# K980781: Implex Continuum Knee- Hedrocel Revision Femoral Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: May 22, 1998 after 81 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.
12 later devices descend from it; 1 cites it directly.
0 of 13 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 Femoral Spacers: named in the summary without a submission number
- (no number) Implex Continuum Porous Patella: named in the summary without a submission number
- (no number) Implex Hedrocel Acetabular Restrictor: named in the summary without a submission number

## Most influential descendants
- K103517: Trabecular Metal Femoral Cone Augments (2011), 11 descendants of its own
- K181947: Persona Revision Knee System (2018), 4 descendants of its own
- K200653: AMF Revision TT Cones (2020), 3 descendants of its own
- K240324: EMPOWR Revision Symmetric Knee Cones (2024), 1 descendant of its own
- K191625: Persona Revision Knee System (2019), 1 descendant of its own

## Indications for use
The use of the Continuum Knee System Hedrocel Revision Femoral Spacers are indicated for: a) For cemented use only. b) Total Knee Replacement (TKR) in severely disabled joints as a result of degenerative arthritis; c) Secondary revision of a previously unsuccessful revision femoral component; d) Other knee problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; e) Trauma, or other fractures in which adequate bony fixation cannot be obtained; f) Non-union of the proximal tibia; and g) Salvage of a failed primary or secondary total knee or uni-knee arthroplasty.

Source page: https://510kreport.com/device/K980781
Methodology: https://510kreport.com/methodology