Skip to content

Signify Bioactive

by Globus Medical, Inc.

510(k) K130977

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 NumberK130977 Date24 Dec 2013ClearedStatusActive

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  • Withdrawn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
MQV
Device class
Class II
Regulation
21 CFR Part 888.3045
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

Signify Bioactive is a resorbable, osteoconductive, and osteostimulative bone void filler. The device is designed to provide a matrix for new bone growth while containing chemistry that recruits and stimulates osteoblasts to promote bone formation.

This device is supplied for use as a bone void filler and is replaced by bone during the healing process. It is authorized under FDA 510(k) clearance K130977.

Other devices from Globus Medical, Inc.

See all devices from Globus Medical, Inc. →

Questions

AI-generated answers, 24 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 primary function of Signify Bioactive?

    Signify Bioactive is a bone void filler designed to serve as a scaffold for new bone growth. It is both osteoconductive and osteostimulative, meaning it provides a matrix for bone formation while also containing chemistry that recruits and stimulates osteoblasts to promote the healing process.

  • Is Signify Bioactive a permanent implant?

    No, Signify Bioactive is a resorbable device. It is designed to be replaced by the patient's own natural bone tissue as the healing process progresses.

  • What is the regulatory status of this bone void filler?

    Signify Bioactive is authorized for use under FDA 510(k) clearance, specifically identified by K-number K130977. This indicates the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.