# K132644: Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa IS Rod- Pre Bent (Standard & BU

- Pathway: 510(k) (Special)
- Applicant: Corentec Co., Ltd.
- Decided: Sep 19, 2013 after 24 days
- Product code: MNI (Orthosis, Spinal Pedicle 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: 14 generations back to K853033 (1985). 182 ancestors in all.
No later device cites it as a predicate yet.
0 of 183 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 2.
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 3.
- K081952: Synergy Spinal System (6.35 Polaris), Biomet Spine (2008) Summary page 3.
- K022623: 5.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System), Depuyacromed (2002) Summary page 3.
- K964024: Depuy Motech Titanium Moss Miami Spinal System, Depuy, Inc. (1997) Summary page 3.
- K031585: U&I, Optima, Spinal System, U&I Corp., America (2003) Summary page 3.
- K071880: Optima ZS Transition Screw, Zimmer Spine, Inc. (2007) Summary page 3.
- K983904: Rogozinski Spinal Rod System, United States Surgical, A Division of Tyco Healthc (1998) Summary page 3.
- K102488: Apex Spine System W/ Cocr Rods, Spinecraft, LLC (2010) Summary page 3.
- K092624: Firebird Spinal Fixation System, Blackstone Medical, Inc. (2009) Summary page 3.
- K130877: Expedium Spine System, Medos International SARL (2013) Summary page 3.

## Indications for use
The LOSPA IS Spinal 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 spandylolisthesis (grades 3 and 4) of the L5-SI 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 IS Spinal Systems are indicated for patients with degener'ative 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, pseudaribrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K132644
Methodology: https://510kreport.com/methodology