Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Westcon Orthopedics, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K914812 | K-CAP-E, STERILE | Westcon Orthopedics, Inc. | 1992-01-09 | 76 | 0 |
| K912762 | K-CAP-I, STERILE | Westcon Orthopedics, Inc. | 1991-07-18 | 24 | 0 |
| K902053 | K-CAP-I ORTHOPEDIC FIXATION WIRE CAP | Westcon Orthopedics, Inc. | 1990-09-14 | 130 | 0 |
| K901525 | K-CAPE ORTHOPEDIC WIRES AND PINS | Westcon Orthopedics, Inc. | 1990-04-23 | 21 | 0 |
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