# K081566: Smith &  Nephew Oxinium DH Femoral Heads

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 21, 2008 after 78 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955033 (1996). 8 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 17 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.
- K022958: Total Hip Femoral Heads and Liners, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K161233: OXINIUM DH Fermoral Heads (2016), 6 descendants of its own
- K191002: OR3O Dual Mobility System (2019), 5 descendants of its own
- K220959: OR3O Dual Mobility System (2022), 3 descendants of its own
- K232667: OR3O Dual Mobility Liners (2023), 1 descendant of its own
- K253948: Momentum Acetabular Cup System (2026), 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; old, remote osteomyelitis with an extended drainage-free period; 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. Smith & Nephew Oxinium DH femoral heads are for single use only.

Source page: https://510kreport.com/device/K081566
Methodology: https://510kreport.com/methodology