Smith & Nephew, Inc., Orthopaedic Div.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew, Inc., Orthopaedic Div.” (first 1996, latest 1999), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 56 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Smith & Nephew, Inc., Orthopaedic Div. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | JDI | 1999-06-03 | 31 |
| K970635 | TITANIUM SPINAL ROD SYSTEM | KWQ | 1997-08-14 | 175 |
| K971414 | ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS | LZO | 1997-07-16 | 91 |
| K970748 | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM | KTT | 1997-05-09 | 67 |
| K970751 | HEIDELBERG EXTERNAL FIXATOR | JDW | 1997-04-16 | 44 |
| K970713 | COMPASS UNIVERSAL HINGE | JDW | 1997-04-03 | 35 |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | JDI | 1997-02-28 | 29 |
| K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM | MEH | 1997-02-28 | 30 |
| K963255 | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT | JWH | 1997-01-02 | 136 |
| K962784 | ULTIUM SPINAL PLATING SYSTEM | MNH | 1996-10-02 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew, Inc., Orthopaedic Div..
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. (547 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Medical Limited (20 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(k)s)
- Smith & Nephew Medical, Ltd. (12 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew, Inc., Orthopaedic Div.?
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew, Inc., Orthopaedic Div.” (first 1996, latest 1999), across 8 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 Smith & Nephew, Inc., Orthopaedic Div.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew, Inc., Orthopaedic Div. is 56 days.
Which FDA product codes appear under Smith & Nephew, Inc., Orthopaedic Div.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 2); JDW (Pin, Fixation, Threaded, 2); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 1).
Next steps
- See all 10 Smith & Nephew, Inc., Orthopaedic Div. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Smith & Nephew, Inc., Orthopaedic Div.'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.