# K110633: Lancer Pedicle Screw System

- Pathway: 510(k) (Special)
- Applicant: Spinal Solutions, LLC
- Decided: Dec 15, 2011 after 286 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K990745 (1999). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033826: Orthopedic Alliance Spine System, Orthopedic Alliance, LLC (2004) Summary page 1.
- K092420: KRD1 Pedicle Screw System, Spinefrontier, Inc. (2009) Summary page 1.

## Recalls of this device
- Feb 20, 2013 · Class II · Z-1415-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1413-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1410-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1412-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1416-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1411-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1409-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev
- Feb 20, 2013 · Class II · Z-1414-2013: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to ev

## Indications for use
The Lancer Pedicle Screw 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kylphosis and loss of stability due to tumors. When used as a pedicle screw system, the Lancer Pedlicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L_5-S1 vertebrae 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.

Source page: https://510kreport.com/device/K110633
Methodology: https://510kreport.com/methodology