FDA.reportPublic FDA data

Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substitute

Primary DI
00850080243237
Brand
Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substitute
Company
BONE SOLUTIONS, INC.
Model
10cc
Catalog number
44-100-00-OPM
Device description
Mg OSTEOCRETE PROTEIN MATRIX™ is a magnesium-based synthetic bone graft substitute that is moldable/injectable, drillable/settable, adhesive/cohesive, radiopaque, osteoconductive, remodels into bone over time through creeping substitution. The Mg OSTEOCRETE PROTEIN MATRIX™ Packet contains powder (Magnesium based compound), mixing solution (modified saline) and allograft bone. The device is sterile, single use only.
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
MQVFiller, Bone Void, Calcium Compound
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2
OISCalcium Salt Bone Void Filler, Drillable, Non-Screw AugmentationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080243237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080243237008500802432378500802432370850080243237

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobialA bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.

Contacts#

Phone, Email table
PhoneEmail
8178098850customerservice@bonesolutions.net

Regulatory Flags#

DUNS number
003506272
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080243183Mg BVF EXTENDER™ bone graft substitute5cc44-050-00-EXT2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substitute10cc44-100-00-EXT2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substitute5cc44-050-00-OPM2026-10-29
00850080243176OSTEOROD Delivery SystemOSTEORODRM44-0702026-10-12
00850080243022Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-STR2026-06-18
00850080243039Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-STR2026-06-18
00850080243046Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-STR2026-06-18
00850080243053Mg OSTEOCRETE™ bone graft substitute5cc44-050-00-BSI2026-06-18
00850080243060Mg OSTEOCRETE™ bone graft substitute10cc44-100-00-BSI2026-06-18
00850080243077Mg OSTEOCRETE™ bone graft substitute15cc44-150-00-BSI2026-06-18
00850080243084Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2026-06-18
00850080243091Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2026-06-18
00850080243107Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2026-06-18
00850080243114Mg OSTEOINJECT® bone graft substitute5cc44-050-00-INJ2026-06-18
00850080243121Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2026-06-18
B4474410000INJ0Mg OSTEOINJECT® bone graft substitute10cc44-100-00-INJ2024-05-20
B4474405000REV0Mg OSTEOREVIVE™ bone graft substitute5cc44-050-00-REV2022-02-02
B4474410000REV0Mg OSTEOREVIVE™ bone graft substitute10cc44-100-00-REV2022-02-02
B4474415000REV0Mg OSTEOREVIVE™ bone graft substitute15cc44-150-00-REV2022-02-02
B4474405000INJ0Mg OSTEOINJECT® bone graft substitute5cc44-050-00-INJ2022-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243183Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.OIS2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243190Mg BVF EXTENDER™ bone graft substituteBONE SOLUTIONS, INC.OIS2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MBP2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.MQV2026-10-29
00850080243220Mg OSTEOCRETE PROTEIN MATRIX™ bone graft substituteBONE SOLUTIONS, INC.OIS2026-10-29
00199284455788BonVie+ELUTE , INC.MQV2025-08-13
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00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccSurgentec, LLCMQV2025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccSurgentec, LLCMQV2025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccSurgentec, LLCMQV2025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALSurgentec, LLCMQV2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALSurgentec, LLCMQV2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccSurgentec, LLCMQV2025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccSurgentec, LLCMQV2025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccSurgentec, LLCMQV2025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccSurgentec, LLCMQV2025-06-10
00850391007245Montage Settable Bone PuttyABYRX, INC.OIS2023-11-16
00850391007245Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.MQV2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.OIS2023-11-16