# K203742: IdentiTi ALIF Standalone Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Apr 9, 2021 after 108 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 28 generations back to K841189 (1984). 781 ancestors in all.
59 later devices descend from it; 4 cite it directly.
2 of 841 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182139: AXTi Titanium Stand-Alone ALIF System, Innovasis, Inc. (2019) Summary page 4.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019)
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015)
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 4.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018)
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018)
- K011556: Macs Hma Anterior Spinal Stabilization System, Aesculap, Inc. (2001) Summary page 4.
- K102334: TRANS1 Axialif Plus, Trans1 Incorporated (2011) Summary page 5.
- K073109: Stalif TT Intervertebral Body Fusion System, Surgicraft, Ltd. (2008) Summary page 5.
- K181818: Scarlet AL-T, Spineart (2018)
- K162236: Ax Stand-Alone ALIF System, Innovasis, Inc. (2017) Summary page 5.
- K202812: IdentiTi Cervical Standalone Interbody System, Alphatec Spine, Inc. (2020) Summary page 5.
- K203056: Invictus™ Spinal Fixation System, Alphatec Spine, Inc. (2020) Summary page 5.
- K161363: Arsenal Spinal Fixation System, Alphatec Spine, Inc. (2016) Summary page 5.

## Most influential descendants
- K220782: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System (2022), 36 descendants of its own
- K222028: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System (2022), 28 descendants of its own
- K214006: Invictus® Spinal Fixation System (2022), 16 descendants of its own
- K221926: Invictus® Bone Cement, Invictus Spinal Fixation System (2022), 14 descendants of its own
- K222973: IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem (2022), 13 descendants of its own

## Indications for use
The IdentiTiTm ALIF Standalone Interbody System is indicated for spinal fusion procedures in skeletally mature patients. The IdentiTi ALIF Standalone Interbody System implants of <200 are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >200 must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine in addition to the integrated screws. The IdentiTi ALIF Standalone Interbody System is intended for use at one or two contiguous levels in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The IdentiTi ALIF Standalone Interbody System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Source page: https://510kreport.com/device/K203742
Methodology: https://510kreport.com/methodology