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TiLock Pedicle Screw System

by Genesys Spine

510(k) K100757

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK100757 Date1 Jul 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2677-2014 FDA Class II initiated 2 Apr 2014

    The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 TiLock Pedicle Screw System is a polyaxial cannulated pedicle screw system designed for spinal fixation. It is intended for use in minimally invasive surgery (MIS) procedures, utilizing K-wires and fluoroscopy to enable smaller incisions.

The system is supplied as a reusable instrument set and is indicated for orthopedic spinal applications. It is available in various lengths and diameters, and includes features such as a 120mm one-piece breakaway tower and offset connectors for medial-lateral variability. The device received FDA 510(k) clearance (K100757) and is classified under product code NKB.

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Questions

AI-generated answers, 25 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 TiLock Pedicle Screw System used for?

    The TiLock Pedicle Screw System is designed for spinal fixation in orthopedic applications, specifically intended for use in minimally invasive surgery procedures that utilize K-wires and fluoroscopy to enable smaller incisions.

  • Is the TiLock Pedicle Screw System reusable or single-use?

    The TiLock Pedicle Screw System is supplied as a reusable instrument set, meaning the components are designed for multiple uses after appropriate cleaning and sterilization between procedures.

  • What sizes and configurations are available for the TiLock Pedicle Screw System?

    The system is available in various lengths and diameters and includes features such as a such as a 120mm one-piece breakaway tower and offset connectors to provide medial-lateral variability during spinal fixation.

  • How is the TiLock Pedicle Screw System supplied for use in surgery?

    The system is supplied as a reusable instrument set and is intended to be used with K-wires and fluoroscopy to support minimally invasive surgical techniques, allowing for smaller incisions during pedicle screw placement.

  • What regulatory pathway was used for the TiLock Pedicle Screw System?

    The TiLock Pedicle Screw System received FDA 510(k) clearance under submission number K100757 and is classified under product code NKB, indicating it was found substantially equivalent to a legally marketed predicate device.