510(k) Report

Devices descending from K152022

149 later devices reach SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+4K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+4K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+4K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+4K222561AlignAcuity Surgical Devices, LLC202214—
+4K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+4K220610SOLO-LAurora Spine, Inc.20220—
+4K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+4K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+6K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+6K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+6K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+7K261279DeltaNEC Interbody SystemNexus Spine20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—