Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avanta Orthopaedics, Inc. · Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
179 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | Avanta Orthopaedics, Inc. | 2003-04-10 | 21 | 0 |
| K021859 | WRIST IMPLANT | Avanta Orthopaedics, Inc. | 2002-12-02 | 179 | 0 |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2002-11-27 | 30 | 0 |
| K013629 | FINGER JOINT PROSTHESIS | Avanta Orthopaedics, Inc. | 2002-01-25 | 81 | 0 |
| K010847 | K'FIX | Avanta Orthopaedics, Inc. | 2001-06-19 | 90 | 0 |
| K011819 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-06-19 | 8 | 1 |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | Avanta Orthopaedics, Inc. | 2001-05-30 | 244 | 0 |
| K010786 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2001-04-11 | 27 | 1 |
| K002644 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 2000-11-20 | 88 | 1 |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | Avanta Orthopaedics, Inc. | 1999-04-29 | 64 | 0 |
| K982268 | ULNAR HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-12-04 | 158 | 0 |
| K982288 | RADIAL HEAD IMPLANT | Avanta Orthopaedics, Inc. | 1998-09-08 | 70 | 1 |
| K981715 | DISTAL RADIUS FRACTURE FIXATION PLATE | Avanta Orthopaedics, Inc. | 1998-07-29 | 75 | 0 |
| K981716 | EXTERNAL FIXATION | Avanta Orthopaedics, Inc. | 1998-07-17 | 63 | 0 |
| K974911 | EXTERNAL FIXATOR | Avanta Orthopaedics, Inc. | 1998-03-16 | 75 | 0 |
| K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | Avanta Orthopaedics, Inc. | 1997-06-03 | 159 | 0 |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | Avanta Orthopaedics, Inc. | 1997-03-25 | 144 | 0 |
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | Avanta Orthopaedics, Inc. | 1997-01-22 | 79 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda