# K221687: Pegasus-X Expandable PLIF System

- Pathway: 510(k) (Traditional)
- Applicant: GS Medical Co., Ltd.
- Decided: Jul 27, 2022 after 47 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: 12 generations back to K841189 (1984). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 5.
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 5.

## Indications for use
GS Medical's Pegasus-X Expandable PLIF System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). The Pegasus-X Expandable PLIF Cage is to be combined with internal supplemental fixation cleared for use in the lumbar spine.

Source page: https://510kreport.com/device/K221687
Methodology: https://510kreport.com/methodology