# K963940: Exeter Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica, Inc.
- Decided: Feb 13, 1997 after 135 days
- Product code: JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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 K890450 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925883: Osteonics Microstructured Acetabular Components, Osteonics Corp. (1993) Summary page 1.
- K890450: Intermedics Apr (TM) II Femoral Component, Intermedics Orthopedics (1989) Summary page 1.
- (no number) Howmedica's Acetabular mesh (preamendment): named in the summary without a submission number

## Indications for use
The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required. The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.

Source page: https://510kreport.com/device/K963940
Methodology: https://510kreport.com/methodology