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AttraX Scaffold

by Nu Vasive, Incorporated

510(k) K172497

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 NumberK172497 Date24 Nov 2017ClearedStatusActive

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  • Withdrawn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)

Full name
NuVasive AttraX Scaffold
510(k) Number
FDA Product Code
MQV
Device Class
Class II
Regulation
21 CFR Part 888.3045
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 AttraX Scaffold is a calcium-based bone void filler classified under product code MQV, designed to fill and support bone defects. It is intended for use as a structural substitute in orthopedic applications, providing a scaffold for bone regeneration and integration.

This device is supplied as a single-use, sterile product and is intended for use in surgical settings where bone voids require filling. The scaffold’s microstructure and microporosity are optimized for bone formation, promoting differentiation of mesenchymal stem cells into osteoblasts. Authorized under FDA 510(k) clearance (K172497), it adheres to Class II – Special Controls for bone void fillers.

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Questions

AI-generated answers, 19 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 types of bone defects is the NuVasive AttraX Scaffold specifically designed to address in surgical settings?

    The AttraX Scaffold is engineered as a calcium-based bone void filler to fill and structurally support bone defects in orthopedic applications. Its microstructure and microporosity are optimized to promote bone regeneration by encouraging mesenchymal stem cells to differentiate into osteoblasts, making it suitable for surgical scenarios where bone voids require filling and integration.

  • Is the NuVasive AttraX Scaffold intended for single-use or can it be reused after surgery?

    The AttraX Scaffold is explicitly supplied as a single-use, sterile product. This design ensures patient safety and sterility, as it is intended for use in surgical settings where maintaining sterility is critical.

  • How is the NuVasive AttraX Scaffold authorized for use in the United States?

    The AttraX Scaffold received FDA clearance through a 510(k) submission (K172497) under the Traditional review pathway, classified as substantially equivalent to a predicate device. It adheres to Class II – Special Controls for bone void fillers, ensuring compliance with regulatory standards for orthopedic bone void fillers.

  • What distinguishes the AttraX Scaffold’s design from other bone void fillers in terms of bone regeneration?

    The AttraX Scaffold features a calcium-based composition with a microstructure and microporosity specifically engineered to support bone regeneration. Its design promotes the differentiation of mesenchymal stem cells into osteoblasts, facilitating better integration and growth of new bone tissue within the defect site.