Klassic Knee System - Revision Tibial Baseplate— 510(k) K243991

Name: FDA 510(k) clearance K243991
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Substantially Equivalent

Total Joint Othopedics, Inc.

FDA 510(k) clearance K243991 for Klassic Knee System - Revision Tibial Baseplate, Substantially Equivalent on 2025-03-24. Applicant: Total Joint Othopedics, Inc.. Device class: 2.

Clearance details

Applicant: Total Joint Othopedics, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2024-12-26
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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K261563 — Freedom Total Knee System (E-Poly Tibial Liners)2026-08-07
K262251 — ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)2026-07-31
K261734 — Klassic Infection Spacer System2026-07-23
K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
K261032 — NovoKnee (SteriKnee)2026-04-27

More clearances from Total Joint Othopedics, Inc.

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K232414 — Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post2023-09-08
K230537 — Klassic Knee Revision System2023-05-19
K213580 — Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length2021-12-03
K191399 — BIOLOX CONTOURA Ceramic Femoral Head2019-08-28
K171962 — Klassic HD® Hip System2017-07-24

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.