# K033442: Reflection Constrained Liner

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Nov 26, 2003 after 28 days
- Product code: KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
65 later devices descend from it; 6 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Reflection Constrained Liner (28 mm): named in the summary without a submission number
- (no number) Reflection Acetabular Component: named in the summary without a submission number
- (no number) Johnson & Johnson S-Rom Poly-Dial Constrained Liner: named in the summary without a submission number
- (no number) Osteonics Constrained Acetabular Insert: named in the summary without a submission number
- (no number) Zimmer Triology Acetabular System: named in the summary without a submission number

## Most influential descendants
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own

## Indications for use
The Reflection Constrained Liner is a cemented or uncemented prosthesis intended to replace a hip joint. The Reflection Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, and intra-operative instability and for whom all other options to constrained acetabular components have been considered. The components subject of this notification are to be used with the Reflection Acetabular System, which is indicated for use with or without cement, and includes single use devices.

Source page: https://510kreport.com/device/K033442
Methodology: https://510kreport.com/methodology