# K222203: DualXSLIM (R) T/PLIF

- Pathway: 510(k) (Traditional)
- Applicant: Amplify Surgical, Inc.
- Decided: Oct 18, 2022 after 85 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: 21 generations back to K841189 (1984). 334 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 338 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181397: DualX, Innovasive, Inc. (2018) Summary page 4.
- K171633: NuVasive TLX Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.
- K152475: FORZA PTC Spacer System, Orthofix, Inc. (2016) Summary page 5.

## Most influential descendants
- K231275: Exceed™ Biplanar Expandable Interbody System (2023), 2 descendants of its own
- K261159: Exceed® Biplanar Expandable Interbody System (2026), 0 descendants of its own
- K243816: Testa TP Pivoting Spacer System (2025), 0 descendants of its own

## Indications for use
The Amplify Surgical DualXSLIM® T/PLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The devices are to be used in patients who have had at least six months of non-operative treatment. The Amplify Surgical DualXSLIM® T/PLIF is indicated for unilateral or bilateral implantation. The DualXSLIM® T/PLIF implants are intended for single use.

Source page: https://510kreport.com/device/K222203
Methodology: https://510kreport.com/methodology