Ascension Orthopedic: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ascension Orthopedic” (first 2011, latest 2014), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 160 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 228 |
| 2013 | 2 | 123 |
| 2014 | 1 | 228 |
| 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 1 | 1 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Ascension Orthopedic 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140463 | INTEGRA EXTERNAL FIXATION SYSTEM | KTT | 2014-10-10 | 228 |
| K131360 | INTEGRA TITANIUM BONE WEDGE | HRS | 2013-08-07 | 86 |
| K130050 | TITAN REVERSE SHOULDER SYSTEM | KWS | 2013-06-18 | 160 |
| K112438 | TITAN MODULAR TOTAL SHOULDER SYSTEM | KWS | 2012-04-11 | 231 |
| K112481 | FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT | KXE | 2012-04-09 | 224 |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | KYI | 2011-11-04 | 87 |
| K111799 | NUGAIT(TM) SUBTALAR IMPLANT SYSTEM | HWC | 2011-08-19 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Ascension Orthopedic.
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.
- Ascension Orthopedics, Inc. (29 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ascension Orthopedic?
FDA lists 7 510(k) clearances under the applicant name “Ascension Orthopedic” (first 2011, latest 2014), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ascension Orthopedic?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascension Orthopedic is 160 days.
Which FDA product codes appear under Ascension Orthopedic?
The most frequent FDA product codes under this applicant name are KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 2); HRS (Plate, Fixation, Bone, 1); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 7 Ascension Orthopedic clearances with predicates and recalls
- Run predicate analysis for product code KWS, Ascension Orthopedic'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.