Acetabular Dome and Screw Hole Plugs

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

510(k) Number

K920868 ↗

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 acetabular dome and screw hole plugs designed for single-use or can they be reused in multiple procedures?

  These devices are explicitly labeled as reusable medical devices in the provided data. They are intended for use across multiple procedures, provided they are properly cleaned, sterilized, and maintained according to manufacturer guidelines. This reuse classification is consistent with their classification as Class III devices under FDA regulation 888.3320.

• What types of hip procedures are these components typically used in, and how do they improve stability?

  The Acetabular Dome and Screw Hole Plugs are designed for hip replacement surgery, specifically to reinforce the acetabular dome and fill screw holes in hip prostheses. They are semi-constrained metal cemented acetabular components, meaning they provide structural reinforcement to ensure stability during both primary hip arthroplasty and revision procedures. By filling screw holes and reinforcing the dome, they help maintain the integrity of the acetabular component, reducing the risk of loosening or failure.

• How many different model variants are available, and how can I identify them?

  The device data lists multiple registration numbers and FEI numbers (e.g., 3020282716, 3007923096, etc.) corresponding to different model variants. These identifiers are used to distinguish between specific sizes, designs, or configurations of the acetabular dome and screw hole plugs. To identify a particular variant, you would reference the FEI number or registration number associated with the device in your inventory or order.

• What regulatory pathway was followed for FDA clearance, and what does this mean for my facility?

  The Acetabular Dome and Screw Hole Plugs received FDA 510(k) clearance (K920868) under the Traditional 510(k) Review pathway, with a decision date of May 26, 1992. This means the device was determined to be substantially equivalent to a legally marketed predicate device (a previously cleared hip prosthesis). For your facility, this clearance confirms the device meets FDA safety and effectiveness standards for use in orthopedic settings, though you should always verify compliance with current FDA guidelines and institutional protocols.