Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Total Joint Othopedics, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
184 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 | 88 | 0 |
| K232414 | Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS- | Total Joint Othopedics, Inc. | 2023-09-08 | 29 | 0 |
| K230537 | Klassic Knee Revision System | Total Joint Othopedics, Inc. | 2023-05-19 | 81 | 0 |
| K213580 | Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head | Total Joint Othopedics, Inc. | 2021-12-03 | 23 | 0 |
| K191399 | BIOLOX CONTOURA Ceramic Femoral Head | Total Joint Othopedics, Inc. | 2019-08-28 | 96 | 0 |
| K171962 | Klassic HD® Hip System | Total Joint Othopedics, Inc. | 2017-07-24 | 24 | 0 |
| K161073 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2016-10-19 | 184 | 0 |
| K143407 | Klassic HD Hip System | Total Joint Othopedics, Inc. | 2014-12-23 | 25 | 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