# K955117: Implex Ceramic Head

- Pathway: 510(k) (Traditional)
- Applicant: Implex Corp.
- Decided: Apr 5, 1996 after 148 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: 1 generation back to K925345 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925345: Ziconia Ceramic Mod Head (Type I Taper 28/32, +6MM), Biomet, Inc. (1994) Summary page 1.
- K952418: V40 Zirconia Femoral Heads, Howmedica Corp. (1995) Summary page 1.
- K946026: Howmedica (R) 28MM Zirconia Femoral Heads, Howmedica, Inc. (1995) Summary page 1.
- (no number) PROZYR™ Zirconium Oxide Ceramic Head from Smith & Nephew Richards, Inc.: named in the summary without a submission number
- (no number) Ceramic Bearing Head from Osteonics, Corp.: named in the summary without a submission number

## Indications for use
The Implex Ceramic Head is intended to provide articulation in cases of: Severely disabled joints as a result of degenerative arthritis or avascular NECrosis. Secondary revision of a previously unsuccessful femoral component or total hip replacement. Other hip problems where clinical experience has shown that alternative modes of treatment are less likely to achieve satisfactory results. Fracture dislocation of the hip or irreducible fractures in which adequate fixation cannot be obtained. Non-union of femoral neck or head fractures. Salvage of a failed primary or secondary total or hemi hip. The Implex Ceramic Head is intended to be used in either cemented or uncemented applications depending on the intended use of the femoral stem it is mated with.

Source page: https://510kreport.com/device/K955117
Methodology: https://510kreport.com/methodology