# K162801: CastleLoc Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: L&K BIOMED Co., Ltd.
- Decided: Nov 3, 2016 after 29 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K000319 (2000). 21 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103085: Venus Basic Spinal Fixation System, L&K BIOMED Co., Ltd. (2011) Summary page 4.

## Most influential descendants
- K173645: JASPER Spinal Fixation System (2018), 3 descendants of its own
- K182059: Prase MIS Spinal System (2018), 2 descendants of its own
- K190762: The JASPER Spinal Fixation System II (2019), 1 descendant of its own
- K232292: Peridot-EX Expandable Intervertebral Body Fusion System (2023), 0 descendants of its own

## Indications for use
The CastleLoc Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the CastleLoc Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K162801
Methodology: https://510kreport.com/methodology