Acetabular Dome Hole Plugs

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

510(k) Number

K942809 ↗

FDA Product Code

JDL

Device Class

Class III

Regulation

21 CFR Part 888.3320

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Osteonics(R) Omnifit(R) Normalized Hip Stem

  Class II

  FDA 510(k) K932519 Active Cleared 10 Mar 1994

• Omnifit II Hip Prostheses: Cement Fixation

  Class II

  FDA 510(k) K870235 Active Cleared 29 May 1987

• Osteonics Total Elbow System Open recall

  Class II

  FDA 510(k) K980502 Active Cleared 5 May 1998

• MC2P Acetabular Component Open recall

  Class II

  FDA 510(k) K900438 Active Cleared 18 Apr 1990

• Shoulder Microstructured Humeral Prosthesis

  Class II

  FDA 510(k) K883816 Active Cleared 10 Nov 1988

• Osteonics(R) Mpss Hip Stem Series

  Class II

  FDA 510(k) K905275 Active Cleared 28 Jan 1991

See all devices from Osteonics Corp. →

• Are these hole plugs intended for single-use or can they be reused in multiple procedures?

  The Acetabular Dome Hole Plugs are explicitly described as reusable medical devices, meaning they are designed to be used in multiple surgical procedures after proper cleaning and sterilization between cases. This classification aligns with their intended use in orthopedic settings where durability and repeated application are required.

• What sizes or models are available for these acetabular dome hole plugs, and how are they differentiated?

  The data lists multiple FEI numbers (e.g., 3020282716, 1047843, etc.) associated with these hole plugs, which typically correspond to distinct sizes or variations in design. While the exact dimensions or model names aren’t specified, the presence of numerous FEI numbers suggests a range of sizes to accommodate different acetabular component perforations or screw holes. For precise sizing, refer to the manufacturer’s catalog or technical documentation.

• How are these hole plugs regulated in the U.S., and what does the FDA clearance indicate about their safety and effectiveness?

  These hole plugs are regulated under the FDA 510(k) clearance process (K942809) and fall under product code JDL, classified as Class III orthopedic devices. The clearance indicates that the manufacturer has demonstrated the device is substantially equivalent to a legally marketed predicate, meaning it meets the same safety and performance standards as an existing, approved device. This does not imply new clinical breakthroughs but confirms compliance with regulatory requirements for use in hip replacement surgeries.

• Are these hole plugs compatible with MRI imaging, and what should clinicians consider regarding their use?

  The provided data does not mention MRI safety for the Acetabular Dome Hole Plugs, meaning no information is available to confirm or deny their compatibility with MRI imaging. Clinicians should consult the manufacturer’s instructions or additional documentation to assess potential risks (e.g., metal artifacts, heating) before using these devices in patients who may require MRI scans post-surgery. Always verify compatibility with the specific MRI system in use.