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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

FDA 510(k) clearance K261008 · decided 2026-04-24

Clearance details

K-number
K261008
Device name
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
Applicant
Stryker Spine
Decision
Substantially Equivalent
Date received
2026-03-26
Decision date
2026-04-24
Days to decision
29 days
Clearance type
Special
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Device 300419 Strip (K260364)Geistlich Pharma AG2026-06-02
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Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™ (K251522)Bone Solutions, Inc.2025-10-13
Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) (K252085)Wright Medical Technology, Inc. (Stryker Corporation)2025-09-30
Device 300423 Granules (K251556)Geistlich Pharma AG2025-07-17
OsteoFlo HydroFiber (K251720)SurGenTec, LLC2025-07-02
Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193)Medtronic Sofamor Danek, Inc.2025-06-12
OsteoFlo HydroFiber (K243949)SurGenTec, LLC2025-05-28
MagnetOs MIS (K243474)Kuros Biosciences B.V2025-05-23
Synthecure Synthetic Calcium Sulfate (K250141)Austin Medical Ventures, Inc.2025-05-16

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
RAY TFC AND RAY TFC UNITE (P950019/S014)Stryker Spine2004-03-25
RAY TFC UNITE (P950019/S016)Stryker Spine2003-10-10
RAY THREADED FUSION CAGE (TFC) (P950019/S015)Stryker Spine2003-09-04
RAY TFC UNITE PRODUCT LINE (P950019/S013)Stryker Spine2003-07-15
RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012)Stryker Spine2002-04-02
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01