# K022958: Total Hip Femoral Heads and Liners

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 2, 2002 after 26 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955033 (1996). 6 ancestors in all.
162 later devices descend from it; 6 cite it directly.
0 of 169 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads, Sulzer Orthopedics, Inc. (2000) Summary page 1.
- K003391: Osteonics Alumina C-Taper Head, Howmedica Osteonics Corp. (2000) Summary page 1.
- K002575: Inter-OP Durasul Acetabular Inserts (4MM), Sulzer Orthopedics, Inc. (2000) Summary page 1.
- K010171: Duraloc Acetabular Cup System, 36MM Marathon +4 Polyethylene Liner, DePuy Orthopaedics, Inc. (2001)
- (no number) Currently marketed heads distributed by Smith & Nephew: named in the summary without a submission number
- (no number) Smith & Nephew crosslinked polyethylene liners: named in the summary without a submission number

## Most influential descendants
- K083762: Biolox Delta Ceramic Femoral Heads (2009), 149 descendants of its own
- K100412: Biolox Delta Ceramic Femoral Heads (2010), 140 descendants of its own
- K103120: Corin Biolox Delta Femoral Heads (2011), 110 descendants of its own
- K110087: Corin Trinity Acetbular System with Hxlpe Liners (2011), 109 descendants of its own
- K111911: Corin Optimom Modular Head (2011), 62 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; 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 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/K022958
Methodology: https://510kreport.com/methodology