Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesculap Implant System, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
414 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142707 | AIS Odontoid Fracture Fixation System | Aesculap Implant System, Inc. | 2014-12-19 | 88 | 0 |
| K142150 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-10-29 | 85 | 0 |
| K133802 | AIS MODULIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2014-04-17 | 125 | 0 |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | Aesculap Implant System, Inc. | 2013-10-30 | 414 | 0 |
| K130887 | S4C NAVIGATION INSTRUMENTS | Aesculap Implant System, Inc. | 2013-08-13 | 137 | 0 |
| K123909 | AESCULAP CESPACE XP | Aesculap Implant System, Inc. | 2013-04-15 | 117 | 0 |
| K130291 | S4 SPINAL SYSTEM | Aesculap Implant System, Inc. | 2013-04-11 | 64 | 0 |
| K122985 | COLUMBUS REVISION KNEE SYSTEM | Aesculap Implant System, Inc. | 2012-10-26 | 30 | 1 |
| K112551 | S4 SPINAL SYSTEM | Aesculap Implant System, Inc. | 2011-11-21 | 81 | 0 |
| K101281 | VEGA KNEE SYSTEM | Aesculap Implant System, Inc. | 2010-07-30 | 85 | 0 |
| K100147 | S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM | Aesculap Implant System, Inc. | 2010-07-23 | 185 | 0 |
| K083186 | AESCULAP HYDROLIFT VBR SYSTEM | Aesculap Implant System, Inc. | 2010-03-04 | 491 | 0 |
| K090375 | ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210 | Aesculap Implant System, Inc. | 2009-06-23 | 126 | 0 |
| K083772 | COLUMBUS REVISION KNEE SYSTEM | Aesculap Implant System, Inc. | 2009-06-04 | 168 | 1 |
| K090354 | LAMINOPLASTY PLATING SYSTEM | Aesculap Implant System, Inc. | 2009-05-12 | 90 | 0 |
| K080547 | ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 | Aesculap Implant System, Inc. | 2008-05-23 | 85 | 0 |
| K080584 | METHA SHORT STEM HIP SYSTEM | Aesculap Implant System, Inc. | 2008-05-09 | 67 | 0 |
| K070178 | AESCULAP RESORBABLE PIN, MODEL FR735 | Aesculap Implant System, Inc. | 2007-04-30 | 101 | 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