Aesculap Implant Systems, LLC: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Aesculap Implant Systems, LLC” (first 2007, latest 2022), across 19 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Since 2017 the median was 110 days, against 92 days for all cleared 510(k)s in the same product codes. 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 | 5 | 84 |
| 2013 | 2 | 129 |
| 2014 | 4 | 66 |
| 2015 | 5 | 99 |
| 2016 | 4 | 166 |
| 2017 | 0 | — |
| 2018 | 1 | 65 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 110 |
| 2022 | 1 | 200 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Aesculap Implant Systems, LLC took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 9 | 9 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 8 | 8 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 7 | 7 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| NKG | Posterior Cervical Screw System | 2 | 2 |
Plus 9 more product codes.
Review panels
- Orthopedic (50)
- Neurology (1)
Most recent Aesculap Implant Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213871 | Ennovate Cervical Spinal and Occiput System | NKG | 2022-07-01 | 200 |
| K210963 | ENNOVATE Spinal System | NKB | 2021-07-19 | 110 |
| K180433 | ENNOVATE® | NKB | 2018-04-26 | 65 |
| K162134 | ENNOVATE Spinal System | NKB | 2016-12-14 | 135 |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | OLO | 2016-07-08 | 198 |
| K153629 | ArcadiusXP C Spinal System | OVE | 2016-05-25 | 159 |
| K153396 | Aesculap OrthoPilot Next Generation | OLO | 2016-05-16 | 174 |
| K151938 | S4 Cervical Spinal and Occiput Systems | NKG | 2015-10-21 | 99 |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | MAX | 2015-08-13 | 115 |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System | JWH | 2015-05-29 | 87 |
41 earlier clearances. See the full list in Caduvo.
Recalls
73 product recalls in 38 recall events; 7 initiated in the last five years. Most recent: 2023-07-20.
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.
Device clinical trials
An industry sponsor named Aesculap Implant Systems, LLC is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00589797: Activ-L™ Artificial Disc Treatment of Degenerative Disc Disease in the Treatment of Degenerative Disc Disease (Completed, started 2007-01)
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 System, Inc. (18 510(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 Systems, LLC?
FDA lists 51 510(k) clearances under the applicant name “Aesculap Implant Systems, LLC” (first 2007, latest 2022), across 19 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 Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aesculap Implant Systems, LLC is 106 days. Since 2017: 110 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Aesculap Implant Systems, LLC?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 9); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 8); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 7).
Next steps
- See all 51 Aesculap Implant Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code NKB, Aesculap Implant Systems, LLC'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.