Micro-Struc Acetabular Component MC2P

• • Ongoing Z-3196-2026 FDA Class II ·initiated 30 Jul 2026

  Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

Full name

Micro-Struc. Acetabular Compon- MC2P

510(k) Number

K850352 ↗

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. →

• What types of patients is the Micro-Struc Acetabular Component MC2P designed for, and how does its semi-constrained design benefit them?

  The Micro-Struc Acetabular Component MC2P is designed for patients undergoing total hip arthroplasty who require replacement of a damaged or diseased acetabulum. Its semi-constrained design provides enhanced stability while preserving mobility, making it particularly suitable for patients who need a balance between joint stability and range of motion during reconstruction.

• Is the Micro-Struc Acetabular Component MC2P intended for single-use or reusable applications, and how should it be fixed in place?

  The Micro-Struc Acetabular Component MC2P is explicitly designed as a reusable device. It is intended for cemented fixation within the pelvis, meaning it is secured in place using bone cement during orthopedic surgery.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical settings?

  The Micro-Struc Acetabular Component MC2P received FDA 510(k) clearance through the Traditional pathway, which means it was determined to be substantially equivalent to a legally marketed predicate device. This clearance allows it to be used in clinical settings for its intended purpose—replacing the acetabulum in total hip arthroplasty—while adhering to FDA Class III regulatory standards for hip prostheses.

• Are there specific sizes or models available for the Micro-Struc Acetabular Component MC2P, and how would a clinician determine the correct fit for a patient?

  While the exact sizes or model variants are not detailed in the provided data, the device is categorized under product code JDL and is engineered for orthopedic use in acetabular replacement. Clinicians would typically select the appropriate size based on preoperative imaging (e.g., CT or X-ray) and surgical assessment of the patient’s pelvic anatomy to ensure proper fit and function during total hip arthroplasty.

• Does the Micro-Struc Acetabular Component MC2P require any special handling or storage conditions, such as sterility or environmental precautions?

  The available data does not specify any special sterility requirements or MRI safety considerations for the Micro-Struc Acetabular Component MC2P. However, as a reusable metal acetabular component intended for surgical use, it should be handled according to standard orthopedic surgical protocols, including proper cleaning, sterilization (if reused), and storage in a clean, dry environment to maintain its integrity before and after use.