Depuy Ace Medical Co.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Depuy Ace Medical Co.” (first 1997, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 54 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 6 | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| HTN | Washer, Bolt Nut | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Depuy Ace Medical Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990392 | DEPUY ACE SPIDER PLATE | HRS | 1999-03-23 | 42 |
| K990120 | MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE | HSB | 1999-02-01 | 19 |
| K984458 | DEPUY ACE SPIDER PLATE | HRS | 1998-12-31 | 16 |
| K983853 | DEPUY ACE TIMAX META PLATE | HRS | 1998-12-22 | 53 |
| K983265 | DEPUY ACE COMPOSITE LOCKING NUT | HTN | 1998-10-26 | 39 |
| K982347 | DEPUY ACE TIMAX PILON PLATE | HRS | 1998-08-31 | 56 |
| K981775 | DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE | HRS | 1998-07-29 | 70 |
| K974245 | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY ACE FIXED TIP TONG PIN-MRI | LXT | 1998-05-22 | 191 |
| K970503 | DEPUY ACE TROCHANTERIC SIDE PLATE | HRS | 1997-04-30 | 79 |
| K970202 | DEPUY ACE AIM TITANIUM TIBIAL NAIL | HSB | 1997-03-21 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Depuy Ace Medical Co..
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 Mitek, A Johnson & Johnson Company (58 510(k)s)
- Depuy Ireland UC (50 510(k)s)
- DePuy Synthes (20 510(k)s)
- Depuy Mitek (15 510(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 Ace Medical Co.?
FDA lists 10 510(k) clearances under the applicant name “Depuy Ace Medical Co.” (first 1997, latest 1999), across 4 product codes 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 Depuy Ace Medical Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy Ace Medical Co. is 54 days.
Which FDA product codes appear under Depuy Ace Medical Co.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 6); HSB (Rod, Fixation, Intramedullary And Accessories, 2); HTN (Washer, Bolt Nut, 1).
Next steps
- See all 10 Depuy Ace Medical Co. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Depuy Ace Medical Co.'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.