# K971705: Implex Hep Acetabular Cup System, Cemented

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Aug 6, 1997 after 90 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.
16 later devices descend from it; 1 cites it directly.
0 of 17 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 A-230 Porous Acetabular Cup System, Cemented: 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
- K992153: PE-Plus Acetabular Cup (1999), 15 descendants of its own
- K112158: Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads (2012), 13 descendants of its own
- K141327: Minima S System (2014), 5 descendants of its own
- K152903: REVIVAL (TM) Modular Revision Hip Stem (2016), 4 descendants of its own
- K140975: Mastersl Femoral Stem (2014), 4 descendants of its own

## Indications for use
The use of the Implex HEP Acetabular Cup System, Cemented, is indicated for: a) Total Hip Replacement in severely disabled joints as a result of degenerative arthritis or avascular necrosis; b) Secondary revision of a previously unsuccessful acetabular component; c) Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results; d) Fracture dislocation of the hip, or irreducible fractures in which adequate fixation cannot be obtained; e) Non-union of femoral neck or head fractures; and f) Salvage of a failed primary or secondary total or hemi hip.

Source page: https://510kreport.com/device/K971705
Methodology: https://510kreport.com/methodology