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Macropore Hydrosorb Spine System

by Macropore Biosurgery, Inc.

510(k) K041105

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 NumberK041105 Date28 Jul 2004ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
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 Macropore Hydrosorb Spine System is a bioresorbable polymer implant designed for spinal fusion and spine graft fixation. It is intended for use in treating diseases, deformities, or trauma of the musculoskeletal system, particularly in hard tissue (bone) applications.

The device is supplied as a sterile, single-use implant and has received FDA 510(k) clearance under K041105. It is manufactured by Macropore Biosurgery, Inc. and is indicated for use in spinal procedures as a substantially equivalent device to previously cleared products.

Other devices from Macropore Biosurgery, Inc.

See all devices from Macropore Biosurgery, 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 Macropore Hydrosorb Spine System used for?

    It is designed for spinal fusion and spine graft fixation in treating diseases, deformities, or trauma of the musculoskeletal system, specifically in hard tissue (bone) applications, as a bioresorbable polymer implant.

  • How is the Macropore Hydrosorb Spine System supplied and is it reusable?

    The device is supplied as a sterile, single-use implant, meaning it is intended for one-time use only and should not be reprocessed or reused after implantation.

  • What regulatory clearance does the Macropore Hydrosorb Spine System have?

    It has received FDA 510(k) clearance under submission number K041105, determined to be substantially equivalent to previously cleared devices for spinal procedures.