# K101993: Viper System, Expedium System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: Dec 7, 2010 after 145 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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: 12 generations back to K853033 (1985). 68 ancestors in all.
162 later devices descend from it; 6 cite it directly.
0 of 231 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 1.
- K090648: Viper 2 System, Depuy Spine, Inc. (2009) Summary page 1.
- K051024: Expedium Spine System, Depuy Spine, Inc. (2005) Summary page 1.
- K063156: Modification to Expedium Spine System, Depuy Spine, Inc. (2006) Summary page 1.
- K063741: Expedium Spine System, Depuy Spine, Inc. (2007) Summary page 1.
- K080313: Modification to Expedium Spine System, Depuy Spine, Inc. (2008) Summary page 1.

## Most influential descendants
- K131802: Expedium, Viper. Viper 2 Spine System (2013), 139 descendants of its own
- K181677: Kodiak Spinal Fixation System (2018), 70 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own
- K203056: Invictus™ Spinal Fixation System (2020), 61 descendants of its own
- K203742: IdentiTi ALIF Standalone Interbody System (2021), 59 descendants of its own

## Recalls of this device
- Nov 7, 2012 · Class II · Z-0705-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0707-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0706-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0708-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0709-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0710-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0712-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the p
- Nov 7, 2012 · Class II · Z-0713-2013: Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the po

## Indications for use
The EXPEDIUM and VIPER Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM and VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients. When used in a percutaneous approach with MIS Instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Source page: https://510kreport.com/device/K101993
Methodology: https://510kreport.com/methodology