Compression Hip Screw Side-Plate

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

510(k) Number

K823548 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Howmedica Corp. →

• Is this device intended for single-use or can it be reused in multiple surgeries?

  This device is explicitly described as a reusable medical instrument, meaning it is designed for repeated use in multiple surgical procedures after proper cleaning, sterilization, and maintenance. Since it is classified as an orthopedic fixation appliance, its reuse follows standard surgical protocols for reusable orthopedic tools, which include thorough decontamination and sterilization between cases.

• What types of fractures is this device primarily used to stabilize in the proximal femur?

  The Compression Hip Screw Side-Plate is designed to stabilize and support the proximal femur, particularly in cases requiring fracture fixation. While the exact fracture types are not specified, its combination of a compression screw and side-plate is typically used for intertrochanteric or subtrochanteric fractures where enhanced stability during bone healing is critical. The device’s mechanism ensures compression at the fracture site to promote alignment and healing.

• How is this device supplied, and what considerations should be made for storage?

  The Compression Hip Screw Side-Plate is supplied as part of a reusable orthopedic fixation system, meaning it is not pre-packaged for single-use but rather intended for surgical use after proper sterilization. Storage must adhere to standard orthopedic surgical protocols, including protection from moisture, contamination, and physical damage. Since no specific sterility or MRI safety details are provided, it is assumed to follow general orthopedic instrument storage guidelines—clean, dry, and in a controlled environment to maintain functionality and sterility readiness.

• What was the regulatory pathway and decision for FDA clearance of this device?

  This device received FDA 510(k) clearance under the product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component) in 1982. The decision was classified as Substantially Equivalent (SESE), meaning the FDA determined it had the same intended use and technological characteristics as a legally marketed predicate device. The review was conducted by the Orthopedic (OR) Advisory Committee under a traditional 510(k) pathway, with Howmedica Corp. as the applicant. No additional details on the predicate device are provided.