# K965002: Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and SL and

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Jun 27, 1997 after 193 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 K823727 (1983). 15 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944601: Zimmer Zirconia Ceramic Femoral Head, Zimmer, Inc. (1995) Summary page 1.
- K926395: Elite (TM) Zirconia Total Hip Ball Head System, Depuy, Inc. (1994) Summary page 1.
- K935921: Zirconia Ceramic Femoral Head, Smith & Nephew Richards, Inc. (1994) Summary page 1.

## Most influential descendants
- K990261: Plus Ceramic Head Prostheses (Alumina and Zirkonia) (1999), 9 descendants of its own
- K012918: Apex Modular Alumina Femoral Head (2001), 7 descendants of its own
- K101451: Apex Module Hip System Biolox Delta Femoral Head (2010), 4 descendants of its own
- K201657: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads (2021), 2 descendants of its own
- K241472: Icona Hip Stem (2024), 1 descendant of its own

## Indications for use
The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques.

Source page: https://510kreport.com/device/K965002
Methodology: https://510kreport.com/methodology