The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Medyssey Co. Ltd., Cannulated Pedicle Screws are intended to be used with their respective (e.g. Zenius) top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Cannulated Pedicle Screw implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation. The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod. The Cobalt Chrome Rods are for use with the Zenius or Iliad System. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medyssey Cannulated Pedicle Screws and Cobalt Chrome Rods:

1. Acceptance Criteria and Reported Device Performance

The provided document describes non-clinical (bench) testing for the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The acceptance criteria are implicitly defined by the chosen ASTM standard and the comparison to predicate devices, which means the new device must perform at least as well as the legally marketed predicates.

Acceptance Criteria Category	Specific Criteria (Implicitly from ASTM F1717-04 and Predicate Comparison)	Reported Device Performance
Mechanical Performance	- Static Compression Strength	"Analysis has shown that the proposed screws and rods are equivalent to the predicate devices." (Implies meeting or exceeding predicate performance for all tests listed below)
	- Static Torsion Strength
	- Static Tension Strength
	- Dynamic Compression Performance (Fatigue)
Material Compatibility	- Use of biocompatible materials (Titanium alloy [Ti-6Al-4V ELI], Co-Cr-Mo) conforming to ASTM F 136.	"fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136." and "proposed rods are manufactured from Co-Cr-Mo"
Design Equivalence	- Minor differences in design (cannulation of screws, Co-Cr-Mo rods instead of titanium) do not impact safety or effectiveness.	"Analysis has shown that the proposed screws and rods are equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact number of devices (screws/rods) tested for each non-clinical test (static compression, torsion, tension, dynamic compression). Standard test methodologies for medical devices like ASTM F1717-04 typically require a minimum number of samples for statistically valid results, but these specific numbers are not detailed in this summary.
Data Provenance: The data is from non-clinical (bench) testing performed by Medyssey Co. Ltd. The country of origin of the testing data is not explicitly stated, but Medyssey is a Korean company with a US-based contact for regulatory purposes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study described is non-clinical (bench testing) of physical device properties, not a clinical study involving human patients or expert interpretation of medical data. The "ground truth" here is the measured mechanical performance of the device against established engineering standards and predicate device performance.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is non-clinical (bench testing). Adjudication methods are typically employed in clinical studies or studies involving expert review of medical images/data to resolve discrepancies in interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (spinal pedicle screws and rods), not an AI/software device. Therefore, there is no mention of human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" used for this non-clinical study is:

Engineering Standards and Specifications: Adherence to ASTM F1717-04.
Predicate Device Performance: The mechanical performance of the new device was compared to that of legally marketed predicate devices. The implicit ground truth is that the predicate devices are safe and effective, and therefore, a device demonstrating equivalent or superior mechanical properties would also be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set

This information is not applicable as the study described is non-clinical (bench testing) of a physical device. There is no concept of a "training set" for this type of evaluation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this non-clinical study.

Summary

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JAN 2 5 2013

510(k) Summary

Company:

Medyssey Co. Ltd. 722-3, 4F, Science Tower 4F Donaducheon City Gyeonggido, Korea Tel: 82-31-879-0414 FAX: 82-31-879-0415

Contact:

Michael Kvitnitsky Chief Operating Officer Medyssey Co. Ltd 8001 N. Lincoln Ave. Suite 401 Skokie, IL 60077 Tel: 847-982-0100 FAX: 888-518-9070

Date Prepared: August 9, 2010

Proprietary Name: Iliad Pedicle Screws (formerly Novel) Kora Pedicle Screws (formerly Novel Standard Buttress Thread Screw) Zenius Pedicle Screws Cobalt Chrome Rods

Device Class: Class III

Product Codes: MNI, MNH, NKB

Classification Name: Noncervical, Pedicle Screw System

21 CFR 888.3070 Regulation Number:

Medyssey Co. Ltd, Zenius TM Spinal System K103272 and K110283; the Predicate Device: Medyssey Novel Spinal System K081153, K103147, and K110284; the Synthes Matrix Spine System K092929, K100634 and K100952; the Globus Revere Stabilization System K061202, K081195 K091782, K093294 and K100788; and the Aesculap S MIS Cannulated Pedicle Screw System (K100623, K090657, K071945, K062085 and K032219)

Product Description:

The Medyssey Co. Ltd., Cannulated Pedicle Screws can be used in the posterior plane providing unilateral and bilateral modes of fixation.

