# K983622: Bodyform Thoraco-Lumbar Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Theken Surgical,Llc
- Decided: Dec 30, 1998 after 76 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
No predicates in its family tree.
328 later devices descend from it; 2 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Z-Plate Anterior Fixation System (Sofamor-Danek): named in the summary without a submission number
- (no number) University Plate Titanium Anterior System (Acromed): named in the summary without a submission number
- (no number) Anterior Thoracolumbar Locking Plate (Synthes): named in the summary without a submission number

## Most influential descendants
- K002824: Macs Modular Anterior Construct System (2001), 254 descendants of its own
- K032059: Modification to Macs Modular Anterior Construct System (2003), 250 descendants of its own
- K070387: Expedium Spine System (2007), 248 descendants of its own
- K102249: Expedium Spine System (2010), 218 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own

## Indications for use
The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by: 1. Trauma. 2. Tumor, 3. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. 4, Aaterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis. The instrumentation is designed for leveis of fixation from T10 to L4.

Source page: https://510kreport.com/device/K983622
Methodology: https://510kreport.com/methodology