Depuy Mitek: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Depuy Mitek” (first 2004, latest 2026), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 57 days. Since 2017 the median was 90 days, against 112 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.
Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 87 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 119 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 3 | 102 |
| 2025 | 1 | 57 |
| 2026 | 1 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Depuy Mitek took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | 4 | 4 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 3 | 3 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
Most recent Depuy Mitek 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | KCT | 2026-02-26 | 90 |
| K243790 | GRYPHON X Anchor; HEALIX TRANSTEND Anchor | MAI | 2025-02-05 | 57 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | MAI | 2024-09-11 | 152 |
| K240441 | MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw | MAI | 2024-03-15 | 30 |
| K233675 | FMS VUE Fluid Management and Tissue Debridement System | HRX | 2024-02-26 | 102 |
| K143475 | VAPR Tripolar Suction Electrode | GEI | 2015-04-03 | 119 |
| K120449 | HEALIX ADVANCE PEEK ANCHOR | HWC | 2012-05-11 | 87 |
| K080918 | DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 | NEW | 2008-04-23 | 22 |
| K060664 | FASTIN RC ANCHOR | HWC | 2006-06-06 | 85 |
| K043298 | BLUE ORTHOCORD SUTURE | NEW | 2004-12-10 | 10 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Depuy Mitek.
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 Depuy Mitek is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00436969: ORTHOVISC Shoulder Osteoarthritis Study (Completed, started 2006-12)
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.
- Depuy, Inc. (303 510(k)s)
- DePuy Orthopaedics, Inc. (210 510(k)s)
- Depuy Spine, Inc. (71 510(k)s)
- Depuy Mitek, A Johnson & Johnson Company (58 510(k)s)
- Depuy Ireland UC (50 510(k)s)
- DePuy Synthes (20 510(k)s)
- Depuy Ace Medical Co. (10 510(k)s)
- Depuy Motech Acromed (4 510(k)s)
- Depuy Spine, A Johnson & Johnson Company (4 510(k)s)
- Depuy Mitek, A Johnson and Johnson Company (3 510(k)s)
- Depuy Mitek, Inc., A Johnson and Johnson Company (3 510(k)s)
- Depuy Synthes Spine (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Depuy Mitek?
FDA lists 15 510(k) clearances under the applicant name “Depuy Mitek” (first 2004, latest 2026), across 7 product codes in 3 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 Depuy Mitek?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy Mitek is 57 days. Since 2017: 90 days, versus 112 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Depuy Mitek?
The most frequent FDA product codes under this applicant name are JDR (Staple, Fixation, Bone, 4); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 3); NEW (Suture, Surgical, Absorbable, Polydioxanone, 3).
Next steps
- See all 15 Depuy Mitek clearances with predicates and recalls
- Run predicate analysis for product code JDR, Depuy Mitek'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.