# K150790: REDAPT Porous Acetabular Shell and Cemented Liner

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 16, 2015 after 236 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K861766 (1986). 10 ancestors in all.
13 later devices descend from it; 7 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050937: Trabecular Metal Acetabular Revision Shells, Zimmer Trabecular (2005) Summary page 5.
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 5.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 5.

## Most influential descendants
- K171073: Smith & Nephew, Inc. REDAPT Augments (2017), 5 descendants of its own
- K182109: REDAPT Modular Acetabular Shell (2018), 4 descendants of its own
- K160923: REDAPT Anteverted Cemented Liner (2016), 4 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K210614: BENCOX Mirabo Z Cup Cortinium (2022), 1 descendant of its own

## Indications for use
The REDAPT Porous Acetabular Shell and Cemented Liner 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 Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.

Source page: https://510kreport.com/device/K150790
Methodology: https://510kreport.com/methodology