# K103256: Smith & Nephew SMF Hip Stem

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jan 31, 2011 after 89 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850055 (1985). 22 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 38 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 2.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 2.

## Most influential descendants
- K123012: Smith & Nephew SMF Hip Stem (2012), 10 descendants of its own
- K162775: Legion Cone System (2017), 5 descendants of its own
- K180334: LEGION Knee System (2018), 4 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own

## Recalls of this device
- Feb 19, 2019 · Class II · Z-1028-2019: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
- Feb 19, 2019 · Class II · Z-1029-2019: Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"

## 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. Smith & Nephew SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

Source page: https://510kreport.com/device/K103256
Methodology: https://510kreport.com/methodology