# K012787: Vaporized Hydrogen Peroxide (VHP) Sterilization of Uhmwpe Components in the Reflection Actabular System (Acetabular Line

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 15, 2002 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 System: named in the summary without a submission number

## Most influential descendants
- K053338: Arthrex Titanium and Bio-Degradable (Polymer) Implants (2006), 0 descendants of its own

## Recalls of this device
- Nov 25, 2013 · Class II · Z-0581-2014: One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

## 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; 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 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. When used in combination with an appropriately sized Reflection metal acetabular shell, Reflection Acetabular Liners are intended for cemented or uncemented use. Reflection All Polyethylene Cups are intended for cemented use only. Reflection Acetabular Liners and All Polyethylene Cups are intended for single use only. The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Reflection Acetabular System (i.e. acetabular liners and all polyethylene cups)

Source page: https://510kreport.com/device/K012787
Methodology: https://510kreport.com/methodology