# K081124: MDF Revision Hip System

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jul 31, 2008 after 101 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K850055 (1985). 35 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042127: Smith & Nephew Modular Hip, Smith & Nephew, Inc. (2004) Summary page 1.
- K072417: Smith & Nephew Mis Hip Stem, Smith & Nephew, Inc. (2008) Summary page 1.
- K052792: Anthology Hip Stem, Smith & Nephew, Inc. (2005) Summary page 1.
- K963486: Revision Hip System, Smith & Nephew Richards, Inc. (1996) Summary page 1.

## Most influential descendants
- K113789: Modular Proximally Fluted Hip Stem (2012), 8 descendants of its own
- K151902: REDAPT¿ Revision Femoral System (2015), 7 descendants of its own
- K121627: Smith & Nephew Redapt Revision Femoral System (2012), 5 descendants of its own
- K100481: Smith & Nephew MDF Modular Sleeve (2010), 5 descendants of its own
- K162303: REDAPT Sleeved Monolithic Revision Stems (2017), 4 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.
- Aug 22, 2012 · Class II · Z-2427-2012: Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

## 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 osteomyelitits 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 MDF Hip System components are intended for single use only and are to be implanted without bone cement.

Source page: https://510kreport.com/device/K081124
Methodology: https://510kreport.com/methodology