The Medyssey Co. Ltd., Cannulated Pedicle Screw Spinal design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a mobile and non-mobile housing component which

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houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod.

The Cobalt Chrome Rods are for use with the Zenius or Iliad System.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd. Cannulated Pedicle Screw implants.

Indications for Use:

The Medyssey Co. Ltd. Zenius, Iliad and Kora Spinal Systems are intended for posterior. noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograff and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Summary of Technological Characteristics Illiad System:

The Medyssey Illiad (formerly Novel) Cannulated Pedicle Screws consists of titaninum pedicie screws and rods. These screws are used with locking screws and instruments from the Illiad (formerly Novel System). Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the same as the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo; whereas, the predicate rods are manufactured from titanium allov. There are no other differences between the proposed and predicate rods.

Medyssey has determined that the minor differences between proposed screws and rods to the predicate devices will not impact the safety or effectiveness of the pedicle screw systems for their intended use. Analysis has shown that the proposed screws and rods are equivalent to the predicate devices.

Summary of Technological Characteristics Zenius System:

The Medyssev Zenuis Cannulated Pedicle Screws consists of a series of titanium pedicle screws and rods. These screws are used with locking screws and instruments from the Zenius System. Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the same as the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo; whereas, the predicate rods are manufactured from titanium alloy. There are no other differences between the proposed and predicate rods.

Summary of Technological Characteristics Kora System:

The Medyssev Kora (formerly Novel Standard Buttress Screw) Cannulated Pedicle Screws consists of a series of titaninum pedicle screws and rods. These screws are used with locking screws and instruments from the Kora System (formerly Novel Standard Buttress Screw. Both the predicate and proposed pedicle screws are made from titanium. The proposed screw designs are the current screw designs the only difference is the cannulation of the screws. The proposed rods are manufactured from Co-Cr-Mo: whereas, the predicate rods are manufactured from titanium alloy. There are no other differences between the proposed and predicate rods.

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Medyssey has determined that the minor differences between proposed screws to the predicate devices will not impact the safety or effectiveness of the pedicle screw systems for their intended use. Analysis has shown that the proposed screws are equivalent to the predicate devices.

ldentification of Legally Marketed Predicate Device:

Documentation was provided, which demonstrates that the subject Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods are substantially equivalent to the predicate devices the Novel and Zenius Spinal System. The proposed Medyssey device has the same indications for use and is manufactured from the same material. The minor differences in the design were evaluated through testing and do not affect the safety and efficacy of the screws for their intended use.

Brief Discussion of Non-Clinical Tests Submitted:

Numerous tests were performed on the Medyssey Cannulated Pedicle Screws and Co-Cr-Mo rods. The tests performed are recommended by the FDA guidance document on spinal system 510(k) submissions and include ASTM F1717-04. List of Tests is below:

Static Compression .
Static Torsion .
Static Tension .
Dynamic Compression .

Conclusions from Non-Clinical Tests:

Based on the testing and comparison analysis to the predicate devices provided in this premarket notification submission, Medyssey believes that the subject Cannulated Pedicle Screws and Co-Cr-Mo rods are substantially equivalent to the Novel and Zenius Screws.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human services.

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

Letter dated: January 25, 2013

Medyssey Company Limited % Mr. Michael Kvitnitsky Chief Operating Officer 8001 North Lincoln Avenue, Suite 401 Skokie, Illinois 60077

Re: K121670

Trade/Device Name: Zenius, Iliad and Kora Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: January 16, 2013 Received: January 22, 2013

Dear Mr. Kvitnitsky:

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.

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Page 2 - Mr. Michael Kvitnitsky

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/ReportalProblem/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

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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· Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Medyssey Zenius, Iliad and Kora Systems

Indications for Use:

Prescription Use × (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

RonaldiPhylean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121670

Page 1 of 1

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.