Stryker and Serf hip devices

The Stryker and Serf hip devices are artificial hip replacement components including femoral stems, femoral heads, acetabular shells, liners, and screws that can be combined to form traditional or dual mobility hip systems for primary or revision total hip arthroplasty. They are indicated for treatment of degenerative joint diseases, rheumatoid arthritis, fractures, and revision procedures where previous treatments have failed.

There have been no changes to the technological characteristics, design, or materials of the subject devices compared to the predicate devices. The devices maintain the same composition and sterilization methods as previously cleared versions.

Not stated in this summary. The document references engineering analyses but does not cite specific consensus standards such as ISO, IEC, or ASTM.

Substantial equivalence is claimed based on the same intended use, indications for use, design, materials, sterilization method, and operational principles as the predicate devices. Engineering analyses verified compatibility between Stryker and Serf component combinations through wear testing, impingement analysis, range of motion studies, and MR safety evaluation. Since the devices themselves are unchanged and only labeling was updated to document compatibility between manufacturer components, and the combinations function with equivalent performance characteristics, the devices meet the definition of substantial equivalence.