# K953443: Consensus PCL Subsituting Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Medical Products, Inc.
- Decided: Apr 26, 1996 after 284 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: 1 generation back to K912663 (1991). 1 ancestor in all.
9 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912663: Natural-Knee Ultra Congruent Tibial Insert, Intermedics Orthopedics (1991) Summary page 1.

## Most influential descendants
- K133919: Consensus Vitalite Tibial Insert (2014), 7 descendants of its own
- K163167: CKS Plus Knee System (2017), 3 descendants of its own
- K191765: OMNI TiN Coated Apex Knee™ System (2019), 2 descendants of its own
- K160515: PS2 Knee System (2016), 2 descendants of its own
- K191084: The Optimotion Blue Total Knee System (2020), 1 descendant of its own

## Indications for use
The Consensus® PCL Substituting Tibial Insert is indicated for use in: 1. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis. 2. Failed osteotomy or unicompartmental replacements 3. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists.

Source page: https://510kreport.com/device/K953443
Methodology: https://510kreport.com/methodology