Avanta Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Avanta Orthopaedics, Inc.” (first 1997, latest 2003), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 77 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 4 | 4 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JDW | Pin, Fixation, Threaded | 2 | 2 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 2 | 2 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 | 2 |
| HXA | Prosthesis, Tendon, Passive | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 1 | 1 |
| NDL | Pin, Fixation, Smooth, Metallic | 1 | 1 |
Review panels
- Orthopedic (18)
Most recent Avanta Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | HRS | 2003-04-10 | 21 |
| K021859 | WRIST IMPLANT | JWJ | 2002-12-02 | 179 |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | KWI | 2002-11-27 | 30 |
| K013629 | FINGER JOINT PROSTHESIS | KYJ | 2002-01-25 | 81 |
| K011819 | RADIAL HEAD IMPLANT | KWI | 2001-06-19 | 8 |
| K010847 | K'FIX | NDL | 2001-06-19 | 90 |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | JDR | 2001-05-30 | 244 |
| K010786 | ULNAR HEAD IMPLANT | KXE | 2001-04-11 | 27 |
| K002644 | RADIAL HEAD IMPLANT | KWI | 2000-11-20 | 88 |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | HRS | 1999-04-29 | 64 |
8 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-24.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Avanta Orthopaedics, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Avanta Orthopaedics, Inc.” (first 1997, latest 2003), across 10 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 Avanta Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avanta Orthopaedics, Inc. is 77 days.
Which FDA product codes appear under Avanta Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer, 4); HRS (Plate, Fixation, Bone, 3); JDW (Pin, Fixation, Threaded, 2).
Next steps
- See all 18 Avanta Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWI, Avanta Orthopaedics, 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.