DePuy CAS Hemi ASR Hip Instruments
510(k) K071334
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK071334 | Date2 Jul 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DePuy CAS Hemi ASR Hip Instruments are classified as stereotaxic instruments, designed for precise positioning of components during hip arthroplasty procedures. These instruments are used in conjunction with the ASR Hemi hip system to facilitate accurate alignment and fixation of prosthetic components in the femoral head and acetabulum. The device includes calibrated tools to ensure proper placement and stability of the implant during surgery. Its design supports minimally invasive techniques while maintaining structural integrity and functional performance.
These instruments are supplied sterile for single-use and are intended for use in orthopedic surgical settings. They are regulated under FDA 510(k) clearance (K071334) and fall under product code HAW, classified as Class II with special controls. No additional sterility or MRI safety information is specified, and the instruments are not intended for reuse. Compliance with FDA guidelines ensures adherence to performance standards for stereotaxic instruments in orthopedic applications.
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the DePuy CAS Hemi ASR Hip Instruments?
The DePuy CAS Hemi ASR Hip Instruments are designed as stereotaxic tools specifically for hip arthroplasty procedures. They facilitate precise alignment and secure fixation of prosthetic components in the femoral head and acetabulum, supporting minimally invasive techniques while maintaining structural integrity during surgery.
Are these instruments intended for reuse or single-use?
These instruments are supplied sterile and explicitly intended for single-use only. The manufacturer emphasizes this to ensure patient safety and device performance, as reuse could compromise sterility and accuracy.
What regulatory pathway does the DePuy CAS Hemi ASR Hip Instruments follow?
The instruments are regulated under the FDA 510(k) clearance process, classified as substantially equivalent to a predicate device. They fall under product code HAW and are categorized as Class II with special controls, ensuring compliance with performance standards for orthopedic stereotaxic instruments.
How are these instruments supplied, and what does that imply for surgical planning?
The instruments are supplied sterile in a pre-packaged format, ready for immediate use in the operating room. This eliminates the need for additional sterilization steps, streamlining workflow and reducing surgical preparation time while maintaining aseptic conditions.
What type of surgical procedures are these instruments intended for?
These instruments are intended exclusively for use in hip arthroplasty procedures, specifically for the ASR Hemi hip system. They are engineered to assist surgeons in achieving accurate component placement and fixation, critical for restoring function and stability in patients undergoing hip replacement surgery.