# K222455: Calibrate LTX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Nov 18, 2022 after 95 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: 28 generations back to K841189 (1984). 579 ancestors in all.
8 later devices descend from it; 1 cites it directly.
1 of 588 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211805: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System, Alphatec Spine, Inc. (2021) Summary page 4.
- K211873: PSX Interbody System, Alphatec Spine, Inc. (2021) Summary page 4.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 4.
- K191005: ProLift® Expandable System, Life Spine, Inc. (2019) Summary page 4.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K223611: Calibrate LTX Interbody System (2023), 7 descendants of its own
- 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

## Indications for use
The Calibrate LTX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degenerative disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). Lumbar: L1-L2 to L5-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 Calibrate LTX 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 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.

Source page: https://510kreport.com/device/K222455
Methodology: https://510kreport.com/methodology