K Number
K113802
Device Name
ESCALATE LAMINOPLASTY SYSTEM
Manufacturer
Date Cleared
2012-04-16

(115 days)

Product Code
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Escalate™ Laminoplasty 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.
Device Description
The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.
More Information

No
The description focuses on the mechanical components and intended use of a surgical implant system, with no mention of AI or ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.

Yes

Explanation: The device is intended to hold the lamina open following a laminoplasty procedure, which is a therapeutic intervention to treat a medical condition in the spine.

No

The device is an implantable system designed to hold the lamina open after a laminoplasty procedure, not to diagnose a medical condition.

No

The device description explicitly states it consists of implants (expandable laminoplasty plate, hinge plate, bone screws) and instruments, all made of Titanium alloy. This indicates a physical hardware device, not software only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for a surgical procedure (laminoplasty) to hold the lamina open in the spine. This is a physical intervention on the body.
  • Device Description: The device consists of implants (plates, screws) and instruments used in surgery. These are physical devices used to modify the body's structure.
  • Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.

The information provided clearly describes a surgical implant system, not a diagnostic test performed on in vitro samples.

N/A

Intended Use / Indications for Use

The Escalate™ Laminoplasty 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.

Product codes

NQW

Device Description

The Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lower cervical and upper thoracic spine (C3-T3)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance testing conducted to demonstrate substantial equivalence to the predicate devices included: static and dynamic compression loading (modified ASTM 1717-11a), screw driving insertion torque (ASTM F543-07), screw removal torque (ASTM F543), screw torque to failure (ASTM F543-07), and axial screw pull-out (ASTM F543-07). The performance data verifies that the subject devices are substantially equivalent to the predicate devices currently on the market and have met all mechanical test requirements based on the engineering rationale.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Medtronic Centerpiece™ Plate Fixation System (K050082), Synthes Arch™ Fixation System (K032534)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.

0

KII3802

Stryker Spine Escalate™ Laminoplasty System

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Traditional 510(k) Premarket Notification

APR 1 6 2012

510(k) Summary: Escalate™ Laminoplasty System
Submitter:Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401
Contact PersonMs. Simona Voic
Sr. Regulatory Affairs Project Manager
Phone: 908-522-3482/ Fax: 201-760-8482
Email: simona.voic@stryker.com
Date PreparedApril 13, 2012
Trade NameEscalate™ Laminoplasty System
Proposed ClassClass II
Classification Name
and NumberSpinal interlaminal fixation orthosis, 21 CFR §888.3050
Product CodeNQW
Predicate DevicesThe Escalate™ Laminoplasty System was shown to be substantially
equivalent to the devices listed below:
Medtronic Centerpiece™ Plate Fixation System (K050082) Synthes Arch™ Fixation System (K032534)
Device DescriptionThe Escalate™ System consists of a comprehensive set of implants and instruments designed for a systematic approach to cervical laminoplasty procedures. The system features an expandable laminoplasty plate, a hinge (“Base”) plate, bone screws for fixation, and a set of instrumentation to assist in the implantation and removal of the implants. The plates have screw holes, which allow for attachment to the vertebral body. The screws to be used with the plates are available in a variety of lengths and diameters and are designed to match the anatomical requirements. The Escalate™ Laminoplasty plates and screws are manufactured from Titanium alloy and will be provided non-sterile.
510(k) Summary: Escalate™ Laminoplasty System
Intended Use/
Indications for UseThe Escalate™ Laminoplasty 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.
Summary of the
Technological
CharacteristicsThe technological characteristics of the Escalate™ Laminoplasty
System are the same or similar to the predicate devices commercially
distributed.
Performance DataThe performance testing conducted to demonstrate substantial
equivalence to the predicate devices included: static and dynamic
compression loading (modified ASTM 1717-11a), screw driving
insertion torque (ASTM F543-07), screw removal torque (ASTM F543),
screw torque to failure (ASTM F543-07), and axial screw pull-out
(ASTM F543-07).
The performance data verifies that the subject devices are substantially
equivalent to the predicate devices currently on the market and have met
all mechanical test requirements based on the engineering rationale.
Substantial
EquivalenceThe Escalate™ Laminoplasty System was determined to be
substantially equivalent to the above referenced predicate devices. The
subject system does not present any new issues of safety and
effectiveness.
ConclusionThe Escalate™ Laminoplasty System is substantially equivalent to its
predicate devices. Mechanical testing as well as other supporting
information sufficiently demonstrates the substantial equivalence of the
Escalate™ Laminoplasty System to the other laminoplasty fixation
systems. Based on this information, the subject system does not raise
any new issues regarding the safety or efficacy.

1

Stryker Spine Escalate™ Laminoplasty System

.

.

Traditional 510(k) Premarket Notification

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stryker Spinc % Ms. Simona Voic Senior Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K113802

Trade/Device Name: Escalate™ Laminoplasty System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: March 22, 2012 Received: March 23, 2012

APR 1 6 2012

Dear Ms. Voic:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2 - Ms. Simona Voic

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

OR

Enclosure

4

Stryker Spine Escalate™ Laminoplasty System

Traditional 510(k) Premarket Notification

Indications for Use

510(k) Number (if known): K | 113802

Device Name: Stryker Spine Escalate™ Laminoplasty System

Indications For Use:

The Escalate™ Laminoplasty 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113802