# K113789: Modular Proximally Fluted Hip Stem

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 19, 2012 after 119 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: 1 (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). 36 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081124: MDF Revision Hip System, Smith & Nephew, Inc. (2008) Summary page 1.

## Most influential descendants
- K151902: REDAPT¿ Revision Femoral System (2015), 7 descendants of its own
- K162303: REDAPT Sleeved Monolithic Revision Stems (2017), 4 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K243021: Longboard Revision Hip Stem (2025), 0 descendants of its own

## Recalls of this device
- Nov 15, 2016 · Class II · Z-0945-2017: All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.

## Indications for use
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 or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthrilis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diasirophic variant- Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endloprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Source page: https://510kreport.com/device/K113789
Methodology: https://510kreport.com/methodology