HC 1M Metalbacked Acetabular Cup

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

510(k) Number

K823419 ↗

FDA Product Code

JDI

Device Class

Class II

Regulation

21 CFR Part 888.3350

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. →

• What is the HC 1M Metalbacked Acetabular Cup used for?

  The HC 1M Metalbacked Acetabular Cup is a prosthesis designed for use in hip replacement surgery. It is a semi-constrained, metal/polymer device that is cemented in place during orthopedic procedures to replace the natural acetabulum.

• Is the HC 1M Metalbacked Acetabular Cup reusable or single-use?

  This device is supplied as a single-use implant only. It is not designed to be reused and should be discarded after one surgical procedure. Additionally, it is not MRI safe due to its metal components.

• What regulatory status does the HC 1M Metalbacked Acetabular Cup have?

  The HC 1M Metalbacked Acetabular Cup has FDA 510(k) clearance with the product code JDI, classified as a Class II medical device. It received clearance on January 17, 1983, and is considered substantially equivalent to other devices on the market.

• How should the HC 1M Metalbacked Acetabular Cup be stored?

  The device should be stored according to the manufacturer's specifications. While the exact storage conditions aren't detailed in the provided information, medical implants typically require storage in a controlled environment to maintain sterility and integrity until use.