# K983837: Hedrocel Acetabular Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Jul 1, 1999 after 244 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K052996: Porous Titanium Acetabular Shells (2006), 0 descendants of its own

## Indications for use
The indications for use of the Implex Hedrocel® Acetabular Cage are as follows: For cemented or cementless use. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K983837
Methodology: https://510kreport.com/methodology