# K990330: Cross Linked Polyethylene Acetabular Components,Model XX-YY-Zzzzzz

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Mar 1, 2000 after 393 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 HEP (Hedrocel) Acetabular Cup: named in the summary without a submission number
- (no number) Implex Revision HEP (Hedrocel) Acetabular Cup: named in the summary without a submission number
- (no number) Implex A-230 Acetabular Cup System: named in the summary without a submission number
- (no number) Implex Modular Elliptical Porous Cup System: named in the summary without a submission number
- (no number) DePuy Duraloc Acetabular Cup System: named in the summary without a submission number
- (no number) Osteonics Cross-Fire Acetabular Components: named in the summary without a submission number

## Indications for use
The Implex Cross-Linked Polysthylene Acetabular Components are intended to be used with the below listed, legally marketed Implex Acetabular Component Replacement Systems to resurface the acetabular socket in cemented or cementless total hip arthroplasty. Implex Cross-Linked Polysthylene Acetabular Components are for use with the following legally marketed Implex devices with 28 mm femoral heads: 1. The Implex HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options. 2. The Implex Revision HEP (Hedrocel) Acetabular Cup, cemented & cementless. The permitted OD size is 52 mm and greater for the 0° face-angle, and OD sizes 50 mm and greater for the 10 and 20° face-angle options. 3. The Implex A-230 (porous beads) Acetabular Cup System, cemented & cementless. The permitted OD size is 52 mm and greater for the 0°, 10 ° and 20° face angle options. 4. The Implex Modular Elliptical Porous Cup. The permitted OD size is 54 mm and greater for the 0°, 10° and 20° face angle options.

Source page: https://510kreport.com/device/K990330
Methodology: https://510kreport.com/methodology