# K162256: Klassic Femur, Porous, Klassic Tibial Baseplate, Porous

- Pathway: 510(k) (Traditional)
- Applicant: Total Joint Orthopedics, Inc.
- Decided: Oct 27, 2016 after 77 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936079 (1994). 54 ancestors in all.
No later device cites it as a predicate yet.
1 of 55 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112906: Klassic Knee System, Total Joint Orthopedics, Inc. (2012) Summary page 5.
- K153776: Optetrak One Logic Femoral Components, Exactech, Inc. (2016) Summary page 5.
- K061223: Advance Total Knee System, Wrightmedicaltechnologyinc (2006) Summary page 5.
- K123486: Triathlon Tritanium Tibial Baseplate, Stryker (2013) 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

Source page: https://510kreport.com/device/K162256
Methodology: https://510kreport.com/methodology