# K113039: Smith & Nephew Radiopaque Trial Necks

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 5, 2012 after 359 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: 8 generations back to K911686 (1991). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080625: Smith & Nephew Mis Hip Stem with Stiktite, Smith & Nephew, Inc. (2008) Summary page 1.
- K081124: MDF Revision Hip System, Smith & Nephew, Inc. (2008) Summary page 1.
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K132435: Smith & Nephew Global Femoral Head Trials (2013), 0 descendants of its own

## Indications for use
Total hip components are indicated for uncemented use in 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.

Source page: https://510kreport.com/device/K113039
Methodology: https://510kreport.com/methodology