Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stanmore Implants Worldwide , Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
615 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140898 | PATIENT SPECIFIC DISTAL FEMORAL | Stanmore Implants Worldwide , Ltd. | 2015-01-20 | 287 | 1 |
| K133152 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | Stanmore Implants Worldwide , Ltd. | 2014-01-22 | 61 | 0 |
| K121765 | SCULPTOR ROBOTIC GUIDANCE ARM (RGA) | Stanmore Implants Worldwide , Ltd. | 2013-01-11 | 210 | 0 |
| K121056 | METS MODULAR PROXIMAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-20 | 167 | 0 |
| K121029 | METS MODULAR DISTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | 167 | 0 |
| K121055 | METS MODULAR TOTAL FEMUR | Stanmore Implants Worldwide , Ltd. | 2012-09-19 | 166 | 0 |
| K120992 | METS SMILES TOTAL KNEE REPLACEMENT | Stanmore Implants Worldwide , Ltd. | 2012-09-05 | 156 | 6 |
| K092138 | JTS EXTENDEABLE IMPLANT | Stanmore Implants Worldwide , Ltd. | 2011-03-22 | 615 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda