# K223611: Calibrate LTX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Mar 29, 2023 after 117 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: 31 generations back to K841189 (1984). 1,191 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 1,199 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 4.
- K222455: Calibrate LTX Interbody System, Alphatec Spine, Inc. (2022) Summary page 4.

## Most influential descendants
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own
- K242147: Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (2024), 1 descendant of its own
- 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

## Indications for use
The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients for the treatment of a symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, spinal stenosis, and/or thoracic disc herniation (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 Calibrate LTX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate LTX 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 that are cleared by FDA for use in the thoracic and lumbar spine. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-X System as integrated fixation in addition to supplemental fixation.

Source page: https://510kreport.com/device/K223611
Methodology: https://510kreport.com/methodology