Plus Orthopedics: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Plus Orthopedics” (first 1997, latest 2004), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 |
|---|---|---|---|
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 7 | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 6 | 6 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 5 | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 4 | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (37)
- Neurology (1)
Most recent Plus Orthopedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032126 | PROMOS SHOULDER | HSD | 2004-01-08 | 182 |
| K033763 | MODIFICATION TO SLIM GLIDING NAIL SYSTEM | KTT | 2003-12-18 | 16 |
| K032709 | MODULAR PLUS HIP STEM | LWJ | 2003-09-23 | 21 |
| K032548 | IP-XS COMPRESSION NAIL SYSTEM | HSB | 2003-09-10 | 23 |
| K032215 | VKS/TC-PLUS REVISION KNEE | JWH | 2003-08-08 | 18 |
| K032052 | UC-PLUS SOLUTION UNICONDYLAR KNEE | HRY | 2003-07-25 | 23 |
| K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM | JDI | 2003-06-06 | 53 |
| K030971 | MODIFICATION TO MODULAR PLUS REVISION STEM | LWJ | 2003-04-24 | 27 |
| K024134 | UNI HIP STEM | LWJ | 2003-01-15 | 30 |
| K023667 | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE | KRO | 2002-12-24 | 54 |
28 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2005-01-04.
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.
- Plus Orthopedics AG (5 510(k)s)
- Plus EV Holdings Dba Intimate Rose (3 510(k)s)
- Plus EV Holdings, Inc. D/B/A Intimate Rose (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Plus Orthopedics?
FDA lists 38 510(k) clearances under the applicant name “Plus Orthopedics” (first 1997, latest 2004), across 15 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 Plus Orthopedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plus Orthopedics is 62 days.
Which FDA product codes appear under Plus Orthopedics?
The most frequent FDA product codes under this applicant name are LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, 7); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 6); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 5).
Next steps
- See all 38 Plus Orthopedics clearances with predicates and recalls
- Run predicate analysis for product code LWJ, Plus Orthopedics'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.