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Device Explorer · FDA GUDID · GMDN 47257

Human-derived demineralized bone matrix implant

An implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery,

US‑registered devices860in commercial distribution
Companies25labelers on GUDID
Single‑use100%of device records
Sterile95%labelled sterile
Prescription97%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Xtant Medical Holdings, Inc.20624%
Hans Biomed Corp.12515%
Rti Surgical, Inc.9511%
Medtronic Sofamor Danek, Inc.799%
Isotis Orthobiologics, Inc.718%
Musculoskeletal Transplant Foundation, Inc.364%
Allosource243%
Lifenet Health223%

Top labelers

CompanyDevicesShare
Xtant Medical Holdings, Inc.20624%
Hans Biomed Corp.12515%
Rti Surgical, Inc.9511%
Medtronic Sofamor Danek, Inc.799%
Isotis Orthobiologics, Inc.718%
Musculoskeletal Transplant Foundation, Inc.364%
Allosource243%
Lifenet Health223%
Stryker Corporation212%
Wright Medical Technology, Inc.202%
Seaspine Orthopedics Corporation202%
Nuvasive, Inc.192%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIO DBMNAAntmedRTI Allograft PastePliaFX FloOptium®VESUVIUS™IGNITE 2.0IGNITE™ 2.0MINI IGNITE 2.0BEAST PLUSBEAST Injectable PuttyXEMPLIFIPuros®Reficio DBM PlusReficio DBM Paste

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MQVFiller, Bone Void, Calcium Compound480
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)449
MQVFILLER, BONE VOID, CALCIUM COMPOUND414
MBPFiller, bone void, osteoinduction (w/o human growth factor)260
NUNBone Grafting Material, Human Source71
GXPMethyl Methacrylate For Cranioplasty58

GMDN & GCC registration

  • GMDN code 47257 · implantable
  • Single‑use 100% · sterile 95% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 61Width (Centimeter) · 19Length (Centimeter) · 18Length (Millimeter) · 9Width (Millimeter) · 7Height (Centimeter) · 3

Use these as the dimensions to specify in a tender line.

How many human-derived demineralized bone matrix implant products are registered in the US?

860 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Human-derived demineralized bone matrix implant", from 25 companies. The largest labeler is Xtant Medical Holdings, Inc. with 24% of records.

Which FDA product codes apply?

MQV (Filler, Bone Void, Calcium Compound), MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)), MQV (FILLER, BONE VOID, CALCIUM COMPOUND), MBP (Filler, bone void, osteoinduction (w/o human growth factor))

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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