# K261734: Klassic Infection Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Jul 23, 2026 after 58 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936159 (1995). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240683: Rx Knee System, Signature Orthopaedics Pty, Ltd. (2024) Summary page 5.
- K243991: Klassic Knee System - Revision Tibial Baseplate, Total Joint Othopedics, Inc. (2025) Summary page 5.
- K183017: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer, Osteoremedies, LLC (2019) Summary page 5.

## Indications for use
The Klassic® Knee System is intended for prosthetic replacement in treatment of the following: • Patient conditions of non-inflammatory degenerative joint disease (NIDJD): avascular necrosis and osteoarthritis • Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis • Patients with failed previous surgery where pain, deformity, or dysfunction persists • Correctable varus-valgus deformity and moderate flexion contracture • Revision of a previously failed knee arthroplasty • Patients who require a total knee replacement The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat® and the Universal® Cone with Ti-Coat, which are indicated for cementless use. The Klassic® Knee System is also indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organism(s). The Infection Spacer Stem Dowel, Infection Spacer Femur Adapter and Infection Spacer Femur Adapter, Ti are only indicated for this temporary use. These devices are intended for implantation with FDA cleared gentamicin loaded bone cement following implant removal and radical debridement, and in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach for an infection). For the first stage revision, these devices are not intended for use for more than 180 days, at which time they must be explanted and permanent devices implanted, or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.). These devices are only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.

Source page: https://510kreport.com/device/K261734
Methodology: https://510kreport.com/methodology