# K181366: REDAPT Porous Acetabular Shell

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Sep 24, 2018 after 124 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: 11 generations back to K810258 (1981). 75 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150790: REDAPT Porous Acetabular Shell and Cemented Liner, Smith & Nephew, Inc. (2015) Summary page 4.
- K110135: Polarcup Dual Mobility System, Smith & Nephew, Inc. (2011) Summary page 4.
- K150522: G7 Dual Mobility System, Biomet, Inc. (2015) Summary page 4.
- K072121: Trabecular Metal Acetabular Revision System Cemented Contrained Liner, Zimmer, Inc. (2008) Summary page 4.

## Most influential descendants
- K242744: Trinity EVO Acetabular Shell (2025), 0 descendants of its own

## Indications for use
Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis. Fracture or avascular necrosis of the femoral head Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement All forms of osteoarthritis Patients with hips at risk of dislocation Femoral neck fracture or proximal fracture to hip joint The REDAPT Porous Acetabular Shell for use with the POLACUP Dual Mobility System is intended for single use only and is to be implanted without bone cement. The POLARCUP Dual Mobility System is to be implanted in the REDAPT Porous Acetabular Shell with bone cement.

Source page: https://510kreport.com/device/K181366
Methodology: https://510kreport.com/methodology