Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Jessup, PA, US
Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics appears in FDA device records in Jessup, PA. FDA records list 24 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Musculoskeletal Transplant Foundation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics between 2004 and 2019. The busiest year on record is 2006, with 5. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 3 |
| 2008 | 3 |
| 2009 | 2 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181633 | MTF Pre-Sutured Tendon | GAT | Substantially Equivalent | |
| K121313 | MTF NEW BONE VOID FILLER | MQV | Substantially Equivalent | |
| K120479 | MTF FASCIA | OWY | Substantially Equivalent | |
| K113167 | MTF NEW BONE VOILD FILLER | MQV | Substantially Equivalent | |
| K110003 | MTF NEW BONE VOID FILLER | MQV | Substantially Equivalent | |
| K103795 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | |
| K103784 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | NUN | Substantially Equivalent | |
| K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | Substantially Equivalent | |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | MBP | Substantially Equivalent | |
| K080405 | SYGNAL DBM | MBP | Substantially Equivalent | |
| K073329 | SYGNAL DBM | MBP | Substantially Equivalent | |
| K070347 | ALLOFIX PUSH-IN ANCHOR | HWC | Substantially Equivalent | |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | MBP | Substantially Equivalent | |
| K062205 | DBX STRIP | MBP | Substantially Equivalent | |
| K053218 | DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX | MQV | Substantially Equivalent | |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | JDW | Substantially Equivalent | |
| K060161 | AFT ALLOGRAFT FILLER TUBE | MBP | Substantially Equivalent | |
| K053339 | ALLOFIX ANCHOR | GAT | Substantially Equivalent | |
| K042829 | DBX STRIP | MBP | Substantially Equivalent | |
| K042125 | AFT | MQV | Substantially Equivalent | |
| K040501 | DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX | NUN | Substantially Equivalent | |
| K040262 | DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX | MQV | Substantially Equivalent | |
| K042038 | MTF ALLOGRAFT ANCHOR | GAT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1000307092 | 1000307092 | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | 1232 MIDVALLEY DRIVE, JESSUP, PA 18434 US | 2026 | |
| 2249062 | 3001236616 | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | 125 MAY ST, STE 300, EDISON, NJ 08837 US | 2026 | |
| 3008812241 | 3006813973 | Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | 1175 Mid Valley Dr, Olyphant, PA 18447 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NUNBone Grafting Material, Human Source
- MQVFiller, Bone Void, Calcium Compound
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- QBOInstruments Designed For Press-Fit Osteochondral Implants
- QKLLipoaspirate Washing System For Aesthetic Body Contouring
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- GXPMethyl Methacrylate For Cranioplasty
- JDWPin, Fixation, Threaded
- HWCScrew, Fixation, Bone
- GATSuture, Nonabsorbable, Synthetic, Polyethylene
- FMFSyringe, Piston
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1067-2024 | AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) | Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues. | Class II | Open, Classified | |
| Z-1066-2024 | 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. | Class II | Open, Classified | |
| Z-0323-2024 | 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. | Class II | Open, Classified | |
| Z-1562-2021 | 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 Number: 227007 | 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery | Class II | Terminated | |
| Z-2548-2019 | 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. | Class II | Terminated | |
| Z-2004-2016 | 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, pelvis, and spine. Product Code: 227005. | 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. | Class II | Terminated | |
| Z-2210-2015 | 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. | Class II | Terminated | |
| Z-2075-2015 | 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. This kit is for single use only. | 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. | Class II | Terminated | |
| Z-1455-2015 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain