# K012095: The LPS - Continuum TM Hybrid Tibia, Models 32-5886-2Y-XX (Zimmer) and 05-119-XXYY1-0 (Implex)

- Pathway: 510(k) (Special)
- Applicant: Implex Corp.
- Decided: Jul 26, 2001 after 21 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS - Continuum® TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.

Source page: https://510kreport.com/device/K012095
Methodology: https://510kreport.com/methodology