# K200267: LOSPA® IS™ Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Mar 6, 2020 after 32 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 15 generations back to K853033 (1985). 266 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092076: Aegis & Aegis II Spinal System, Corentec Co., Ltd. (2010) Summary page 5.
- K071373: Stryker Spine Xia Iii Spinal System, Stryker Spine (2007) Summary page 5.
- K083393: Xia 3 Spinal System, Stryker Spine (2009) Summary page 6.
- K091291: Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod, Stryker Spine (2009) Summary page 6.
- K143363: VENUS Spinal Fixation System, L&K BIOMED Co., Ltd. (2015) Summary page 6.
- K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System, Spinevision S.A. (2016) Summary page 6.
- K110283: Zenius Spinal System, Medyssey Co, Ltd. (2011) Summary page 6.
- K142185: Expedium Verse Spine System, Depuy Spine, Inc. (2014) Summary page 6.
- K183117: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2018) Summary page 6.
- K161766: PathLoc-L MIS Spinal System, L&K BIOMED Co., Ltd. (2016) Summary page 6.

## Most influential descendants
- K240180: Orthopeasia Spinal Fixation System (2024), 0 descendants of its own

## Indications for use
The LOSPA IS Spinal Fixation Systems are 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used as an anterior screw fixation system, The LOSPA Spinal Fixation Systems are indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K200267
Methodology: https://510kreport.com/methodology