Ascension Orthopedics, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Ascension Orthopedics, Inc.” (first 2002, latest 2024), across 15 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 130 days, against 106 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 237 |
| 2014 | 1 | 78 |
| 2015 | 3 | 91 |
| 2016 | 1 | 103 |
| 2017 | 1 | 346 |
| 2018 | 1 | 64 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 29 |
| 2024 | 1 | 196 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ascension Orthopedics, Inc. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 3 | 3 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 3 | 3 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 3 | 3 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 | 2 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
Plus 5 more product codes.
Review panels
- Orthopedic (29)
Most recent Ascension Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233674 | Freedom Wrist Arthroplasty System | JWJ | 2024-05-30 | 196 |
| K233670 | Ascension Silicone MCP; Ascension Silicone PIP | KYJ | 2023-12-14 | 29 |
| K182878 | Integra Salto Total Ankle System | HSN | 2018-12-18 | 64 |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System | HWC | 2017-07-14 | 346 |
| K160830 | Integra External Fixation System | KTT | 2016-07-06 | 103 |
| K152047 | INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid | KWS | 2015-12-23 | 153 |
| K152527 | Integra DigiFuse Cannulated Intramedullary Fusion System | HWC | 2015-10-29 | 56 |
| K151459 | Integra Total Ankle Replacement System | HSN | 2015-08-31 | 91 |
| K142413 | TITAN Modular Total Shoulder System | KWS | 2014-11-14 | 78 |
| K121826 | INTEGRA PROXIMAL HUMERAL PLATE SYSTEM | HRS | 2013-02-13 | 237 |
19 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2018-11-16.
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 Orthopedic (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ascension Orthopedics, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Ascension Orthopedics, Inc.” (first 2002, latest 2024), across 15 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 Orthopedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ascension Orthopedics, Inc. is 90 days. Since 2017: 130 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ascension Orthopedics, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 4); HWC (Screw, Fixation, Bone, 3); KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 3).
Next steps
- See all 29 Ascension Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Ascension Orthopedics, 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.