Nonlinear Taper Lag Screw

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

510(k) Number

K994382 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Theken Surgical, Llc →

• What types of bone fixation procedures is the Nonlinear Taper Lag Screw designed for, and why does its tapered shank matter in those applications?

  The Nonlinear Taper Lag Screw is designed for orthopedic applications requiring secure internal fixation of bone fragments, particularly in cancellous bone. Its nonlinear tapered shank enhances stability by distributing mechanical load more effectively across the bone, reducing the risk of screw pull-out. This design is ideal for procedures where maintaining fixation strength is critical, such as fracture stabilization or arthroplasty.

• Is the Nonlinear Taper Lag Screw reusable in surgical settings, and if not, what does this mean for inventory management?

  No, the Nonlinear Taper Lag Screw is explicitly intended for single-use in surgical settings. This means each screw is sterilized for one-time use only, which helps prevent cross-contamination and ensures patient safety. For inventory management, this implies you’ll need to stock multiple sizes and quantities to account for surgical needs, as used screws cannot be reprocessed or reused.

• What does the FDA’s classification of this device as a Class II under the HWC product code mean for its regulatory oversight?

  The Class II designation under the HWC product code (screws for fixation) means this device is subject to special controls from the FDA, which include additional manufacturing and labeling requirements beyond general medical device regulations. While it does not require a premarket approval (PMA), Theken Surgical had to demonstrate substantial equivalence to a predicate device through a 510(k) clearance process—in this case, reviewed under the Traditional pathway by the Orthopedic (OR) Advisory Committee. This ensures the device meets performance and safety standards for its intended use.

• How do the available sizes of the Nonlinear Taper Lag Screw accommodate different clinical scenarios, and what should clinicians consider when selecting a size?

  The Nonlinear Taper Lag Screw is supplied in various sizes, though the exact dimensions are not specified in the data. Clinicians should select a size based on the bone density, fracture pattern, and anatomical location to ensure proper fixation. The tapered design allows for better load distribution, but oversizing or undersizing could compromise stability or risk damage to surrounding bone. Always refer to the manufacturer’s sizing guidelines or surgical technique notes for optimal selection.