States, 7 510(k) clearances
Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics is registered with the FDA (registration 2249062) in Edison, NJ, United States. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 15, 2019. 8 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2249062
- FEI number
- 3001236616
- Address
- 125 May ST, Ste 300 Edison Corp CTR, Edison, NJ, United States, 08837
- Owner or operator
- MUSCULOSKELETAL TRANSPLANT FOUNDATION (9032400)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 16, 2013
- Registered through
- 2026
- Brand names listed
- ACT Kit, AFT, BD Single Use Syringe, DBX Dental, DBX Inject, DBX Mix, DBX Paste, DBX Putty and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Human Source | NUN | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
| Instruments Designed For Press-Fit Osteochondral Implants | QBO | 2 | Repackager or relabeler | accessdata.fda.gov |
| Lipoaspirate Washing System For Aesthetic Body Contouring | QKL | 2 | Manufacturer | accessdata.fda.gov |
| Methyl Methacrylate For Cranioplasty | GXP | 2 | Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 15, 2019 | K181633 | MTF Pre-Sutured Tendon | GAT | Substantially Equivalent | Musculoskeletal Transplant Foundation | accessdata.fda.gov |
| May 13, 2011 | K110771 | BD SINGLE USE, HYPODERMIC SYRINGE | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| June 9, 2010 | K100754 | GRAFT DELIVERY SYSTEM MODEL SA-6115 | FMF | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
| September 28, 2009 | K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | Musculoskeletal Transplant Foundation | accessdata.fda.gov |
| July 28, 2005 | K042125 | AFT | MQV | Substantially Equivalent | Musculoskeletal Transplant Foundation | accessdata.fda.gov |
| April 29, 2005 | K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | NUN | Substantially Equivalent | Musculoskeletal Transplant Foundation | accessdata.fda.gov |
| March 17, 2005 | K040262 | DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX | MQV | Substantially Equivalent | Musculoskeletal Transplant Foundation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 22, 2023 | 93853 | Class II | Ongoing | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. | accessdata.fda.gov |
| September 22, 2023 | 93296 | Class II | Ongoing | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100 | Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery. | accessdata.fda.gov |
| March 29, 2021 | 87677 | Class II | Terminated | AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Num | 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery | accessdata.fda.gov |
| August 15, 2019 | 83644 | Class II | Terminated | QuickGraft Model # 430PST | Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure. | accessdata.fda.gov |
| April 21, 2016 | 74263 | Class II | Terminated | Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, p | AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field. | accessdata.fda.gov |
| May 27, 2015 | 71564 | Class II | Terminated | Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. | Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin. | accessdata.fda.gov |
| May 27, 2015 | 71559 | Class II | Terminated | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. | Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill. | accessdata.fda.gov |
| December 4, 2014 | 70739 | Class II | Terminated | DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler. | The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact. | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Syringe, Piston
- All makers of Instruments Designed For Press-Fit Osteochondral Implants
Updated February 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.