Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Total Joint Orthopedics, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
268 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 | 58 | 0 |
| K220483 | Platform® Acetabular System | Total Joint Orthopedics, Inc. | 2022-09-23 | 217 | 0 |
| K211877 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2022-06-22 | 370 | 0 |
| K211602 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2021-07-23 | 60 | 0 |
| K202740 | Klassic Knee System Tibial Inserts, PS-Max | Total Joint Orthopedics, Inc. | 2020-10-09 | 21 | 0 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Kn | Total Joint Orthopedics, Inc. | 2019-03-29 | 98 | 0 |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, K | Total Joint Orthopedics, Inc. | 2019-03-15 | 35 | 0 |
| K180929 | Klassic HD® Hip System | Total Joint Orthopedics, Inc. | 2018-05-09 | 30 | 0 |
| K180159 | Klassic® Knee System | Total Joint Orthopedics, Inc. | 2018-03-09 | 49 | 0 |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klas | Total Joint Orthopedics, Inc. | 2017-10-27 | 28 | 0 |
| K162422 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2016-10-28 | 59 | 0 |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | Total Joint Orthopedics, Inc. | 2016-10-27 | 77 | 0 |
| K153310 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015-12-17 | 30 | 0 |
| K153075 | Klassic Knee System | Total Joint Orthopedics, Inc. | 2015-11-13 | 21 | 0 |
| K151440 | Klassic HD Hip System | Total Joint Orthopedics, Inc. | 2015-09-03 | 97 | 0 |
| K150105 | Klassic Knee System-Sombrero Patella | Total Joint Orthopedics, Inc. | 2015-02-17 | 28 | 0 |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Total Joint Orthopedics, Inc. | 2014-10-09 | 80 | 0 |
| K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION | Total Joint Orthopedics, Inc. | 2014-05-16 | 32 | 0 |
| K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POR | Total Joint Orthopedics, Inc. | 2014-03-13 | 86 | 0 |
| K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD | Total Joint Orthopedics, Inc. | 2014-02-12 | 268 | 0 |
| K112906 | KLASSIC KNEE SYSTEM | Total Joint Orthopedics, Inc. | 2012-02-01 | 121 | 0 |
| K100445 | KLASSIC HD HIP SYSTEM | Total Joint Orthopedics, Inc. | 2010-12-03 | 289 | 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