# K993889: Exeter Ceramic Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Feb 11, 2000 after 87 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920577 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972361: V40 Zirconia Femoral Heads, Howmedica, Inc. (1997) Summary page 1.
- K891454: Exeter II Total Hip System, Howmedica Corp. (1989) Summary page 1.

## Indications for use
The Exeter Ceramic Femoral Heads are intended to be used with modular femoral components in primary and secondary cemented or cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis. The Exeter Ceramic Femoral Heads are intended to be used with the femoral components of the previously released Exeter hip stems - and Exeter II Total Hip System (K891454).

Source page: https://510kreport.com/device/K993889
Methodology: https://510kreport.com/methodology