# K991538: Opera Cupflanged Acetabular Components

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew, Inc., Orthopaedic Div.
- Decided: Jun 3, 1999 after 31 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- 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) Spectron All-Polyethylene Acetabular Component: named in the summary without a submission number
- (no number) Depuy OGEE® Flanged Acetabular Cup: named in the summary without a submission number
- (no number) Depuy All-Polyethylene Cemented Acetabular Cup: named in the summary without a submission number

## Most influential descendants
- K123598: Smith & Nephew, Inc. Hip System Instrumentation (2013), 0 descendants of its own

## Indications for use
The Opera Cup 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) of any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. It is 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 heads involvement that are unmanageable using other techniques, endoprosthesis, femoral osteotomy, or Girdlestone resection fracture-dislocation of the hip: and correction of deformity.

Source page: https://510kreport.com/device/K991538
Methodology: https://510kreport.com/methodology