# K973164: Howmedica Total Stabilizer Knee Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Nov 20, 1997 after 87 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070095: Triathlon TS Knee System (2007), 64 descendants of its own
- K072221: Modification to Triathlon TS Knee System (2007), 35 descendants of its own
- K123166: Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon All-Polyethylene Posterior Stabilizing (P (2013), 33 descendants of its own
- K141056: Triathlon Knee System Posterior Stabilized Components (2014), 28 descendants of its own
- K140942: Klassic Knee Tibial Stem Extension (2014), 27 descendants of its own

## Recalls of this device
- Sep 21, 2015 · Class II · Z-0362-2016: Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).

## Indications for use
The Howmedica Total Stabilizer Knee Components (Stabilizer femoral component, stabilizer tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges) are intended to be used along with previously released Duracon tibial and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. This total knee system IS intended to be used to relieve pain and instability of the knee joint as a result of non-inflammatory joint disease, inflammatory joint disease, trauma, or failed previous prosthesis. The Howmedica Total Stabilizer femoral component and tibial insert components are specifically intended to be used when the cruciate ligaments are absent, inadequate, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to the absence of the patella. The collateral ligaments may or may not be intact. In addition, these components may be used in revision of a failed previous prosthesis where the cruciate ligaments are absent. The Howmedica tibial wedges are intended to be used with the Howmedica Universal tibial baseplate to augment bone loss on the surface of the tibia. Tibial bone loss may be observed in primary or revision total knee arthroplasty. The Howmedica Modular Offset Adaptor is intended to be used in situations where a stem extender is being used, and the tibial baseplate or femoral component requires offsetting to allow optimal coverage of the prepared bone surfaces. The Howmedica Stem Extenders are intended to be used with Duracon/ Kinemax femoral/tibial components in primary/revision total knee arthroplasty where additional stability is required. The Howmedica Total Stabilizer Knee Components are intended to be implanted using bone cement.

Source page: https://510kreport.com/device/K973164
Methodology: https://510kreport.com/methodology