44mm E1 Acetabular Liner with 44mm Biolox Delta Option Ceramic Head or 44mm M a Magnum

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

510(k) Number

K093549 ↗

FDA Product Code

LZO

Device Class

Class II

Regulation

21 CFR Part 888.3353

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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• What is the 44MM E1 acetabular liner used for?

  The 44MM E1 acetabular liner is used in total hip replacement procedures to articulate with either a 44mm Biolox Delta ceramic head or a 44mm M A Magnum modular head, providing a metal/ceramic/polymer bearing surface in semi-constrained hip prostheses.

• How is the 44MM E1 acetabular liner supplied and is it sterile?

  The device is supplied sterile for single-use implantation in total hip arthroplasty, packaged to maintain sterility until point of use, and is not intended for reprocessing or reuse after implantation.

• What head options are compatible with the 44MM E1 acetabular liner?

  The liner is designed to be used exclusively with either a 44mm Biolox Delta option ceramic head or a 44mm M A Magnum modular head, as specified in its labeling and clearance documentation.

• Can the 44MM E1 acetabular liner be used with cemented or non-cemented femoral components?

  Yes, the device is indicated for use with both cemented and non-cemented femoral and acetabular components in total hip replacement, allowing flexibility in fixation technique based on surgeon preference and patient factors.

• What regulatory pathway was used for the 44MM E1 acetabular liner?

  The device received FDA 510(k) clearance under submission K093549, demonstrating substantial equivalence to a legally marketed predicate device, with product code LZO assigned for classification.