Compress Anti-Rotation Spindles

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

510(k) Number

K101475 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Comprehensive® Convertible Glenoid - Vivacit-E Liner

  Class II

  FDA 510(k) K211729 Active Cleared 4 Nov 2021

• Modular Hybrid Glenoid

  Class II

  FDA 510(k) K060694 Active Cleared 11 Dec 2006

• Altra Press-Fit Hip System

  Class III

  FDA 510(k) K063002 Active Cleared 31 Oct 2006

• Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits

  Class II

  FDA 510(k) K141219 Active Cleared 18 Jul 2014

• Biomet Headless Compression and Twist-off Screws

  Class II

  FDA 510(k) K142658 Active Cleared 13 Nov 2014

• ExpressBraid Graft Manipulation

  Class II

  FDA 510(k) K152868 Active Cleared 8 Feb 2016

See all devices from Biomet Manufacturing Corp →

• Are these spindles designed for single-use or can they be reused in multiple procedures?

  The Compress Anti-Rotation Spindles are explicitly labeled as reusable medical devices. They are intended for use in multiple procedures after proper sterilization between uses, as required for reusable orthopedic implants.

• How are these spindles sterilized before use, and what are the recommended storage conditions?

  The spindles are not sterile at the time of shipment and must be sterilized prior to surgical use. While the data does not specify sterilization methods, reusable orthopedic implants like these typically require terminal sterilization (e.g., ethylene oxide or autoclave) before use. Storage should follow manufacturer guidelines for sterilized reusable devices, ensuring they remain clean, dry, and protected from contamination until use.

• What sizes or configurations are available for these spindles, and how do I identify them?

  Multiple sizes and configurations are available, each identified by a unique FEI number (e.g., 3020282716, 3007923096, etc.). These numbers correspond to specific spindle designs, and the full list is provided in the regulatory data. Contact Biomet Manufacturing Corp for detailed specifications on each FEI number or refer to their technical documentation.

• Are these spindles intended for use in any specific type of hip arthroplasty procedure?

  The Compress Anti-Rotation Spindles are designed for use in uncemented hip prostheses, specifically to stabilize the femoral head within the acetabular cup and reduce rotational movement. They are not indicated for cemented procedures or other types of joint replacements, such as knee or shoulder arthroplasty.

• What regulatory pathway was followed for clearance of these spindles, and how can I verify their compliance?

  These spindles were cleared through the FDA’s 510(k) pathway under clearance number K101475, classified as a Class III orthopedic implant. Compliance is governed under regulation number 888.3330, and the device is listed under the product code KWA for semi-constrained metal acetabular components. For verification, you can reference the FDA’s openFDA database or contact Biomet Manufacturing Corp for official documentation.