Taperloc Complete Microplasty Stem

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

510(k) Number

K110400 ↗

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 replacements is the Taperloc Complete Microplasty Stem designed for, and how does it differ from other acetabular components?

  The Taperloc Complete Microplasty Stem is specifically designed for cementless hip arthroplasty, focusing on biological fixation with the femoral bone. It is a semi-constrained, uncemented acetabular component with a porous-coated femoral stem, which promotes integration and stability without the need for bone cement. This distinguishes it from cemented stems or fully constrained designs, as it relies on osseointegration for long-term stability.

• Are there different sizes or offsets available for this device, and how might that affect my surgical planning?

  Yes, the Taperloc Complete Microplasty Stem is supplied in multiple sizes and offsets, including standard and shortened Microplasty stem lengths. This variability allows surgeons to select the appropriate fit for the patient’s anatomy, ensuring proper alignment and stability during hip replacement. The shortened lengths may be particularly useful for patients with limited femoral bone stock or specific anatomical constraints.

• Is the Taperloc Complete Microplasty Stem intended for single-use or can it be reused in a clinical setting?

  The provided data does not explicitly state whether the Taperloc Complete Microplasty Stem is sterile or intended for single-use. However, as it is a porous-coated, uncemented implant, it is typically designed for single-patient use to maintain sterility and reduce infection risks. Reuse would require strict reprocessing protocols, which are not mentioned in the documentation, so it is safest to assume it is intended for single-use.

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

  The Taperloc Complete Microplasty Stem was cleared through the FDA 510(k) pathway, specifically under Traditional Review by the Orthopedic (OR) Advisory Committee. It was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets FDA standards for safety and effectiveness as a Class III medical device for orthopedic use. This clearance allows it to be legally marketed and used in U.S. clinical settings for hip arthroplasty procedures.