Devices descending from K190655
74 later devices reach SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | SeaSpine Orthopedics Corporation | 2021 | 39 | — |
| +1 | K201646 | Shoreline ACS (Anterior Cervical System) | SeaSpine Orthopedics Corporation | 2020 | 20 | — |
| +1 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | 25 | — |
| +2 | K250076 | Endeavor™ Stand-Alone Cervical IBF System | Innovasis | 2025 | 0 | — |
| +2 | K243188 | Cylox® ST | Signus Medizintechnik GmbH | 2025 | 0 | — |
| +2 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody… | Orthofix Medical, Inc. | 2024 | 2 | — |
| +2 | K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System… | SeaSpine Orthopedics Corporation | 2024 | 3 | — |
| +2 | K240566 | Reef L Interbody System; WaveForm L Interbody System | SeaSpine Orthopedics Corporation | 2024 | 5 | — |
| +2 | K232348 | RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System | MiRus, LLC | 2023 | 1 | — |
| +2 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | 0 | — |
| +2 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior… | Gbs Commonwealth Co., Ltd. | 2023 | 3 | — |
| +2 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | Alphatec Spine | 2022 | 28 | — |
| +2 | K211417 | F3D-C2 Cervical Stand-Alone System | Corelink, LLC | 2022 | 3 | — |
| +2 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | 18 | — |
| +2 | K201193 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu… | SeaSpine Orthopedics Corporation | 2020 | 18 | — |
| +3 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer… | SeaSpine Orthopedics Corporation | 2026 | 0 | — |
| +3 | K260036 | NeckTune™ 3D SA Cervical Cage | Medyssey Co, Ltd. | 2026 | 0 | — |
| +3 | K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026 | 0 | — |
| +3 | K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | 2026 | 0 | — |
| +3 | K251735 | Stabilis SA Cervical Stand-Alone System (Various PNs) | Acuity Surgical Devices, LLC | 2025 | 1 | — |
| +3 | K250987 | aprevo® posterior/transforaminal lumbar interbody fusion device | Carlsmed, Inc. | 2025 | 1 | — |
| +3 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System | Expanding Innovations, Inc. | 2025 | 0 | — |
| +3 | K241375 | IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi… | Alphatec Spine | 2025 | 3 | — |
| +3 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | 5 | — |
| +3 | K242364 | IdentiTi™ II Interbody System | Alphatec Spine, Inc. | 2024 | 4 | — |
| +3 | K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | 2024 | 1 | — |
| +3 | K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024 | 4 | — |
| +3 | K240368 | E3D™-A Interbody System | Evolution Spine | 2024 | 7 | — |
| +3 | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | SeaSpine Orthopedics Corporation | 2023 | 8 | — |
| +3 | K232504 | Calibrate CCX Interbody System | Alphatec Spine, Inc. | 2023 | 1 | 1 |
| +3 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior… | Gbs Commonwealth Co., Ltd. | 2023 | 2 | — |
| +3 | K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023 | 7 | 1 |
| +3 | K230608 | SPICCA Stand-Alone Cervical Fusion Cages | Southern Medical (Pty), Ltd. | 2023 | 0 | — |
| +3 | K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +3 | K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 | 7 | — |
| +3 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | 5 | — |
| +3 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | 5 | — |
| +3 | K222903 | Tailored-H Cervical Stand Alone System | Bespoke Technologies, LLC | 2022 | 0 | — |
| +3 | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | SeaSpine Orthopedics Corporation | 2022 | 10 | — |
| +3 | K210583 | SeaSpine WaveForm™ A Interbody System | SeaSpine Orthopedics Corporation | 2021 | 14 | — |
| +4 | K261020 | Symmetrix™ L Spinal System | Medtronic Sofamor Danek USA, Inc. | 2026 | 0 | — |
| +4 | K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026 | 0 | — |
| +4 | K260385 | aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and… | Carlsmed, Inc. | 2026 | 0 | — |
| +4 | K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026 | 0 | — |
| +4 | K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026 | 0 | — |
| +4 | K253377 | Expandable Titanium PLIF/TLIF System | Spectrum Spine, Inc. | 2025 | 0 | — |
| +4 | K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025 | 0 | — |
| +4 | K252113 | PRADO™ Lumbar Interbody Fusion System | Bethesda Medical Devices | 2025 | 0 | — |
| +4 | K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 | 0 | — |
| +4 | K242928 | Tesera-k SC System | Kyocera Medical Technologies, Inc. | 2025 | 0 | — |
| +4 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | 2 | — |
| +4 | K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar… | Carlsmed, Inc. | 2025 | 3 | — |
| +4 | K243461 | Calibrate Interbody Systems | Alphatec Spine, Inc. | 2025 | 0 | — |
| +4 | K242517 | ProAM ACDF System | Pro Surgical, Inc. | 2024 | 0 | — |
| +4 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | 3 | — |
| +4 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | 6 | — |
| +4 | K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024 | 2 | — |
| +4 | K233694 | Meridian Interbody System; WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2024 | 8 | — |
| +4 | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT… | Gbs Commonwealth Co., Ltd. | 2023 | 1 | — |
| +4 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | 3 | — |
| +4 | K222732 | WaveForm A Interbody System | SeaSpine Orthopedics Corporation | 2022 | 9 | — |
| +4 | K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | 2022 | 2 | — |
| +5 | K262094 | E3D™-C Interbody System | Evolution Spine | 2026 | 0 | — |
| +5 | K260038 | E3D™-C Interbody System | Evolution Spine | 2026 | 1 | — |
| +5 | K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | 2026 | 1 | — |
| +5 | K250827 | aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion… | Carlsmed, Inc. | 2025 | 2 | — |
| +5 | K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025 | 0 | — |
| +5 | K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025 | 0 | — |
| +5 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | 2 | — |
| +5 | K240749 | PILLAR SA Ti Spacer System (82-XXX) | Orthofix, Inc. | 2024 | 0 | 2 |
| +5 | K234087 | restor3d TIDAL Lumbar Interbody Fusion System | Restor3D | 2024 | 0 | — |
| +5 | K223326 | Axiom PSR System | Restor3D | 2023 | 0 | 1 |
| +6 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | 1 | — |
| +7 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | 0 | — |