M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads

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

510(k) Number

K061423 ↗

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 surgical procedures are the M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads designed for?

  These components are specifically designed for total hip arthroplasty (replacement surgery) where a semi-constrained metal acetabular component is required. The modular design allows for customization to fit varying anatomical needs in the pelvis, ensuring secure, uncemented fixation.

• Are the M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads reusable or intended for single-use?

  The M2A Magnum components are explicitly supplied sterile and intended for single-use only in orthopedic surgical settings. Reuse is not recommended or supported by the manufacturer.

• How do I store the M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads before use?

  While the data does not specify exact storage conditions, the components are supplied sterile, so they should be stored in a clean, dry environment as per standard orthopedic implant protocols. Avoid exposure to moisture, extreme temperatures, or contamination to maintain sterility.

• What regulatory pathway was followed for FDA clearance of these devices?

  The M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads received FDA 510(k) clearance (K061423) under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. They are classified as Class III medical devices and comply with FDA regulation 888.3330 for orthopedic implants.

• Are there multiple sizes or models available for the M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads?

  Yes, the system includes interchangeable taper inserts (12/14 taper) and one-piece modular heads, allowing for customization to accommodate different anatomical requirements in total hip arthroplasty. The exact sizing options are detailed in the manufacturer’s technical documentation, but the modularity ensures flexibility in surgical planning.