M2A-Magnum Tri-Spike Acetabular Component

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

510(k) Number

K062995 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Biomet Manufacturing Corp →

• What types of hip replacement surgeries is the M2A Magnum Tri-Spike Acetabular Component designed for, and what makes it unique in its construction?

  The M2A Magnum Tri-Spike Acetabular Component is designed specifically for total hip arthroplasty procedures, serving as a semi-constrained metal acetabular shell. Its unique construction includes a cobalt-chromium-molybdenum (Co-Cr-Mo) metal design for metal-on-metal articulation, a full hemisphere geometry, and three dome-shaped spikes on its outer surface to enhance rotational stability within the pelvis. The device also features a porous plasma spray coating to promote biological fixation, ensuring secure integration with the patient’s bone.

• Is this device intended for single-use or can it be reused? How is it packaged to ensure sterility?

  The M2A Magnum Tri-Spike Acetabular Component is supplied as a reusable surgical implant, meaning it is not designated for single-use. To maintain sterility, it must be packaged in sterile packaging before use in surgical procedures, as required for reusable medical devices.

• What sizes are available for the M2A Magnum Tri-Spike Acetabular Component, and how do I identify the correct variant for my patient?

  The device comes in outer diameters ranging from 44 mm to 66 mm, accommodating various patient anatomies. Each size and variant is associated with specific reference codes (e.g., 3020282716, 1047843) listed in the regulatory documentation. These codes help identify the exact model, ensuring compatibility with the patient’s surgical needs.

• How should the M2A Magnum Tri-Spike Acetabular Component be stored, and are there any special handling instructions?

  While the data does not specify detailed storage instructions, reusable medical devices like this acetabular component should generally be stored in a clean, dry environment, protected from contamination and physical damage. Since it is supplied sterile, it must be handled in accordance with sterile surgical protocols to prevent compromise before use.

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

  The M2A Magnum Tri-Spike Acetabular Component was cleared through the FDA’s 510(k) process (K062995) as a Class III device, with a determination of substantial equivalence to a predicate device. This means it has undergone FDA review to ensure safety and effectiveness for its intended use in total hip arthroplasty, adhering to regulatory standards outlined in 21 CFR 888.3330. Clinicians can rely on this clearance as evidence of its compliance with U.S. regulatory requirements.