# K991026: Reflection Crosslinked Uhmwpe Acetabular Components

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 22, 1999 after 207 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 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 no predicate by number.

## Most influential descendants
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own
- K160895: Initia Total Hip System & BIOCERAM AZUL (R) HEAD (2016), 2 descendants of its own
- K221149: U-Motion II Acetabular System-Extension line (2023), 1 descendant of its own
- K253948: Momentum Acetabular Cup System (2026), 0 descendants of its own

## Recalls of this device
- Nov 21, 2008 · Not classified · Z-1004-2009: Liners measuring 28 mm ID and were mismarked as 32 mm.

## 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/K991026
Methodology: https://510kreport.com/methodology