Plus Orthopedics AG: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Plus Orthopedics AG” (first 2006, latest 2007), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (3)
- Neurology (2)
Most recent Plus Orthopedics AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070928 | CERAMIC BALL HEADS, 28, 32 AND 36 MM | LZO | 2007-08-01 | 120 |
| K070731 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM | HAW | 2007-07-31 | 138 |
| K070278 | POLARCUP DUAL MOBILITY SYSTEM | LPH | 2007-04-16 | 77 |
| K063578 | PROMOS MODULAR SHOULDER SYSTEM | HSD | 2007-03-02 | 92 |
| K061362 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM | HAW | 2006-10-06 | 143 |
Recalls
openFDA lists no recalls under a recalling firm named Plus Orthopedics AG.
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 (38 510(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 AG?
FDA lists 5 510(k) clearances under the applicant name “Plus Orthopedics AG” (first 2006, latest 2007), 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 Plus Orthopedics AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Plus Orthopedics AG is 120 days.
Which FDA product codes appear under Plus Orthopedics AG?
The most frequent FDA product codes under this applicant name are HAW (Neurological Stereotaxic Instrument, 2); HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, 1); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1).
Next steps
- See all 5 Plus Orthopedics AG clearances with predicates and recalls
- Run predicate analysis for product code HAW, Plus Orthopedics AG'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.