# K232097: IdentiTi ALIF Interbody Systems

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Sep 25, 2023 after 74 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 31 generations back to K841189 (1984). 1,168 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 1,176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 5.

## Most influential descendants
- K241375: IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer (2025), 3 descendants of its own
- K240126: ProAM ALIF System (2024), 2 descendants of its own
- K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (2025), 0 descendants of its own
- K252113: PRADO™ Lumbar Interbody Fusion System (2025), 0 descendants of its own
- K251080: IdentiTi II Cervical Interbody System (2025), 0 descendants of its own

## Recalls of this device
- Jan 26, 2024 · Class II · Z-1182-2024: Due to reports of intraoperative graft bolt implantation breakages.

## Indications for use
The IdentiTi ALIF Standalone Interbody System is indicated for spinal fusion procedures from L2 to S1 in skeletally mature patients for the treatment of symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis and/or spinal stenosis 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. These patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the IdentiTi ALIF Standalone Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis (>Grade 1) and spinal stenosis at one or two adjacent levels, the IdentiTi ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. 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 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. When used with three integrated screws, the IdentiTi ALIF Standalone Interbody System implants of <20° are a standalone system. When used with fewer than three integrated screws, and for interbody implants of >20°, the IdentiTi ALIF Standalone Interbody System implants must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi Porous Ti 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 Porous Ti Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The IdentiTi Porous Ti Interbody System is intended for use on patients who have had at least six months of non-operative 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 and supplemental fixation systems, regardless of the use of integrated fixation, that are cleared by FDA for use in the thoracic and lumbar spine.

Source page: https://510kreport.com/device/K232097
Methodology: https://510kreport.com/methodology