# K100061: Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX

- Pathway: 510(k) (Special)
- Applicant: K2m, Inc.
- Decided: Feb 12, 2010 after 32 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: 6 generations back to K990745 (1999). 21 ancestors in all.
73 later devices descend from it; 1 cites it directly.
0 of 95 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.
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 1.
- K031100: Synthes Ventrofix Mis System, Synthes (Usa) (2004)
- K062407: Gateway Thoracolumbar Plate System, Globus Medical, Inc. (2006) Summary page 1.
- K922543: Z-Plate Anterior Fixation System, Sofamor Danek Mfg., Inc. (1993) 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 PLATES are 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 - SI1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograph 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 laminiectomy.

Source page: https://510kreport.com/device/K100061
Methodology: https://510kreport.com/methodology