# K201701: R3 HA Coated Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 6, 2020 after 106 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: 5 generations back to K861766 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060630: Reflection 3-Hole Shell with Asymmetric Porous Coating, Smith & Nephew, Inc. (2006) Summary page 4.
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 4.
- K070756: Smith and Nephew Reflection 3 Acetabular System, Smith & Nephew, Inc. (2007) Summary page 4.
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners, Smith & Nephew, Inc. (2009) Summary page 4.
- K090982: Smith & Nephew Hip Systems with HA, Smith & Nephew, Inc. (2010) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K201701
Methodology: https://510kreport.com/methodology