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Altus Spine Pedicle Screw System

by Altus Partners, LLC 4 variants

510(k) K211027

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 NumberK211027 Date16 Sep 2022ClearedStatusActive

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 Altus Spine Pedicle Screw System is a spinal fixation device classified as a pedicle screw and rod system (product code NKB). It is designed to provide immobilization and stabilization of spinal segments by anchoring screws into the vertebral bodies, facilitating fusion in the treatment of acute or chronic spinal instabilities or deformities in the thoracic, lumbar, or sacral regions of skeletally mature patients.

This system is supplied sterile and intended for single-use. It includes pedicle screws, rods, and locking components engineered for secure fixation. The device is regulated under FDA 510(k) clearance (K211027) as substantially equivalent to predicate devices, with no third-party involvement. Compliance with orthopedic surgical standards ensures compatibility with MRI-safe imaging protocols when used as intended.

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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 Altus Spine Pedicle Screw System used for?

    The Altus Spine Pedicle Screw System is designed to stabilize and immobilize spinal segments by anchoring screws into vertebral bodies. This helps facilitate spinal fusion in patients with acute or chronic spinal instabilities or deformities in the thoracic, lumbar, or sacral regions. It is intended for skeletally mature patients requiring surgical intervention for these conditions.

  • Is the Altus Spine Pedicle Screw System sterile and single-use?

    Yes, the system is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the integrity of the device for optimal performance during surgery.

  • What components are included in the Altus Spine Pedicle Screw System?

    The system includes pedicle screws, rods, and locking components. These components work together to provide secure fixation, enabling proper alignment and stabilization of the spine during fusion procedures.

  • Can the Altus Spine Pedicle Screw System be used with MRI-safe imaging?

    Yes, the device is engineered to comply with orthopedic surgical standards, allowing for compatibility with MRI-safe imaging protocols when used as intended. This ensures that postoperative imaging can be performed without interference from the hardware.

  • What regulatory clearance does the Altus Spine Pedicle Screw System hold?

    The system holds FDA 510(k) clearance (K211027) and is classified as substantially equivalent to predicate devices. This clearance was granted under the traditional review pathway by the Orthopedic (OR) Advisory Committee, confirming its compliance with safety and effectiveness standards for spinal fixation.