# K994076: Implex Hedrocel PS Tibial Component, Model Hedrocel Posterior Stabilized Tibial Component 05-XXX-Yyyyy

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Feb 18, 2000 after 78 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 summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) Hedrocel Unity Tibial Component, Cemented: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K953164: Alalysis Package for Dental Applications for Xpeed, Xpress, Xvision, Toshiba America Medical Systems, In.C (1995). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Implex Hedrocel Posterior Stabilized (PS) Tibial Component is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the Hedrocel PS Tibial Component 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/K994076
Methodology: https://510kreport.com/methodology