Smith & Nephew Richards, Inc.: FDA filings under this applicant name
FDA lists 87 510(k) clearances under the applicant name “Smith & Nephew Richards, Inc.” (first 1990, latest 1997), plus 1 PMA decision, across 42 product codes in 5 review panels. Median 510(k) review time under this name: 133 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 Smith+Nephew, 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 8 | 8 |
| ETB | Prosthesis, Partial Ossicular Replacement | 7 | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 5 | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 4 |
| ETA | Replacement, Ossicular Prosthesis, Total | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 3 |
| LYA | Splint, Intranasal Septal | 3 | 3 |
Plus 32 more product codes.
Review panels
- Orthopedic (58)
- Ear, Nose and Throat (23)
- General and Plastic Surgery (5)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
Most recent Smith & Nephew Richards, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965224 | EMPOWER ANTERIOR DIRECT SCREWS | KWP | 1997-05-08 | 129 |
| K963509 | GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON | LPH | 1997-01-27 | 146 |
| K960444 | FINN ROD TO ROD CONNECTOR | KWP | 1997-01-24 | 358 |
| K964163 | TRIMAX NAIL SYSTEM | HSB | 1996-12-27 | 71 |
| K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT | JWH | 1996-12-05 | 157 |
| K963486 | REVISION HIP SYSTEM | JDI | 1996-11-27 | 85 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | JDJ | 1996-09-17 | 81 |
| K962808 | ILIZAROV EXTERNAL FIXATION SYSTEM | KTT | 1996-08-19 | 32 |
| K962137 | GENESIS II CONSTRAINED SYSTEM | JWH | 1996-08-02 | 60 |
| K955767 | COFIED MODULAR SHOULDER SYSTEM | KWS | 1996-04-08 | 109 |
77 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P810020 | PMA | PALACOS R BONE CEMENT | 1984-02-02 |
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew Richards, 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.
- Smith & Nephew, Inc. (556 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Medical Limited (30 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
- Smith & Nephew Inc., Endoscopy Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Richards, Inc.?
FDA lists 87 510(k) clearances under the applicant name “Smith & Nephew Richards, Inc.” (first 1990, latest 1997), plus 1 PMA decision, across 42 product codes in 5 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 Smith & Nephew Richards, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Richards, Inc. is 133 days.
Which FDA product codes appear under Smith & Nephew Richards, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 8); ETB (Prosthesis, Partial Ossicular Replacement, 7); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7).
Next steps
- See all 87 Smith & Nephew Richards, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Smith & Nephew Richards, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.