# K042127: Smith & Nephew Modular Hip

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 19, 2004 after 105 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: 3 generations back to K935452 (1994). 12 ancestors in all.
17 later devices descend from it; 5 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)
- K921111: S-Rom Zirconia Cermamic Femoral Head, Joint Medical Products Corp. (1992) Summary page 1.
- K934412: Coated ZT Proximal Sleeve, Joint Medical Products Corp. (1994) Summary page 1.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 1.
- K961939: S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115), Johnson & Johnson Professionals, Inc. (1996) Summary page 1.
- K963509: Global Taper Tapered Hip System, GT Spectron, Smith & Nephew Richards, Inc. (1997) Summary page 1.
- K991485: Synergy Porous Size 8 Hip Stem, Smith & Nephew, Inc. (1999) Summary page 1.
- K002996: Synergy HA Coated Porous Femoral  Stems, Smith & Nephew, Inc. (2000) Summary page 1.

## Most influential descendants
- K081124: MDF Revision Hip System (2008), 14 descendants of its own
- K113789: Modular Proximally Fluted Hip Stem (2012), 8 descendants of its own
- K151902: REDAPT¿ Revision Femoral System (2015), 7 descendants of its own
- K052426: Smith & Nephew Modular Hip (2005), 6 descendants of its own
- K121627: Smith & Nephew Redapt Revision Femoral System (2012), 5 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; old, remote osteomyelitis with an extended drainage-free period; 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 Modular Hip components are for single use only.

Source page: https://510kreport.com/device/K042127
Methodology: https://510kreport.com/methodology