# K020244: Synthes Thoracolumbar Spine Locking Plate (TSLP)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Apr 22, 2002 after 88 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.
117 later devices descend from it; 7 cite it directly.
0 of 118 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 no predicate by number.

## Most influential descendants
- K072407: Bodyform Thoracic Fixation System (2007), 87 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
- K181347: Aries® Lumbar Interbodies (2018), 24 descendants of its own

## Indications for use
The Synthes TSLP System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1 — L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Source page: https://510kreport.com/device/K020244
Methodology: https://510kreport.com/methodology