Musculoskeletal Transplant Foundation: FDA clearances and approvals
Musculoskeletal Transplant Foundation has 24 FDA 510(k) clearances (first 2004, latest 2019), across 7 product codes in 3 review panels. Median 510(k) review time: 173 days. openFDA lists 9 product recalls by a recalling firm named Musculoskeletal Transplant Foundation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 178 |
| 2013 | 1 | 254 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 268 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Musculoskeletal Transplant Foundation's cleared 510(k)s took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 9 | 9 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 7 | 7 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 3 | 3 |
| NUN | Bone Grafting Material, Human Source | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| OWY | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | 1 | 1 |
Review panels
- Orthopedic (19)
- General and Plastic Surgery (3)
- Dental (2)
Most recent Musculoskeletal Transplant Foundation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181633 | MTF Pre-Sutured Tendon | GAT | 2019-03-15 | 268 |
| K121313 | MTF NEW BONE VOID FILLER | MQV | 2013-01-11 | 254 |
| K120479 | MTF FASCIA | OWY | 2012-11-08 | 266 |
| K113167 | MTF NEW BONE VOILD FILLER | MQV | 2012-01-24 | 89 |
| K110003 | MTF NEW BONE VOID FILLER | MQV | 2011-10-13 | 283 |
| K103795 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | 2011-04-13 | 107 |
| K103784 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | 2011-04-13 | 107 |
| K091217 | DBX DEMINERALIZED BONE MATRIX PUTTY | NUN | 2009-10-02 | 158 |
| K091218 | DBX DEMINERALIZED BONE MATRIX PUTTY | MQV | 2009-09-28 | 154 |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | MBP | 2008-10-10 | 239 |
14 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 8 recall events; 3 initiated in the last five years. Most recent: 2023-12-22.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Musculoskeletal Transplant Foundation's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Musculoskeletal Transplant Foundation have?
Musculoskeletal Transplant Foundation has 24 FDA 510(k) clearances (first 2004, latest 2019), across 7 product codes in 3 review panels.
How long does FDA take to clear Musculoskeletal Transplant Foundation's 510(k)s?
The median time from FDA receipt to decision across Musculoskeletal Transplant Foundation's cleared 510(k)s is 173 days.
What devices does Musculoskeletal Transplant Foundation make?
Its most frequent FDA product codes are MQV (Filler, Bone Void, Calcium Compound, 9); MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), 7); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 3).
Has Musculoskeletal Transplant Foundation had device recalls?
openFDA lists 9 product recalls in 8 recall events by a recalling firm whose name matches Musculoskeletal Transplant Foundation; the most recent began 2023-12-22. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 24 Musculoskeletal Transplant Foundation clearances with predicates and recalls
- Run predicate analysis for product code MQV, Musculoskeletal Transplant Foundation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.