# K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine
- Decided: Sep 3, 2025 after 104 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: 33 generations back to K841189 (1984). 1,498 ancestors in all.
No later device cites it as a predicate yet.
2 of 1,499 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Alphatec Spine (2025) Summary page 6.
- K160597: INDEPENDENCE MIS Spacers, Globus Medical, Inc. (2016) Summary page 6.
- K242364: IdentiTi™ II Interbody System, Alphatec Spine, Inc. (2024) Summary page 6.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 6.
- K203742: IdentiTi ALIF Standalone Interbody System, Alphatec Spine, Inc. (2021) Summary page 6.
- K182746: ATEC ALIF and LLIF Spacer System, Alphatec Spine, Inc. (2018) Summary page 6.
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 6.
- K083475: Lucent Magnum, Spinal Elements, Inc. (2009) Summary page 6.
- K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System, Alphatec Spine, Inc. (2011) Summary page 6.

## Indications for use
IdentiTi II ALIF Standalone Interbody System The IdentiTi II 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. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the IdentiTi II 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 II ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The IdentiTi II ALIF Standalone 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 three (3) screws, interbody implants of <20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation. When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation. When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation. Transend ALIF Standalone Interbody System The Transcend 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. When used with screws or blades, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Transcend 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 Transcend ALIF Standalone Interbody System must be used with supplemental spinal fixation systems cleared by the FDA for use in the lumbar spine. The Transcend ALIF Standalone 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 three (3) screws, interbody implants of <20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation. When used with three (3) blades, a combination of three (3) screws and blades, or less than three (3) screws and/or blades, interbody implants must always be used with supplemental fixation. When used with or without screws and/or blades, interbody implants of >20° must always be used with supplemental fixation.

Source page: https://510kreport.com/device/K251575
Methodology: https://510kreport.com/methodology