# K962541: Reflection Acetabular Reinforcement Rings

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Sep 17, 1996 after 81 days
- Product code: JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 5 cite it directly.
0 of 10 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) Trilogy™ Acetabular System - Zimmer: named in the summary without a submission number
- (no number) Porous Ringloc Acetabular System - Biomet: named in the summary without a submission number
- (no number) S-ROM™ Oblong Component - Joint Medical Products Corporation: named in the summary without a submission number
- (no number) MARS® Ringloc Component - Biomet: named in the summary without a submission number
- (no number) Healey Flanged Component - Biomet: named in the summary without a submission number
- (no number) Original M.E. Miiller Acetabular Roof Reinforcement Ring - Protek Ltd.: named in the summary without a submission number
- (no number) H.B. Burch- R. Schneider Reinforcement Cage: named in the summary without a submission number
- (no number) R. Ganz Acetabular Roof Reinforcement Ring with Hook - Intermedics: named in the summary without a submission number
- (no number) Gap Acetabular Cup - Osteonics: named in the summary without a submission number
- (no number) Oh-Harris Protrusio Shell - Howmedica: named in the summary without a submission number

## Most influential descendants
- K040680: Contour HA Coated Reconstruction Ring (2004), 6 descendants of its own
- K171073: Smith & Nephew, Inc. REDAPT Augments (2017), 5 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K092098: Patient Specific Acetabular Reconstruction Prosthesis (2010), 1 descendant 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

## Indications for use
The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.

Source page: https://510kreport.com/device/K962541
Methodology: https://510kreport.com/methodology