Opera Cupflanged Acetabular Components

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991538 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Taylor Spatial Frame External Fixation System

  Class II

  FDA 510(k) K970748 Active Cleared 9 May 1997

• Heidelberg External Fixator

  Class II

  FDA 510(k) K970751 Active Cleared 16 Apr 1997

• Titanium Spinal Rod System

  Class II

  FDA 510(k) K970635 Active Cleared 14 Aug 1997

• Ha Global Taper (Gt) Tapered Hip Stem

  Class II

  FDA 510(k) K970337 Active Cleared 28 Feb 1997

• Profix Plus Tibial Insert, Profix Ps Plus Tibial Insert, Profix P/S Tibial Insert

  Class II

  FDA 510(k) K963255 Active Cleared 2 Jan 1997

• Global Taper Spectron Hip Stems

  Class II

  FDA 510(k) K970351 Active Cleared 28 Feb 1997

See all devices from Smith & Nephew, Inc., Orthopaedic Div. →

• What are the Opera Cupflanged Acetabular Components used for?

  These devices are indicated for use in individuals undergoing primary or revision hip surgery. They are specifically designed to treat hip joints that have been damaged by trauma or noninflammatory degenerative joint disease in cases where other treatment options have failed.

• What material is used to manufacture these acetabular components?

  The Opera Cupflanged Acetabular Components are constructed from all-polyethylene material. This material is utilized to provide the necessary structural support for the acetabulum during hip replacement procedures.

• What is the regulatory status of this device?

  The Opera Cupflanged Acetabular Components are authorized under FDA 510(k) clearance K991538. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.