# K161233: OXINIUM DH Fermoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 14, 2016 after 226 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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: 5 generations back to K955033 (1996). 47 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners, Smith & Nephew, Inc. (2010) Summary page 4.
- K081566: Smith &  Nephew Oxinium DH Femoral Heads, Smith & Nephew, Inc. (2008) Summary page 4.
- K021673: Total Hip Femoral Head - 12/14 Taper, Smith & Nephew, Inc. (2002) Summary page 4.

## Most influential descendants
- 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
- K243456: ONVOY™ Acetabular System (2025), 0 descendants of its own

## Indications for use
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 or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (iii) for use with or without bone cement.

Source page: https://510kreport.com/device/K161233
Methodology: https://510kreport.com/methodology