K Number

Device Name

SpineJack Expansion Kit

Manufacturer

Stryker Corporation

Date Cleared

2020-10-20

(60 days)

Product Code

NDN

Regulation Number

888.3027

Intended Use

The SpineJack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex® HV bone cement.

Device Description

The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a validated Stryker PMMA bone cement, such as Stryker VertaPlex® or VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack but are sold separately.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181262

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant and bone cement system for vertebral fracture reduction, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as an implanted fracture reduction system intended to reduce painful osteoporotic vertebral compression fractures, which directly treats a medical condition.

Diagnostic

The device is described as an "implanted fracture reduction system" used to reduce vertebral compression fractures, indicating a therapeutic or treatment-oriented function rather than a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states it is an "implanted fracture reduction system" and describes physical components (implants, bone cement).

IVD (In Vitro Diagnostic)

Based on the provided information, the SpineJack® Expansion Kit is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to reduce painful osteoporotic vertebral compression fractures. This is a therapeutic intervention performed directly on the patient's body.
Device Description: The device is an implanted fracture reduction system. It is physically inserted into the vertebral body.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SpineJack does not interact with or analyze such specimens.

The SpineJack is a surgical implant used for a therapeutic purpose, not a diagnostic test performed on a sample outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

NDN

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vertebral compression fractures

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)

Non-clinical testing was deemed not required for this 510(k). The SpineJack implant was previously tested to be non-pyrogenic.
Clinical testing was deemed not required for this 510(k).
Clinical literature, post-market surveillance data and a risk analysis per ISO 14971 were used in support of the subject modification.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K181262

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Summary

October 20, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Stryker Corporation Kristi Ashton Senior Staff RA Specialist 1926 Stryker Way Kalamazoo, Michigan 49002

Re: K202393

Trade/Device Name: SpineJack® Expansion Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: August 18, 2020 Received: August 21, 2020

Dear Kristi Ashton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K202393

Device Name

SpineJack® Expansion Kit (Spinejack ®)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. Above the word "stryker" is the alphanumeric code "K202393". The word "stryker" is in all lowercase letters and is the most prominent element in the image. The background is plain white.

510(K) SUMMARY

510(K) SUMMARY: SPINEJACK® EXPANSION KIT
Submitter:	Stryker Instruments
1941 Stryker Way
Kalamazoo, MI 49002 USA
Contact Name: Kristi Ashton
Title: Senior Staff RA Specialist
Phone: 269-800-1692
E-mail: Kristi.Ashton@Stryker.com
Date prepared:	October 20, 2020
Subject Device Trade Name:	SpineJack Expansion Kit (SpineJack)
Common Name:	Implantable Fracture Reduction System
Classification Name:	Cement, Bone, Vertebroplasty
Product Code:	NDN
Regulatory Class:	II
Regulation Name:	Polymethylmethacrylate (PMMA)
Regulation Number:	21 CFR 888.3027
Predicate Device:	SpineJack Expansion Kit (SpineJack), K181262
Device Description:	The SpineJack Expansion Kit (herein referred to as “SpineJack”) is an
implanted fracture reduction system, intended to reduce vertebral
compression fractures. The SpineJack Expansion Kit is used with the
Preparation Kit. The Expansion Kit is available in three sizes, to
accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and
Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and a
validated Stryker PMMA bone cement, such as Stryker VertaPlex® or
VertaPlex® HV Bone Cement, is injected at a low pressure to stabilize
the restored vertebral body. The bone cement and its delivery system are
intended to be used with the SpineJack but are sold separately.
Indications for Use	The SpineJack® Expansion Kit is indicated for use in the reduction of
painful osteoporotic vertebral compression fractures. It is intended to be
used in combination with Stryker Vertaplex® and Vertaplex® HV Bone
Cement.
Non-Clinical Testing	Non-clinical testing was deemed not required for this 510(k). The
SpineJack implant was previously tested to be non-pyrogenic.
Clinical Testing	Clinical testing was deemed not required for this 510(k)
Other Evidence:	Clinical literature, post-market surveillance data and a risk analysis per
ISO 14971 were used in support of the subject modification.
Summary of Technological Characteristics

Table 1 below details the comparisons between the subject and predicate devices.

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Table 1 Comparison of Regulatory and Technical Characteristics
Element of
Comparison	SpineJack
Subject Device	SpineJack
Predicate Device	Comparison
Indications for Use	The SpineJack®
Expansion Kit is
indicated for use in the
reduction of painful
osteoporotic vertebral
compression fractures. It
is intended to be used in
combination with
Stryker Vertaplex® and
Vertaplex® HV bone
cements.	The SpineJack®
Expansion Kit is
indicated for use in the
reduction of painful
osteoporotic vertebral
compression fractures.
It is intended to be used
in combination with
Stryker Vertaplex® and
Vertaplex ® HV bone
cements.	Identical
Contraindications	Patients presenting with
type B or C traumatic
vertebral fractures
according to the Magerl
classification.	Patient presenting with
traumatic fractures
(Reference IFU for full
list of contraindications)	Different-It is proposed
that Type A trauma
fractures are removed
from the list of
contraindications for
SpineJack. Clinical
literature, post-market data
and a risk assessment per
ISO 14971 were provided
to support the safety of
this modification. This
change does not raise new
types of safety and
effectiveness questions
regarding the use of the
subject device.
Contact	Implantable	Implantable	Identical
Material	Ti-6Al-4V with PMMA
(cement injected)	Ti-6Al-4V with PMMA
(cement injected)	Identical
Length (mm)	14 - 20 (plate length)	14 - 20 (plate length)	Identical
Width (mm)	4 - 6	4 - 6	Identical
Height pre and post
expansion (mm)	4 - 20 (Surgeon
determined)	4 - 20 (Surgeon
determined)	Identical
Expansion Mechanism	Plastic deformation of
struts, continuous	Plastic deformation of
struts, continuous	Identical
Number of Implants
Typically Used	1-2 per patient	1-2 per patient	Identical

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SpineJack has the same intended use, fundamental scientific technology, principle of operation, and mode of action as the predicate device. An evaluation of clinical literature, post-market data in US and Europe and risk per ISO 14971 provide the evidence to support the removal of Type A trauma fractures from the contraindications. The use of post-market data from Europe demonstrates the history of safe and effective use of the Conclusion product in Type A traumatic fractures since 2008. The evaluation of the post-market data, use history and a clinical literature review provide established evidence which confirm that the subject modification does not raise new types of safety and effectiveness questions regarding the use of the subject device. Therefore, it is proposed that the subject SpineJack is equivalent to the predicate device.