# K110101: Taper Oxinium Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 11, 2011 after 88 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: 5 generations back to K861766 (1986). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 1.
- K072817: Echelon Titanium Hip System, Smith & Nephew, Inc. (2008) Summary page 1.
- K022902: Smith & Nephew Hip System, Smith & Nephew, Inc. (2002) Summary page 1.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 1.
- K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own
- K231448: TANDEM Hip System (2023), 0 descendants of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. The subject devices are intended for single use only.

Source page: https://510kreport.com/device/K110101
Methodology: https://510kreport.com/methodology