Depuy Mitek, A Johnson & Johnson Company: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Depuy Mitek, A Johnson & Johnson Company” (first 2004, latest 2015), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 72 days. 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 | 6 | 86 |
| 2013 | 10 | 90 |
| 2014 | 4 | 48 |
| 2015 | 1 | 149 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 18 | 18 |
| HWC | Screw, Fixation, Bone | 12 | 12 |
| JDR | Staple, Fixation, Bone | 7 | 7 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| HRX | Arthroscope | 4 | 4 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 3 | 3 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
Review panels
Most recent Depuy Mitek, A Johnson & Johnson Company 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143660 | Milagro / Milagro Advance Interference Screw | MAI | 2015-05-21 | 149 |
| K142574 | 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, | MBI | 2014-10-24 | 42 |
| K140896 | VAPR ARCTIC SUCTION ELECTRODE | GEI | 2014-08-05 | 119 |
| K141259 | GRYPHON BR ANCHOR WITH PERMACORD, GRYPHON BR DS ANCHOR WITH PERMACORD,GRYPHON PEEK ANCHOR WITH PERMACORD, GRYPHON PEEK | MAI | 2014-06-10 | 26 |
| K133794 | 4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE, 5.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 | MAI | 2014-02-04 | 53 |
| K132241 | GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T | MAI | 2013-11-05 | 110 |
| K130814 | RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM | MBI | 2013-08-01 | 129 |
| K131974 | HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) | MAI | 2013-07-25 | 27 |
| K131191 | 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS | HRX | 2013-07-22 | 87 |
| K130912 | OMNICUT RESECTION BLADE | HRX | 2013-06-14 | 73 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Depuy Mitek, A Johnson & Johnson Company.
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.
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 Ireland UC (50 510(k)s)
- DePuy Synthes (20 510(k)s)
- Depuy Mitek (15 510(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, A Johnson & Johnson Company?
FDA lists 58 510(k) clearances under the applicant name “Depuy Mitek, A Johnson & Johnson Company” (first 2004, latest 2015), across 8 product codes in 2 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, A Johnson & Johnson Company?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy Mitek, A Johnson & Johnson Company is 72 days.
Which FDA product codes appear under Depuy Mitek, A Johnson & Johnson Company?
The most frequent FDA product codes under this applicant name are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 18); HWC (Screw, Fixation, Bone, 12); JDR (Staple, Fixation, Bone, 7).
Next steps
- See all 58 Depuy Mitek, A Johnson & Johnson Company clearances with predicates and recalls
- Run predicate analysis for product code MAI, Depuy Mitek, A Johnson & Johnson Company'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.