# K162303: REDAPT Sleeved Monolithic Revision Stems

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: May 1, 2017 after 257 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 K850055 (1985). 40 ancestors in all.
4 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)
- K151902: REDAPT¿ Revision Femoral System, Smith & Nephew, Inc. (2015) Summary page 4.
- K121627: Smith & Nephew Redapt Revision Femoral System, Smith & Nephew, Inc. (2012) Summary page 4.
- K081124: MDF Revision Hip System, Smith & Nephew, Inc. (2008) Summary page 4.
- K954935: S-Rom Femoral Hip Stem - Size 14 X 8, Joint Medical Products Corp. (1996) Summary page 4.
- 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 4.
- K042127: Smith & Nephew Modular Hip, Smith & Nephew, Inc. (2004) Summary page 4.
- K052426: Smith & Nephew Modular Hip, Smith & Nephew, Inc. (2005) Summary page 4.

## Most influential descendants
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own
- K231448: TANDEM Hip System (2023), 0 descendants of its own

## Indications for use
The REDAPT Sleeved Monolithic Revision Stems are indicated for: • 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 osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic 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; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The REDAPT™ Revision Hip System (formerly MDF) is intended to be used without cement.

Source page: https://510kreport.com/device/K162303
Methodology: https://510kreport.com/methodology