# K123476: Mega 5.5 Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Lsk Biopartners, Inc.
- Decided: Jan 8, 2013 after 56 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: 4 generations back to K951116 (1995). 34 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072436: Mega Spine System, Bk Meditech, Co., Ltd. (2007) Summary page 1.
- K031595: U & I America Spinal Hook System, U&I Corp., America (2003) Summary page 1.
- K071857: Delta Spinal Fusion System, Jemo Spine, LLC (2007) Summary page 1.
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws, Depuyacromed (2003) Summary page 1.

## Most influential descendants
- K171497: Mikron Spinal Fixation System (2017), 4 descendants of its own
- K241657: MSFX Mikron Spinal Fixation System (2024), 3 descendants of its own
- K243946: EffortMed Spinal Fixation System (2025), 1 descendant of its own
- K254247: Osteomni Spinal Fixation System (2026), 0 descendants of its own
- K250092: HC Biologics Osteopoint Spinal Fixation System (2025), 0 descendants of its own

## Indications for use
The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-SI vertebra in skeletally mature patients receiving fusion by autogeneous 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 Mega 5.5 Spine 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 turnor and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K123476
Methodology: https://510kreport.com/methodology