# K072407: Bodyform Thoracic Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Spine, LLC
- Decided: Dec 21, 2007 after 116 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955348 (1996). 5 ancestors in all.
87 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983622: Bodyform Thoraco-Lumbar Fixation System, Theken Surgical,Llc (1998) Summary page 1.
- K020244: Synthes Thoracolumbar Spine Locking Plate (TSLP), Synthes Spine (2002) Summary page 1.
- K041592: Coral Spinal System, Theken Surgical (2004) Summary page 1.

## Most influential descendants
- 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
- K181347: Aries® Lumbar Interbodies (2018), 24 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own

## Indications for use
The BodyFormTM Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the: disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis. The BodyFormT M Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from Ti to LI.

Source page: https://510kreport.com/device/K072407
Methodology: https://510kreport.com/methodology