# K981560: Implex Continuum Knee System: Porous Tibial Component Model Number 05-230 System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jun 8, 1998 after 38 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
Longest line of descent: 1 generation back to K882322 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K882322: Continuum Knee System (CKS), Buckman Co., Inc. (1989) Summary page 2.
- K940813: Osteonics (R) Series 7000 Total Knee, Osteonics Corp. (1995) Summary page 2.
- K951987: Genesis II Total Knee System, Smith & Nephew Richards, Inc. (1995) Summary page 2.
- K926228: Duracon Cruciform Tibial Baseplate, Howmedica Corp. (1994) Summary page 2.

## Indications for use
The Continum Knee System (CKS):Porous Tibial Component is intended for use in the total kee joint where severe degenration, trauma, or pathology of the knee indicates cemented total knee arthroplasty. The CKS is indicated for: a) Total Knee Replacement in severely disabled joints as a result of degenerative arthritis; b) Secondary revision of a previously unsuccessful tibial component; c) Other knee problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; d) Trauma, or other fractures in which adequate bony fixation cannot be obtained; e) Non-union of the proximal tibia; and f) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

Source page: https://510kreport.com/device/K981560
Methodology: https://510kreport.com/methodology