# K060630: Reflection 3-Hole Shell with Asymmetric Porous Coating

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 14, 2006 after 97 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- 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
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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: named in the summary without a submission number

## Most influential descendants
- K092098: Patient Specific Acetabular Reconstruction Prosthesis (2010), 1 descendant of its own
- K201701: R3 HA Coated Acetabular Shells (2020), 0 descendants of its own
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The REFLECTION 3-Hole Shell with Asymmetric Porous Coating is 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; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; 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. The REFLECTION 3-Hole Shell with asymmetric porous coating is for single use only

Source page: https://510kreport.com/device/K060630
Methodology: https://510kreport.com/methodology