# K211873: PSX Interbody System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Aug 10, 2021 after 54 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: 26 generations back to K841189 (1984). 534 ancestors in all.
11 later devices descend from it; 2 cite it directly.
1 of 546 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) 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.
- K112648: Asfora Bullet Cage, Medical Designs, LLC (2012) Summary page 4.
- K193203: MOJAVE Expandable Interbody System, K2m, Inc. (2020) Summary page 4.
- K160959: Xsert Lumbar Expandable Interbody System, X-Spine Systems, Inc. (2016) Summary page 4.
- K090782: Novel Alif Spinal Spacer System, Alphatec Spine, Inc. (2009) Summary page 4.
- K191311: ATEC Lateral Interbody System, Alphatec Spine, Inc. (2019) Summary page 4.

## Most influential descendants
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (2023), 7 descendants of its own
- 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

## Indications for use
The PSX Interbody System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the lumbosacral spine (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 PSX 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 lumbar spine.

Source page: https://510kreport.com/device/K211873
Methodology: https://510kreport.com/methodology