# K021673: Total Hip Femoral Head - 12/14 Taper

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 11, 2002 after 21 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 8 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081566: Smith &  Nephew Oxinium DH Femoral Heads (2008), 8 descendants of its own
- K161233: OXINIUM DH Fermoral Heads (2016), 6 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own
- K110101: Taper Oxinium Femoral Head (2011), 5 descendants of its own
- K220959: OR3O Dual Mobility System (2022), 3 descendants of its own

## Recalls of this device
- Apr 24, 2024 · Class II · Z-1901-2024: Packaging contained the incorrect size of femoral head from what was displayed on the label.

## 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; hsed hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion; femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K021673
Methodology: https://510kreport.com/methodology