Miach Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Miach Orthopaedics, Inc.” (first 2025, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 188 days. 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 |
|---|---|---|
| 2025 | 1 | 107 |
| 2026 | 1 | 270 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Miach Orthopaedics, 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 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 3 | 2 |
Review panels
- Orthopedic (3)
Most recent Miach Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | 2026-01-13 | 270 |
| K243578 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | QNI | 2025-03-06 | 107 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200035 | De Novo | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 2020-12-16 |
Recalls
2 product recalls in 2 recall events; 2 initiated in the last five years. Most recent: 2025-12-31.
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 Miach Orthopaedics, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT05398341: A Prospective Cohort Post Market Registry Evaluating Outcomes of Bridge-Enhanced ACL Restoration (BEAR®) (Active not recruiting, started 2023-02-28)
- NCT03348995: The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration (Active not recruiting, started 2018-04-17)
- NCT02664545: Bridge-Enhanced ACL Repair vs ACL Reconstruction (Active not recruiting, started 2016-04)
- NCT02292004: Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial) (Active not recruiting, started 2015-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miach Orthopaedics, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Miach Orthopaedics, Inc.” (first 2025, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Miach Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miach Orthopaedics, Inc. is 188 days.
Which FDA product codes appear under Miach Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are QNI (Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair, 3).
Next steps
- See all 2 Miach Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QNI, Miach Orthopaedics, 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.