# K223776: PEEK Spinal Infusion Cage

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
- Decided: Mar 3, 2023 after 77 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: 10 generations back to K841189 (1984). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 4.

## Indications for use
The PEEK Spinal Fusion Cage is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K223776
Methodology: https://510kreport.com/methodology