510(k) K253524

Device: Adaptos®Fuse Bone Graft
Applicant: Biomendex OY
510(k) number: K253524
Product code: MQV
Decision: Substantially Equivalent (SESE)
Decision date: 2026-02-17
Date received: 2025-11-13
Regulation: 888.3045
Classification name: Filler, Bone Void, Calcium Compound
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Pasi Kankaanpää
Address: Korkeakoulunkatu 1 Tampere FI 33720 33720

FDA Registration Numbers

1423662
1450662
3006788678
3043620406
3005180920
3013820501
1645368
1416980
3006404071
3013176080
2650143
3002807315
3010197239
3008147766
3011964577
2027062
1043534
1720734
3004464325
9617083
3011483489
3011662387
1824199
2032098
1644312
3010770940
2249915
3014560508
1833920
3025603301
3010258202
3012270469
3007738819
2031093
3008132398
3034676720
3004142400
1225991
3007193505
1219655
9610612
1526439
3010202439
2246552
1319660
2027754
1721676
3015219237
3005581234
3003771570
3005819474
9614442
3010162973
3016592693
3027339877
3005972619
2024024
3002807314
3008773560
9615788
3012495575
9611390
3009756327
3010376334
1417485
3006121828
2249852
3005031160
3010132111
3010331645
3011302692
1216032
3010275504
3016438694
3008514120
3013282271
3008110533
3009672666
3010097171

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MQV

510(k)	Device	Applicant	Decision date
K261008	Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute	Stryker Spine	2026-04-24
K253147	FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute	Prosidyan, Inc.	2025-10-22
K251522	Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE	Bone Solutions, Inc.	2025-10-13
K252085	Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)	Wright Medical Technology, Inc. (Stryker Corporation)	2025-09-30
K251556	Device 300423 Granules	Geistlich Pharma AG	2025-07-17
K251720	OsteoFlo HydroFiber	SurGenTec, LLC	2025-07-02
K251193	Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft	Medtronic Sofamor Danek, Inc.	2025-06-12
K243949	OsteoFlo HydroFiber	SurGenTec, LLC	2025-05-28
K243474	MagnetOs MIS	Kuros Biosciences B.V	2025-05-23
K250141	Synthecure Synthetic Calcium Sulfate	Austin Medical Ventures, Inc.	2025-05-16
K250521	NanoBone® SBX Putty ; NanoBone® QD	Biocomposites, Ltd.	2025-04-07
K250556	Porous Biologic Scaffold	Ventris Medical	2025-03-21
K250346	BonVie+	Elute, Inc.	2025-02-26
K241555	Moldable Bone Void Filler and Moldable Bone Void Filler + CCC	Rti Surgical, Inc.	2025-02-21
K243706	Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules	Medtronic Sofamor Danek, Inc.	2025-01-17