Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesculap Implant Systems, LLC · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
218 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Implant Systems, LLC | 2022-07-01 | 200 | 0 |
| K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2021-07-19 | 110 | 0 |
| K180433 | ENNOVATE® | Aesculap Implant Systems, LLC | 2018-04-26 | 65 | 0 |
| K162134 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | 2016-12-14 | 135 | 0 |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | Aesculap Implant Systems, LLC | 2016-07-08 | 198 | 0 |
| K153396 | Aesculap OrthoPilot Next Generation | Aesculap Implant Systems, LLC | 2016-05-16 | 174 | 0 |
| K151938 | S4 Cervical Spinal and Occiput Systems | Aesculap Implant Systems, LLC | 2015-10-21 | 99 | 0 |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | Aesculap Implant Systems, LLC | 2015-08-13 | 115 | 0 |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, E | Aesculap Implant Systems, LLC | 2015-05-29 | 87 | 0 |
| K141694 | AESCULAP ORTHOPILOT NEXT GENERATION | Aesculap Implant Systems, LLC | 2015-02-24 | 245 | 0 |
| K150062 | Excia Total Hip System | Aesculap Implant Systems, LLC | 2015-02-09 | 27 | 0 |
| K143106 | VEGA Knee System | Aesculap Implant Systems, LLC | 2014-11-21 | 23 | 0 |
| K140915 | EXCIA TOTAL HIP SYSTEM | Aesculap Implant Systems, LLC | 2014-07-21 | 102 | 0 |
| K131167 | UNIVATION | Aesculap Implant Systems, LLC | 2013-10-17 | 176 | 0 |
| K120955 | COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM | Aesculap Implant Systems, LLC | 2012-12-17 | 262 | 0 |
| K121801 | QUINTEX CERVICAL PLATING SYSTEM | Aesculap Implant Systems, LLC | 2012-09-11 | 84 | 0 |
| K112682 | METHA HIP SYSTEM | Aesculap Implant Systems, LLC | 2012-03-19 | 186 | 0 |
| K110864 | BIOSPINE VBR SYSTEM | Aesculap Implant Systems, LLC | 2011-06-15 | 78 | 0 |
| K102057 | TARGON FN SYSTEM | Aesculap Implant Systems, LLC | 2010-12-21 | 152 | 0 |
| K102424 | PREVISION HIP SYSTEM WITH RECON RING | Aesculap Implant Systems, LLC | 2010-12-09 | 106 | 0 |
| K102505 | HTO PLATING SYSTEM | Aesculap Implant Systems, LLC | 2010-11-24 | 84 | 0 |
| K100243 | QUINTEX CERVICAL PLATING SYSTEM | Aesculap Implant Systems, LLC | 2010-09-02 | 218 | 1 |
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