# K242364: IdentiTi™ II Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 4, 2024 after 56 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, 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: 32 generations back to K841189 (1984). 1,404 ancestors in all.
4 later devices descend from it; 4 cite it directly.
2 of 1,409 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.
- K223611: Calibrate LTX Interbody System, Alphatec Spine, Inc. (2023) Summary page 5.
- 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, Alphatec Spine (2022) Summary page 5.
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System, Alphatec Spine, Inc. (2023) Summary page 5.
- 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, Alphatec Spine, Inc. (2022) Summary page 5.
- K202587: ATEC Lateral Interbody System, Alphatec Spine, Inc. (2020) Summary page 5.
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018) Summary page 5.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 5.
- K232275: Invictus® Spinal Fixation System, Alphatec Spine, Inc. (2023) Summary page 7.

## Most influential descendants
- K261020: Symmetrix™ L Spinal System (2026), 0 descendants of its own
- K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (2025), 0 descendants of its own
- K251080: IdentiTi II Cervical Interbody System (2025), 0 descendants of its own
- K251617: X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage System (2025), 0 descendants of its own

## Indications for use
The IdentiTi™ II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain) at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the IdentiTi II System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The IdentiTi II Interbody System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine. AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti-Migration Plate in addition to supplemental fixation.

Source page: https://510kreport.com/device/K242364
Methodology: https://510kreport.com/methodology