Stanmore Implants Worldwide , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Stanmore Implants Worldwide , Ltd.” (first 2011, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 167 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 166 |
| 2013 | 1 | 210 |
| 2014 | 1 | 61 |
| 2015 | 1 | 287 |
| 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 |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 5 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Stanmore Implants Worldwide , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | KRO | 2015-01-20 | 287 |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | KRO | 2014-01-22 | 61 |
| K121765 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | OLO | 2013-01-11 | 210 |
| K121056 | METS MODULAR PROXIMAL FEMUR | JDI | 2012-09-20 | 167 |
| K121055 | METS MODULAR TOTAL FEMUR | JDI | 2012-09-19 | 166 |
| K121029 | METS MODULAR DISTAL FEMUR | KRO | 2012-09-19 | 167 |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | KRO | 2012-09-05 | 156 |
| K092138 | JTS EXTENDEABLE IMPLANT | KRO | 2011-03-22 | 615 |
Recalls
8 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-07-04.
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.
- Stanmore Worldwide Implants , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stanmore Implants Worldwide , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Stanmore Implants Worldwide , Ltd.” (first 2011, latest 2015), across 3 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 Stanmore Implants Worldwide , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stanmore Implants Worldwide , Ltd. is 167 days.
Which FDA product codes appear under Stanmore Implants Worldwide , Ltd.?
The most frequent FDA product codes under this applicant name are KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, 5); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 2); OLO (Orthopedic Stereotaxic Instrument, 1).
Next steps
- See all 8 Stanmore Implants Worldwide , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KRO, Stanmore Implants Worldwide , Ltd.'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.