# K190584: CAYMAN LP Plate System

- Pathway: 510(k) (Traditional)
- Applicant: K2m, Inc.
- Decided: May 15, 2019 after 70 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: 8 generations back to K990745 (1999). 45 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080302: Cayman Buttress Plate System, K2m, Inc. (2008) Summary page 4.
- K181063: Kestrel™ Buttress Plate System, Innovasis, Inc. (2018) Summary page 4.
- K142699: LITe Plate System, Stryker Corporation (2014) Summary page 4.

## Most influential descendants
- K242361: OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (2024), 1 descendant of its own
- K253545: Vulcan Spinal System (2026), 0 descendants of its own

## Indications for use
The CAYMAN LP Plate System is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Source page: https://510kreport.com/device/K190584
Methodology: https://510kreport.com/methodology