Taperloc Complete, Size 5 and 6

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

510(k) Number

K103755 ↗

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 procedures is the Taperloc Complete designed for, and why is it considered semi-constrained?

  The Taperloc Complete is designed specifically for hip joint replacement procedures, particularly as an acetabular component in total hip arthroplasty. It is classified as semi-constrained to provide enhanced stability within the pelvic bone while still allowing some degree of natural joint motion. This design balances structural support with flexibility to accommodate patient movement post-surgery.

• Is the Taperloc Complete reusable or intended for single-use, and how is it supplied?

  The Taperloc Complete is intended for single-use only and is supplied sterile to ensure patient safety and infection control. This aligns with standard practices for orthopedic implants to prevent cross-contamination and maintain sterility during surgical procedures.

• What sizes are available for the Taperloc Complete, and how does this affect its use?

  The Taperloc Complete is available in two sizes: 5 and 6. These sizes correspond to different patient anatomies and pelvic structures, allowing surgeons to select the appropriate component for optimal fit and stability during hip replacement surgery. Proper sizing is critical to ensure proper alignment and function of the implant.

• How is the Taperloc Complete regulated, and what does the FDA clearance indicate about its safety and effectiveness?

  The Taperloc Complete has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device that was not subject to premarket approval. This clearance indicates that the device meets FDA standards for safety and performance, though it does not imply FDA approval for specific clinical outcomes or indications beyond its intended use as described.

• What special considerations should be taken into account when storing the Taperloc Complete?

  While the data does not specify storage conditions explicitly, as a sterile, single-use orthopedic implant, the Taperloc Complete should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Adherence to manufacturer guidelines for sterile packaging and handling is essential to maintain its integrity before surgical use.