# K070756: Smith and Nephew Reflection 3 Acetabular System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 6, 2007 after 78 days
- Product code: MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861766 (1986). 8 ancestors in all.
91 later devices descend from it; 15 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061253: Reflection 3 Acetabular System, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners (2009), 46 descendants of its own
- K100445: Klassic HD Hip System (2010), 25 descendants of its own
- K103721: Mpact Acetabular System (2011), 21 descendants of its own
- K143407: Klassic HD Hip System (2014), 16 descendants of its own
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own

## Recalls of this device
- Apr 22, 2020 · Class II · Z-2332-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells
- Apr 22, 2020 · Class II · Z-2334-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells
- Apr 22, 2020 · Class II · Z-2335-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells
- Apr 22, 2020 · Class II · Z-2336-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells
- Apr 22, 2020 · Class II · Z-2331-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells
- Apr 22, 2020 · Class II · Z-2333-2020: A manufacturing error resulted in out of specification R3 Acetabular Shells

## Indications for use
The Smith & Nephew REFLECTION 3 is indicated for the following: * Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; * Rheumatoid arthritis; * Slipped capital epiphysis; * Fused hip; * Fracture of the pelvis and diastrophic variant; * Old, remote osteomyelitis with an extended drainage-free period; * Revision procedures where other treatments have failed; and * Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; * Femoral osteotomy; * Girdlestone resection; * Fracture dislocation of the hip and; * Correction of deformity The REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.

Source page: https://510kreport.com/device/K070756
Methodology: https://510kreport.com/methodology