# K970337: HA Global Taper (GT) Tapered Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Feb 28, 1997 after 30 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
No predicates in its family tree.
83 later devices descend from it; 6 cite it directly.
0 of 84 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
- K050849: HA Coated Lag Screw (2005), 34 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own
- K090982: Smith & Nephew Hip Systems with HA (2010), 24 descendants of its own
- K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite (2011), 22 descendants of its own

## Indications for use
The HA Global Taper (GT) Tapered Hip Stem is made of metal alloys. The components are indicated for uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for 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. Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K970337
Methodology: https://510kreport.com/methodology