Biometric Screw Fixation Cup

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

510(k) Number

K922861 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Replica Total Hip System

  Class II

  FDA 510(k) K951741 Active Cleared 7 Aug 1995

• Replica(Tm) Total Hip System

  Class II

  FDA 510(k) K926156 Active Cleared 9 Mar 1994

• Mueller Type Femoral Stem

  Class II

  FDA 510(k) K922864 Active Cleared 12 Feb 1993

• Oti European Compression System

  Class II

  FDA 510(k) K925571 Active Cleared 13 Jul 1993

• Neer Type Shoulder Prosthesis System

  Class II

  FDA 510(k) K922865 Active Cleared 10 Dec 1992

• Unifit Femoral Stem

  Class II

  FDA 510(k) K922871 Active Cleared 12 Feb 1993

See all devices from Osteo Technology, Inc. →

• What is the primary purpose of the Biometric Screw Fixation Cup in orthopedic surgery?

  The Biometric Screw Fixation Cup is designed as a semi-constrained metal acetabular component for hip prostheses. Its purpose is to provide internal fixation within the acetabulum, ensuring stable alignment and even load distribution during hip joint function, which helps maintain the integrity of the hip replacement.

• Is the Biometric Screw Fixation Cup intended for single-use or can it be reused?

  The Biometric Screw Fixation Cup is explicitly described as a reusable medical implant. It is not intended for single-use and is meant to be sterilized and reused in subsequent procedures, though proper sterilization protocols must be followed as per clinical guidelines.

• How is the Biometric Screw Fixation Cup supplied for surgical use?

  The device is supplied in sterile packaging, which is required for clinical application. This ensures it meets regulatory standards for surgical implants before use in orthopedic procedures.

• What regulatory pathway was used for FDA clearance of the Biometric Screw Fixation Cup?

  The Biometric Screw Fixation Cup was cleared through the FDA’s Traditional 510(k) pathway, with clearance number K922861. It was determined to be substantially equivalent to a predicate device and falls under product code JDL for orthopedic hip components.

• Are there multiple sizes or models of the Biometric Screw Fixation Cup available?

  While the provided data does not specify exact sizing details (e.g., diameters, depths, or model variants), the OpenFDA registration numbers indicate multiple FEI (Firm Establishment Identification) entries, suggesting the existence of various sizes or models of the Biometric Screw Fixation Cup. Clinicians should refer to manufacturer documentation for precise sizing options.