# K223719: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System

- Pathway: 510(k) (Special)
- Applicant: Aegis Spine, Inc.
- Decided: Jan 11, 2023 after 30 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K853033 (1985). 135 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 139 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221050: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System, Aegis Spine, Inc. (2022) Summary page 5.
- K210035: ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System, Aegis Spine (2021) Summary page 5.
- K143271: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2015) Summary page 5.
- K190425: CastleLoc-P Anterior Cervical Plate System, L&K BIOMED Co., Ltd. (2019) Summary page 5.
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 5.
- K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System, Zimmer Spine, Inc. (2015) Summary page 5.

## Most influential descendants
- K231839: CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System (2023), 2 descendants of its own
- K261112: CastleLoc-P Anterior Cervical Plate System (2026), 0 descendants of its own
- K251940: PathLoc Lumbar Plate System (2026), 0 descendants of its own

## Indications for use
The Paeon Anterior Cervical Plate System is intended for anterior to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudoarthrosis, • failed previous fusion, • spinal stenosis. The Elatus Lumbar Plate System is indicated for use via the anterior, lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K223719
Methodology: https://510kreport.com/methodology