Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aesculap Implant Systems, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
114 daysmedian FDA review time
267 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153629 | ArcadiusXP C Spinal System | Aesculap Implant Systems, Inc. | 2016-05-25 | 159 | 0 |
| K132421 | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM | Aesculap Implant Systems, Inc. | 2014-01-22 | 170 | 0 |
| K123939 | S4 SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2013-03-12 | 82 | 0 |
| K123352 | S4 SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2012-12-12 | 42 | 0 |
| K111122 | AESCULAP SIBD XP SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2011-08-04 | 105 | 0 |
| K103284 | LAMINOPLASY PLATING SYSTEM | Aesculap Implant Systems, Inc. | 2010-12-02 | 27 | 0 |
| K100802 | AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM | Aesculap Implant Systems, Inc. | 2010-07-20 | 120 | 0 |
| K092143 | EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM | Aesculap Implant Systems, Inc. | 2009-09-22 | 69 | 0 |
| K083004 | MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM | Aesculap Implant Systems, Inc. | 2009-07-02 | 267 | 0 |
| K083311 | AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM | Aesculap Implant Systems, Inc. | 2009-03-04 | 114 | 0 |
| K083495 | MODIFICATION TO: METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | 2009-01-15 | 51 | 0 |
| K082991 | BIOLOX DELTA CERAMIC FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-11-20 | 44 | 0 |
| K081293 | UNIVATION UNICONDYLAR KNEE SYSTEM | Aesculap Implant Systems, Inc. | 2008-09-22 | 138 | 0 |
| K082146 | METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD | Aesculap Implant Systems, Inc. | 2008-09-09 | 41 | 0 |
| K080992 | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTE | Aesculap Implant Systems, Inc. | 2008-09-04 | 150 | 0 |
| K081973 | METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP S | Aesculap Implant Systems, Inc. | 2008-08-07 | 28 | 0 |
| K071916 | METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | 2008-06-02 | 327 | 1 |
| K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CE | Aesculap Implant Systems, Inc. | 2008-05-01 | 287 | 1 |
| K072899 | ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 | Aesculap Implant Systems, Inc. | 2008-02-06 | 118 | 0 |
| K071499 | COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY | Aesculap Implant Systems, Inc. | 2007-09-14 | 106 | 0 |
| K070981 | SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE) | Aesculap Implant Systems, Inc. | 2007-08-21 | 137 | 0 |
| K071220 | COLUMBUS TOTAL KNEE SYSTEM AS | Aesculap Implant Systems, Inc. | 2007-06-01 | 30 | 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