Collagen Matrix, Inc.: FDA clearances and approvals
Collagen Matrix, Inc. has 47 FDA 510(k) clearances (first 2001, latest 2025), across 10 product codes in 4 review panels. Median 510(k) review time: 110 days. Since 2017 its median was 188 days, against 107 days for all cleared 510(k)s in the same product codes. openFDA lists 15 product recalls by a recalling firm named Collagen Matrix, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 107 |
| 2013 | 0 | — |
| 2014 | 4 | 115 |
| 2015 | 2 | 226 |
| 2016 | 1 | 286 |
| 2017 | 4 | 162 |
| 2018 | 0 | — |
| 2019 | 1 | 232 |
| 2020 | 1 | 67 |
| 2021 | 1 | 241 |
| 2022 | 2 | 212 |
| 2023 | 1 | 33 |
| 2024 | 4 | 70 |
| 2025 | 1 | 215 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Collagen Matrix, Inc.'s cleared 510(k)s took a median 188 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | 10 | 10 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 8 | 8 |
| MQV | Filler, Bone Void, Calcium Compound | 7 | 7 |
| NPM | Bone Grafting Material, Animal Source | 7 | 7 |
| GXQ | Dura Substitute | 5 | 5 |
| JXI | Cuff, Nerve | 4 | 4 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| FTM | Mesh, Surgical | 1 | 1 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| OLC | Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen | 1 | 1 |
Review panels
- Dental (20)
- Neurology (9)
- Orthopedic (9)
- General and Plastic Surgery (9)
Most recent Collagen Matrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - Repair | GXQ | 2025-11-18 | 215 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | KGN | 2024-12-19 | 83 |
| K242302 | RejuvaKnee Collagen Meniscus Implant | OLC | 2024-10-02 | 58 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | NPL | 2024-05-01 | 216 |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix | MQV | 2024-03-12 | 28 |
| K231942 | Mineral Collagen Composite Bioactive Extra Moldable | MQV | 2023-08-02 | 33 |
| K221735 | Mineral Collagen Composite Bioactive Moldable | MQV | 2022-12-20 | 188 |
| K213341 | Fibrillar Collagen Wound Dressing | KGN | 2022-05-31 | 236 |
| K202183 | Porcine Mineral Collagen Composite | NPM | 2021-04-02 | 241 |
| K201859 | Porcine Mineral Collagen Composite Moldable | NPM | 2020-09-11 | 67 |
37 earlier clearances. See the full list in Caduvo.
Recalls
15 product recalls in 9 recall events; 3 initiated in the last five years. Most recent: 2022-08-03.
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.
Device clinical trials
Collagen Matrix, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04775537: OssiMend BA in Posterolateral Instrumented Lumbar Fusion (Recruiting, started 2021-01-21)
Frequently asked questions
How many FDA 510(k) clearances does Collagen Matrix, Inc. have?
Collagen Matrix, Inc. has 47 FDA 510(k) clearances (first 2001, latest 2025), across 10 product codes in 4 review panels.
How long does FDA take to clear Collagen Matrix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Collagen Matrix, Inc.'s cleared 510(k)s is 110 days. Since 2017: 188 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does Collagen Matrix, Inc. make?
Its most frequent FDA product codes are NPL (Barrier, Animal Source, Intraoral, 10); KGN (Wound Dressing With Animal-Derived Material(S), 8); MQV (Filler, Bone Void, Calcium Compound, 7).
Has Collagen Matrix, Inc. had device recalls?
openFDA lists 15 product recalls in 9 recall events by a recalling firm whose name matches Collagen Matrix, Inc; the most recent began 2022-08-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 47 Collagen Matrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NPL, Collagen Matrix, Inc.'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.