Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.” (first 2017, latest 2019), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 269 days. Since 2017 the median was 269 days, against 104 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 |
|---|---|---|
| 2017 | 1 | 487 |
| 2018 | 2 | 268 |
| 2019 | 2 | 176 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
Review panels
- Orthopedic (4)
- General Hospital (1)
Most recent Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192745 | DePuy Synthes Trauma Screws | HWC | 2019-11-26 | 57 |
| K181933 | DePuy Synthes Sterilization Container System | KCT | 2019-05-09 | 294 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | HRS | 2018-11-01 | 269 |
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional | JDQ | 2018-06-21 | 267 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S | HRS | 2017-06-30 | 487 |
Recalls
openFDA lists no recalls under a recalling firm named Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc..
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.
- Synthes (Usa) (407 510(k)s)
- Synthes Spine (54 510(k)s)
- Synthes (USA) Products, LLC (45 510(k)s)
- Synthes (26 510(k)s)
- Synthes USA Products, LLC (16 510(k)s)
- Synthes USA (11 510(k)s)
- Synthes (Usa) Products, LLC/Norian Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.” (first 2017, latest 2019), across 4 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 Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. is 269 days. Since 2017: 269 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 2); HWC (Screw, Fixation, Bone, 1); JDQ (Cerclage, Fixation, 1).
Next steps
- See all 5 Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Synthes (Usa) Products, LLC / Depuy 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.