# K113802: Escalate Laminoplasty System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Spine
- Decided: Apr 16, 2012 after 115 days
- Product code: NQW (Orthosis, Spine, Plate, Laminoplasty, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K761228 (1976). 12 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050082: Centerpiece Plate Fixation System, Medtronic Sofamor Danek, Inc. (2005) Summary page 1.
- K032534: Synthes Afs, Synthes Spine (2004) Summary page 1.

## Most influential descendants
- K222684: XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi (2023), 4 descendants of its own
- 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
- K240872: Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (2024), 1 descendant of its own
- K181717: Life Spine Laminoplasty System (2018), 1 descendant of its own
- K253545: Vulcan Spinal System (2026), 0 descendants of its own

## Indications for use
The Escalatem Laniinoplasty System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The system is intended to hold the lamina open following a laminoplasty procedure.

Source page: https://510kreport.com/device/K113802
Methodology: https://510kreport.com/methodology