# K182535: R3 Anteverted Liners

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 19, 2018 after 66 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- 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: 6 generations back to K861766 (1986). 48 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113848: R3 Xlpe Liners, Smith & Nephew, Inc. (2012) Summary page 4.
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners, Smith & Nephew, Inc. (2010) Summary page 4.
- K920430: Modular Acetabular Cup System, Smith & Nephew Richards, Inc. (1992) Summary page 4.
- K102370: R3 Xlpe Anteverted Liners, Smith & Nephew, Inc. (2011) 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
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 R3 Acetabular System is for single use only and is intended for cementless use.

Source page: https://510kreport.com/device/K182535
Methodology: https://510kreport.com/methodology