# K935921: Zirconia Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Nov 28, 1994 after 376 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 K823727 (1983). 12 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854791: Bio-Fit Hip System, Richards Medical Co., Inc. (1986) Summary page 2.
- K860635: Opti-Fix Total Hip System, Richards Medical Co., Inc. (1986) Summary page 2.
- K921400: Hip Joint Prothesis, Smith & Nephew Richards, Inc. (1993) Summary page 2.
- K823727: Spectron Primary Stem Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 2.
- K823722: Spectron Long, Straight Femoral Prosthes, Richard'S Medical Equip., Inc. (1983) Summary page 2.
- K881117: Resubmitting of HJD Total Hip System, Richards Medical Co., Inc. (1988) Summary page 2.
- K873797: TI-Fit Total Hip System, Richards Medical Co., Inc. (1987) Summary page 2.
- K870128: Hartford Total Hip System (Tri-Wedge), Richards Medical Co., Inc. (1987) Summary page 2.
- K862225: International Total Hip System, Richards Medical Co., Inc. (1986) Summary page 2.
- K900628: Modular Hip System, Richards Medical Co., Inc. (1990) Summary page 2.
- K912593: Modular Hip System, Smith & Nephew Richards, Inc. (1991) Summary page 2.
- K923275: RMHS Monolithic Femoral Component, Smith & Nephew Richards, Inc. (1993) Summary page 2.

## Most influential descendants
- K965002: Zirconia Ceramic Femoral Heads with Foundation Forged, Textured and Porous Stems, the Encore Vitality Stems and SL and (1997), 10 descendants of its own
- 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

Source page: https://510kreport.com/device/K935921
Methodology: https://510kreport.com/methodology