# K972792: Duration Stabilized Uhmwpe Acetabular Components

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Oct 16, 1997 after 80 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
Longest line of descent: 1 generation back to K855231 (1986). 3 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936132: Exeter All Plastic Acetabular Component, Howmedica, Inc. (1994) Summary page 1.
- K855231: Howmedica Bipolar Prosthesis, Howmedica Corp. (1986) Summary page 1.
- K934060: Howmedica (R) Acetabular Comp Pack/Manuf Meth Change, Howmedica Corp. (1995) Summary page 1.

## 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 Exeter All Plastic Acetabular Component (previously cleared in K936132) is intended to be used for primary and secondary reconstruction of the bearing surface of the acetabulum as a result of painful and/or severly disabled hip joints due to osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or revision of a failed acetabular component. The Howmedica® Bipolar Prosthesis, Centrax® (previously cleared in K855231) is intended to be used in conjunction with a femoral stem component for the reconstruction of a femoral head damaged by fresh fracture, non-union, aseptic necrosis of the head and neck, or by osteoarthritis or post-traumatic arthritis.

Source page: https://510kreport.com/device/K972792
Methodology: https://510kreport.com/methodology