# K081380: Thoracolumbar, Lumbar and Sacral Plates and 6.0 and 7.0 MM Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: Nov 19, 2008 after 187 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.
75 later devices descend from it; 4 cite it directly.
0 of 76 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) Blackstone Medical Unity Anterior Lumbar Plate Fixation System: named in the summary without a submission number
- (no number) Synthes Thoracolumbar Spine Locking Plate: named in the summary without a submission number
- (no number) Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System: named in the summary without a submission number
- (no number) Sofamor Danek Z-Plate: named in the summary without a submission number

## Most influential descendants
- K100061: Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX (2010), 73 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 Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 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) idiopathic thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele, k) neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity.

Source page: https://510kreport.com/device/K081380
Methodology: https://510kreport.com/methodology