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Ultra Compression Screw System

by Pace Surgical

510(k) K251555

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251555 Date6 Nov 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultra Compression Screw System is a device for foot and ankle trauma and reconstruction. It includes solid and cannulated screws in various diameters ranging from 2 to 8mm and multiple length options, each available in partial and fully threaded variants. Headed screws, headless screws, and washers are available. All screws and washers are manufactured from Titanium Alloy (ASTM F136).

The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. It received FDA 510(k) clearance (K251555) as substantially equivalent to a predicate device. The system is used in surgical settings for foot and ankle procedures and is stored under standard conditions for reusable metal implants.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ultra Compression Screw System used for?

    The Ultra Compression Screw System is used for foot and ankle trauma and reconstruction procedures in surgical settings. It includes solid and cannulated screws, headed and headless screws, and washers designed for fixation in these anatomical areas.

  • How is the Ultra Compression Screw System supplied and is it sterile?

    The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user. It is not provided in a sterile condition and requires reprocessing before each surgical use.

  • What sizes and types of screws are included in the Ultra Compression Screw System?

    The system includes solid and cannulated screws in diameters ranging from 2 to 8mm with multiple length options. Each screw is available in partial and fully threaded variants, and the system also offers headed screws, headless screws, and washers.

  • What material are the screws and washers made from in the Ultra Compression Screw System?

    All screws and washers in the Ultra Compression Screw System are manufactured from Titanium Alloy (ASTM F136), which provides biocompatibility and mechanical strength suitable for implant use in foot and ankle surgery.

  • What regulatory pathway was used for the Ultra Compression Screw System?

    The device received FDA 510(k) clearance (K251555) as substantially equivalent to a predicate device, following a traditional review process. This clearance pathway confirms its substantial equivalence to a legally marketed device.