# K232504: Calibrate CCX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 13, 2023 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 32 generations back to K841189 (1984). 1,188 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 1,190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System, Alphatec Spine, Inc. (2023) Summary page 4.
- K171848: FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers, Globus Medical, Inc. (2017) Summary page 4.
- K180480: ATEC Universal Spacer System, Alphatec Spine, Inc. (2018) Summary page 4.
- 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.

## Most influential descendants
- K243461: Calibrate Interbody Systems (2025), 0 descendants of its own

## Recalls of this device
- Dec 15, 2024 · Class II · Z-1065-2025: Complaints have been received regarding post-operative implant collapse.

## Indications for use
The Calibrate CCX Interbody System is indicated for spinal fusion procedures from L1 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. Additionally, the Calibrate CCX Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Calibrate CCX 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 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 lumbar spine.

Source page: https://510kreport.com/device/K232504
Methodology: https://510kreport.com/methodology