# K090982: Smith & Nephew Hip Systems with HA

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 21, 2010 after 379 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- 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: 1 generation back to K970337 (1997). 5 ancestors in all.
24 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)
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 1.
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 2.
- K970337: HA Global Taper (GT) Tapered Hip Stem, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 2.
- K990666: Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell, Smith & Nephew, Inc. (1999) Summary page 2.
- K022556: Reflection Modified Acetabular Shells, Smith & Nephew, Inc. (2002) Summary page 1.

## Most influential descendants
- K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite (2011), 22 descendants of its own
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own
- K163577: Ecofit® Hip System (2017), 9 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. Smith & Nephew Hip System components with HA are intended for single use only and are intended to be implanted without bone cement.

Source page: https://510kreport.com/device/K090982
Methodology: https://510kreport.com/methodology