# K073437: Thor Anterior Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Feb 13, 2008 after 69 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983583 (1998). 5 ancestors in all.
102 later devices descend from it; 1 cites it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 1.
- K994347: Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K001844: Modification to Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 1.
- K012870: Xia Stainless Steel System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Most influential descendants
- K080773: Thor Anterior Plating System (2008), 101 descendants of its own
- K091253: Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate, Model 1208-41FXXS (2009), 73 descendants of its own
- K131533: Cayman MI Plate System (2013), 72 descendants of its own
- K172941: CASCADIA Interbody System (2018), 52 descendants of its own
- K142699: LITe Plate System (2014), 46 descendants of its own

## Recalls of this device
- Oct 2, 2009 · Not classified · Z-0426-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0427-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0430-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0435-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0441-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0442-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0447-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0453-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0431-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0432-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0433-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0434-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0440-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0454-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0424-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0425-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0436-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0439-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0443-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0445-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0446-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0449-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0428-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0450-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0451-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0452-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0429-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0437-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0438-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0444-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t
- Oct 2, 2009 · Not classified · Z-0448-2010: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause t

## Indications for use
The Stryker Spine THOR TM Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels. The Styker Spine THORTM Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-Si). THOR"4 Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Pseudoarthrosis; * Spondylolysis; * Spondylolisthesis; * Trauma (i.e., fracture or dislocation); * Deformities (i.e., scoliosis or lordosis) * Spinal Stenosis; and * Failed Previous Fusion.

Source page: https://510kreport.com/device/K073437
Methodology: https://510kreport.com/methodology