AML II Titanium Acetabulum Prosthesis

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K861979 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SN

• Delta Shoulder

  Class II

  FDA 510(k) K021478 Active Cleared 18 Nov 2003

• Synatomic Revision Femoral Prosthesis

  Class II

  FDA 510(k) K860594 Active Cleared 14 Mar 1986

• Porocoat (R) Proximal Femoral Third Prosthesis

  Class II

  FDA 510(k) K872025 Active Cleared 18 Aug 1987

• Cobalt Chrome Gemini

  Class II

  FDA 510(k) K934909 Active Cleared 28 Apr 1994

• Depuy Titanium Cross Pin Fixation System

  Class II

  FDA 510(k) K954630 Active Cleared 13 Dec 1995

• Depuy Cannulated Cross Pin Screw System

  Class II

  FDA 510(k) K963973 Active Cleared 16 Dec 1996

See all devices from Depuy, Inc. →

• What is the AML II Titanium Acetabular Cup Prosthesis used for?

  The AML II Titanium Acetabular Cup Prosthesis is designed specifically for total hip arthroplasty (replacement surgery) to replace a damaged or diseased acetabulum. It serves as the pelvic-side component of the hip joint, providing a stable interface between the femoral prosthesis and the pelvis. Its titanium construction is intended to enhance durability, improve load distribution across the joint, and reduce wear compared to other materials, thereby supporting long-term joint function and patient mobility.

• How is the AML II Titanium Acetabular Cup Prosthesis supplied and intended for use?

  The AML II Titanium Acetabular Cup Prosthesis is supplied sterile and is intended for single-use in orthopedic surgical settings. It must be used under aseptic conditions, following standard protocols for hip arthroplasty. This ensures optimal infection control and maintains the device’s integrity for a single surgical procedure.

• Is the AML II Titanium Acetabular Cup Prosthesis reusable or single-use?

  The AML II Titanium Acetabular Cup Prosthesis is explicitly designed for single-use only. Its sterile packaging and surgical-grade titanium construction are optimized for one-time implantation during hip replacement surgery. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device performance.

• What regulatory clearance does the AML II Titanium Acetabular Cup Prosthesis hold?

  The AML II Titanium Acetabular Cup Prosthesis holds FDA 510(k) clearance under the reference number K861979. This clearance was granted under the Orthopedic advisory committee classification, indicating its substantial equivalence for certain indications in hip replacement procedures. Compliance with FDA guidelines and institutional policies is required for its use.

• How should the AML II Titanium Acetabular Cup Prosthesis be stored before use?

  The AML II Titanium Acetabular Cup Prosthesis should be stored in its original sterile packaging, protected from moisture, contamination, and physical damage. It must remain in a clean, controlled environment (e.g., operating room or sterile storage area) until immediately before use. Always follow the manufacturer’s storage instructions to preserve sterility and device integrity.