Distally Fixed Hip Stem
510(k) K971523
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK971523 | Date1 Oct 1997 | 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- Withdrawn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
- MEH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3353
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 1 Oct 2026
The Distally Fixed Hip Stem is a femoral hip prosthesis classified as a Hip Prosthesis (Device Type MEH) under FDA nomenclature. It is designed for use in revision total hip arthroplasty, providing structural support and stability in cases of bone loss or failed primary implants. Constructed from wrought or forged titanium alloy, the stem features a threaded 12/14 neck trunnion for modular attachment to femoral heads. Its proximal surface is grit-blasted and coated with hydroxylapatite (HA) to enhance osseointegration, while the distal portion is designed for distal fixation within the femoral canal.
This device is supplied sterile and intended for single-use in surgical revision procedures. It is cleared for FDA 510(k) under the Orthopedic advisory committee, with a traditional review pathway. Available in collared and collarless configurations, the stem is compatible with Sulzer femoral heads (e.g., Biolox, Zirconia). Storage and handling must adhere to sterile medical device protocols, and its modular design requires proper alignment during implantation to ensure stability and longevity. No additional regulatory markings beyond the FDA_510K clearance (K971523) are specified.
Other devices from Sulzer Orthopedics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Distally Fixed Hip Stem used for?
The Distally Fixed Hip Stem is specifically designed for revision total hip arthroplasty procedures. It provides structural support and stability in cases where there is significant bone loss or a failed primary hip implant. The distal fixation mechanism ensures secure placement within the femoral canal, while the proximal hydroxylapatite (HA) coating promotes osseointegration for long-term stability.
What material is the stem made from and why?
The stem is constructed from wrought or forged titanium alloy, which offers a balance of strength, durability, and biocompatibility. Titanium is lightweight yet robust enough to withstand the mechanical stresses of hip joint movement, while its corrosion resistance ensures longevity in the body. The use of titanium also reduces the risk of adverse reactions compared to other metals.
Is the Distally Fixed Hip Stem single-use or reusable?
The Distally Fixed Hip Stem is intended for single-use only. This is a standard practice for sterile surgical implants to prevent cross-contamination and ensure patient safety. The device is supplied sterile, and reuse is not recommended or supported by the manufacturer.
What configurations are available for this hip stem?
The Distally Fixed Hip Stem is available in two configurations: collared and collarless. The choice between these depends on the clinical scenario and the surgeon’s preference. The collared version provides additional proximal stability, while the collarless design may offer more flexibility in certain bone conditions or surgical approaches.
How should the Distally Fixed Hip Stem be stored and handled?
The stem must be stored and handled according to sterile medical device protocols to maintain its sterility. It should be kept in its original packaging until immediately before use, protected from contamination, moisture, and physical damage. Proper storage ensures the device remains sterile and functional for its intended single-use surgical procedure.