# K964951: Kinemax Plus Tibial Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Feb 24, 1997 after 76 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 K872379 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915512: Duracon Total Knee System Tibial Components, Pfizer Hospital Products Group, Inc. (1992) Summary page 1.
- K884837: Kinemax Tibial Wedge, Howmedica Corp. (1989) Summary page 1.
- K872379: Insall/Burstein* II Modular Total Knee, Zimmer, Inc. (1987) Summary page 1.
- K915132: MCK Maximum Congruent Knee) Knee System, Biomet, Inc. (1992) Summary page 1.
- K922285: Agc and Maxim Knee Components with NTS, Biomet, Inc. (1992) Summary page 1.
- K896542: Addition to the Continuum Knee System (CKS (TM)), Techmedica, Inc. (1990) Summary page 1.
- K903286: Continuum Knee System (CKS)-Modification, Techmedica, Inc. (1990) Summary page 1.
- K914072: Continuum Knee System (CKS), Techmedica, Inc. (1992) Summary page 1.

## Cited in the summary but kept off the family tree
- K901457: Continuum Knee System (CKS), Techmedica, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

Source page: https://510kreport.com/device/K964951
Methodology: https://510kreport.com/methodology