Class Class II
IdentiTi™ II Interbody System (K242364)
Description
IdentiTi™ II Interbody System by Alphatec Spine, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242364
Clearance Date2024-10-04
Clearance TypeTraditional
Product CodeMAX
Regulation Number888.3080
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242364
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IdentiTi™ II Interbody System (K242364) cites 5 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 |
| K231438 | Calibrate PSX Interbody System, Calibrate NanoTec PSX Inter... | Alphatec Spine, Inc. | 2023 |
| K223611 | Calibrate LTX Interbody System | Alphatec Spine, Inc. | 2023 |
| K222028 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec In... | Alphatec Spine | 2022 |
| K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent ... | Nu Vasive, Incorporated | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | 2025 |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF E... | Expanding Innovations, Inc. | 2025 |
Trace the full predicate network for K242364
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.