# K231840: CastleLoc-S Posterior Cervical Fixation System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Jul 20, 2023 after 28 days
- Product code: NKG (Posterior Cervical Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3075
- 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.
No later device cites it as a predicate yet.
1 of 136 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143278: LnK Posterior Cervical Fixation System, L&K BIOMED Co., Ltd. (2015) Summary page 4.
- K120879: Lexus Cervical Fixation System, L&K BIOMED Co., Ltd. (2012) Summary page 4.
- K103414: Venus Cervical Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 4.
- K162136: CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System, L&K BIOMED Co., Ltd. (2016) Summary page 4.
- K200793: LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System, L&K BIOMED Co., Ltd. (2020) Summary page 4.
- 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 4.
- 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 4.

## Indications for use
The CastleLoc-S Posterior Cervical Fixation System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The CastleLoc-S Posterior Cervical Fixation System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System and AccelFix Spinal Fixation System via rod to rod connector and transitional rod.

Source page: https://510kreport.com/device/K231840
Methodology: https://510kreport.com/methodology