Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesculap Implant Systems — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
173 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140452 | VEGA KNEE SYSTEM | Aesculap Implant Systems | 2014-03-25 | 29 | 0 |
| K121879 | VEGA KNEE SYSTEM | Aesculap Implant Systems | 2012-07-27 | 29 | 0 |
| K101815 | ENDURO KNEE SYSTEM | Aesculap Implant Systems | 2010-12-20 | 173 | 0 |
| K100623 | AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM | Aesculap Implant Systems | 2010-06-09 | 97 | 1 |
| K090299 | BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS | Aesculap Implant Systems | 2009-04-24 | 77 | 0 |
| K090657 | MODIFICATION TO: S4 SPINAL SYSTEM | Aesculap Implant Systems | 2009-04-20 | 39 | 0 |
| K071945 | S4 SPINAL SYSTEM | Aesculap Implant Systems | 2007-09-20 | 69 | 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