# K990666: Hydroxyapatite (HA) Reflection Acetabular Shell, Hydroxyapatite (HA) Reflection Interfit Shell

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 6, 1999 after 157 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
125 later devices descend from it; 5 cite it directly.
0 of 126 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 Acetabular Shell - Smith & Nephew, Inc.: named in the summary without a submission number
- (no number) Reflection InterFit Acetabular Shell - Smith & Nephew, Inc.: named in the summary without a submission number
- (no number) Osteonics® SecurFit™ HA Hydroxylapatite Coated Shell: named in the summary without a submission number
- (no number) Osteonics® Normalized AD-HA Acetabular Component System: named in the summary without a submission number
- (no number) Osteonics® HA Generation II Acetabular Component System: named in the summary without a submission number
- (no number) Osteonics® Restoration HA Hip Stems: named in the summary without a submission number
- (no number) APR Porous HA Hip Stem - Sulzer Orthopedics, Inc.: named in the summary without a submission number

## Most influential descendants
- K061253: Reflection 3 Acetabular System (2006), 120 descendants of its own
- K070756: Smith and Nephew Reflection 3 Acetabular System (2007), 91 descendants of its own
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners (2009), 46 descendants of its own
- K100933: Consensus CS2 Plus Acetabular Insert (2010), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own

## Recalls of this device
- Jul 6, 2016 · Class II · Z-2297-2016: The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.

## Indications for use
Total hip components are indicated for individuals undergoing primary or 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 eiphysis, fused hip, fracture of the pelvcis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteoeomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K990666
Methodology: https://510kreport.com/methodology