Parallel-Sided Extensively Coated Femoral Stems

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

510(k) Number

K073637 ↗

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 is the primary purpose of the Parallel-Sided Extensively Coated Femoral Stems in hip replacement surgery?

  These stems are designed as semi-constrained, uncemented hip prostheses to replace damaged or diseased natural femoral components. The parallel-sided cylindrical shape and extensively coated surface promote osseointegration—meaning they encourage bone growth into the implant—for long-term stability in the femur during hip arthroplasty procedures.

• Are these stems intended for single-use or can they be reused after sterilization?

  The stems are supplied as non-sterile and must be sterilized prior to use, but there is no explicit indication in the data that they are intended for reuse. Typically, uncemented hip stems like these are single-use implants, though sterilization protocols would determine reuse feasibility if required by a facility’s policies.

• What material is the Parallel-Sided Extensively Coated Femoral Stem made from, and how does that affect its performance?

  The stems are manufactured from wrought titanium alloy (Ti-6Al-4V), a material chosen for its strength, biocompatibility, and corrosion resistance. This alloy provides durability while allowing the porous coating to promote uncemented fixation by enabling bone ingrowth for secure integration into the femur.

• How do I determine the correct size or model for a patient’s procedure?

  The data lists multiple registration numbers (e.g., 3020282716, 1047843) associated with this device, which correspond to different sizes or models. To select the appropriate size, consult the manufacturer’s sizing guides or surgical planning tools, as these stems are custom-fit to the patient’s femoral anatomy during preoperative planning.

• What regulatory pathway was followed for FDA clearance of these stems, and what does that mean for clinicians?

  The stems were cleared via a Traditional 510(k) pathway (K073637) under FDA’s Orthopedic (OR) Advisory Committee, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined they meet the same performance criteria as a previously approved hip prosthesis, ensuring compliance with safety and effectiveness standards for uncemented femoral stems.