# K980637: Implex Continuum Knee Unity Tibial Component

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Dec 16, 1998 after 300 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 its predicate without a number.
- (no number) Implex Continuum Knee System, Cemented: named in the summary without a submission number
- (no number) Implex Continuum All-Poly Tibial Component, Cemented: named in the summary without a submission number
- (no number) Continuum Porous Patella, Cemented: named in the summary without a submission number
- (no number) HEP Acetabular Cup, Cemented: named in the summary without a submission number
- (no number) Protek All-Poly Component: named in the summary without a submission number
- (no number) Richards Medical Tricon-P: named in the summary without a submission number
- (no number) Richards Medical Tricon-M: named in the summary without a submission number

## Indications for use
The Implex Continuum Knee Unity Tibial Component is indicated for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.

Source page: https://510kreport.com/device/K980637
Methodology: https://510kreport.com/methodology