# K091253: Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate, Model 1208-41FXXS

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Jun 4, 2009 after 36 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: 4 generations back to K983583 (1998). 19 ancestors in all.
73 later devices descend from it; 1 cites 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)
- K081380: Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws, K2m, Inc. (2008) Summary page 1.
- K043548: Blackstone Unity Anterior Lumbar Plate Fixation System, Blackstone Medical, Inc. (2005) Summary page 1.
- K020244: Synthes Thoracolumbar Spine Locking Plate (TSLP), Synthes Spine (2002) Summary page 1.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 1.
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.
- K080773: Thor Anterior Plating System, Stryker Spine (2008) Summary page 1.
- K072407: Bodyform Thoracic Fixation System, Theken Spine, LLC (2007) Summary page 1.

## Most influential descendants
- 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
- K191354: Ti3Z Cervical Interbody System (2019), 13 descendants of its own

## Indications for use
The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (Ti-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Source page: https://510kreport.com/device/K091253
Methodology: https://510kreport.com/methodology