Aesculap Implant System, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Aesculap Implant System, Inc.” (first 2007, latest 2014), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 96 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under B. Braun, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 30 |
| 2013 | 4 | 127 |
| 2014 | 3 | 88 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| MQP | Spinal Vertebral Body Replacement Device | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 2 | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (17)
- Neurology (1)
Most recent Aesculap Implant System, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142707 | AIS Odontoid Fracture Fixation System | HWC | 2014-12-19 | 88 |
| K142150 | AIS MODULIFT VBR SYSTEM | MQP | 2014-10-29 | 85 |
| K133802 | AIS MODULIFT VBR SYSTEM | MQP | 2014-04-17 | 125 |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | OQG | 2013-10-30 | 414 |
| K130887 | S4C NAVIGATION INSTRUMENTS | OLO | 2013-08-13 | 137 |
| K123909 | AESCULAP CESPACE XP | ODP | 2013-04-15 | 117 |
| K130291 | S4 SPINAL SYSTEM | NKB | 2013-04-11 | 64 |
| K122985 | COLUMBUS REVISION KNEE SYSTEM | JWH | 2012-10-26 | 30 |
| K112551 | S4 SPINAL SYSTEM | NKB | 2011-11-21 | 81 |
| K101281 | VEGA KNEE SYSTEM | JWH | 2010-07-30 | 85 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aesculap Implant System, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Aesculap, Inc. (218 510(k)s)
- Aesculap Implant Systems, LLC (51 510(k)s)
- Aesculap Instruments Corp. (13 510(k)s)
- Aesculap Implants Systems, LLC (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aesculap Implant System, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Aesculap Implant System, Inc.” (first 2007, latest 2014), across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aesculap Implant System, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesculap Implant System, Inc. is 96 days.
Which FDA product codes appear under Aesculap Implant System, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); MQP (Spinal Vertebral Body Replacement Device, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Next steps
- See all 18 Aesculap Implant System, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Aesculap Implant System, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.