# K982302: Implex Continuum Knee - Hedrocel Tibial Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jul 31, 1998 after 30 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.
107 later devices descend from it; 2 cite it directly.
0 of 108 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 its predicate without a number.
- (no number) Implex CKS Revision Tibial Spacers: named in the summary without a submission number
- (no number) Implex Hedrocel® Revision Femoral Spacers: named in the summary without a submission number
- (no number) Johnson & Johnson PFC Modular Knee System: named in the summary without a submission number
- (no number) Zimmer IB II Modular Knee System: named in the summary without a submission number

## Most influential descendants
- K024161: Nexgen Complete Knee Solution - Trabecular Metal Augments (2003), 106 descendants of its own
- K040487: Trabecular Metal Knee System Augments (2004), 85 descendants of its own
- K053340: Trabecular Metal Tibial and Femoral Cone Augments (2006), 74 descendants of its own
- K100391: Depuy Universal Gription TF Cones (2010), 53 descendants of its own
- K143393: Triathlon Tritanium Cone Augments (2015), 40 descendants of its own

## Indications for use
The Implex Continuum Knee Hedrocel Tibial Spacers are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. This device is intended for cemented use only.

Source page: https://510kreport.com/device/K982302
Methodology: https://510kreport.com/methodology