Collagen Matrix, Inc.: FDA filings under this applicant name
FDA lists 47 510(k) clearances under the applicant name “Collagen Matrix, Inc.” (first 2001, latest 2025), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 110 days. Since 2017 the median was 188 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Collagen Matrix, Inc. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Collagen Matrix, Inc. is the 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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Collagen Corp. (9 510(k)s)
- Collagen Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Collagen Matrix, Inc.?
FDA lists 47 510(k) clearances under the applicant name “Collagen Matrix, Inc.” (first 2001, latest 2025), across 10 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Collagen Matrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Collagen Matrix, Inc. is 110 days. Since 2017: 188 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Collagen Matrix, Inc.?
The most frequent FDA product codes under this applicant name are NPL (Barrier, Animal Source, Intraoral, 10); KGN (Wound Dressing With Animal-Derived Material(S), 8); MQV (Filler, Bone Void, Calcium Compound, 7).
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. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.