# K013658: Modification to Reflection Cross-Linked Uhmwpe Acetabular Components

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 5, 2001 after 29 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
Longest line of descent: 1 generation back to K002747 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002747: Reflection Cross-Linked Uhmwpe Acetabular Components, Smith & Nephew, Inc. (2000) Summary page 1.
- (no number) Zirconia Ceramic Femoral Heads: named in the summary without a submission number

## Most influential descendants
- K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD (2016), 2 descendants of its own
- K242045: Initia T3 Acetabular Hemispherical Shell System (2025), 0 descendants of its own
- K243444: Bioceram Azul® Head (2024), 0 descendants of its own

## Indications for use
Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

Source page: https://510kreport.com/device/K013658
Methodology: https://510kreport.com/methodology