Gladiator Plasma Classic Hip Stem

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K110399 ↗

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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• What types of hip procedures is the Gladiator Plasma Classic Hip Stem designed for, and how does its design support stability during use?

  The Gladiator Plasma Classic Hip Stem is designed specifically for total hip arthroplasty (replacement surgery) as a semi-constrained metal prosthesis. Its uncemented acetabular component is intended for orthopedic procedures where secure fixation is critical. The stem’s monolithic, straight design with a rectangular distal cross-section and proximal trapezoidal section enhances fixation stability in three planes, while its vertically tapered profile in frontal and lateral planes improves biomechanical stability during weight-bearing and movement.

• Is the Gladiator Plasma Classic Hip Stem intended for single-use or reusable applications, and what packaging requirements apply?

  The Gladiator Plasma Classic Hip Stem is supplied as a reusable surgical implant, meaning it is intended for multiple uses in different patients after proper cleaning, sterilization, and maintenance. Since it is a reusable device, it must be packaged sterile to ensure safety and compliance with surgical standards before each use. Sterility is critical to prevent infection and contamination during orthopedic procedures.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians or hospitals considering its use?

  The Gladiator Plasma Classic Hip Stem received FDA 510(k) clearance (K110399) under the Traditional 510(k) Review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the FDA determined the device’s design and performance meet the same regulatory standards as an existing, cleared hip prosthesis. Clinicians or hospitals can rely on this clearance as evidence of the device’s safety and effectiveness for total hip arthroplasty, though they should always follow local protocols and manufacturer guidelines for proper use.

• Does this device come in multiple sizes or models, and how might a surgeon determine the appropriate fit for a patient?

  The Gladiator Plasma Classic Hip Stem is available in multiple sizes, as indicated by the extensive list of FEI numbers (Foreign Entity Identification numbers) in the regulatory data. These numbers correspond to different inventory or stock-keeping units, which likely represent variations in stem length, diameter, or other dimensional specifications. Surgeons typically select the appropriate size based on preoperative imaging (X-rays or CT scans), patient anatomy, bone density, and clinical assessment to ensure proper fit, stability, and functional outcomes during total hip replacement.