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Pectofix Sternal Repair Wire

by Pectofix, Inc.

510(k) K003951

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003951 Date21 Mar 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JDQ
Device Class
Class II
Regulation
21 CFR Part 888.3010
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Pectofix Sternal Repair Wire is a metallic cerclage device classified as a bone fixation wire. Constructed from cobalt-chromium-molybdenum alloy, it is designed as a flat sheet or wire intended for internal fixation to stabilize sternal or orthopedic structures during surgical repair procedures.

This device is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K003951) with a product code of JDQ, classified under the Orthopedic advisory committee. The wire is intended for use in surgical settings where sternal or related orthopedic repairs are performed, adhering to standard sterile processing and handling protocols.

Other devices from Pectofix, Inc.

Questions

AI-generated answers, 1 Oct 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 Pectofix Sternal Repair Wire used for?

    The Pectofix Sternal Repair Wire is designed for internal fixation to stabilize sternal or orthopedic structures during surgical repair procedures. Its flat sheet or wire form provides mechanical support where sternal integrity is compromised, helping to maintain alignment and promote proper healing.

  • What material is the wire made from, and why is this important?

    The wire is constructed from a cobalt-chromium-molybdenum alloy, a durable and biocompatible material chosen for its strength, resistance to corrosion, and ability to withstand the mechanical stresses of surgical environments without degrading or causing adverse reactions.

  • Is the Pectofix Sternal Repair Wire sterile and single-use?

    Yes, the wire is supplied sterile and intended exclusively for single-use implantation. This ensures patient safety by preventing cross-contamination and maintains the integrity of the device’s sterile barrier, which is critical for surgical applications.

  • How is the wire supplied, and what should clinicians consider during handling?

    The wire is supplied sterile and ready for immediate use in surgical settings. Clinicians should adhere to standard sterile processing protocols, including proper packaging handling, to avoid compromising sterility before implantation. Its single-use nature also requires careful inventory management to ensure availability when needed.

  • What regulatory pathway does the Pectofix Sternal Repair Wire follow?

    The wire is regulated under the FDA’s 510(k) clearance process (K003951) and classified under the Orthopedic advisory committee (OR). It was determined to be substantially equivalent to a legally marketed predicate device, ensuring compliance with FDA standards for orthopedic fixation devices.