# K983835: Implex Continuum Patella-Revision Hedrocel Patella

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Mar 15, 1999 after 136 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: 2 generations back to K882322 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K971789: Implex Continuum Porous Patellar, Implex Corp. (1997). Our OCR of the scanned summary read K971879, FDA’s number for Scanning Device Accessory for Use with the CB Erbium/2.94… (Continuum Biomedical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Continuum Porous Patella, Implex Corp.”.
- K960856: Konstruct Patellar Component, Biomet, Inc. (1996) Summary page 1.

## Indications for use
The Implex Revision Hedrocel® Patella is intended as the patellar component of the Continuum Knee System whose indications for use include: 1) noninflamatory degenerative joint disease including osteoarthritis or traumatic arthritis, 2) rheumatoid arthritis, 3) correction of functional deformity, 4) revision procedures where other treatments or devices have failed, ‘5) treatment of fractures that are unmanageable using other techniques, and 6) complications from failed prosthesis. This device is intended for use with bone cement and supplemental fixation by means of suture attachment. Supplemental suture attachment may be used in cases where additional device support can be obtained.

Source page: https://510kreport.com/device/K983835
Methodology: https://510kreport.com/methodology