The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).

Device Description

The Zenius 146 Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.

AI/ML Overview

The provided text describes a 510(k) summary for a spinal system and its modification, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical or even extensive non-clinical testing beyond basic mechanical and sterilization validation.

This document specifically states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system." The purpose of this submission was for the clearance of the redesign of the custom sterilization trays, not for assessing the clinical performance or efficacy of the spinal system itself beyond its substantial equivalence to the previously cleared predicate.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text, with clear limitations:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Mechanical Testing: Adherence to ASTM F 1717-04 standards for: - Static Compression Bending - Static Tension Bending - Static Torsional Testing	All testing performed per ASTM F 1717-04. (However, this particular submission did not include these tests for the redesigned sterilization trays, as they were not considered "worst case" for mechanical performance of the implant itself. The predicate device and previous submissions would have covered this.)
Sterilization Validation: Achieve a Sterility Assurance Level (SAL) equal to at least 1 x 10⁻⁶ according to AAMI ST77 and AAMI ST79 guidelines for redesigned sterilization trays.	Validation was satisfactorily performed on the re-designed sterilization trays, achieving the required SAL.
Material: Fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.	Explicitly stated as conforming to ASTM F 136.
Substantial Equivalence: To predicate device Zenius™ Spinal System (K093104) and Zenius™ Spinal System (K103272) for performance, safety & effectiveness requirements.	Found substantially equivalent.

Important Note: The document focuses on demonstrating substantial equivalence to a previously cleared device, particularly for a modification to sterilization trays. It does not present new performance data for the implant itself beyond the scope of that modification.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Mechanical Testing: Not specified for this submission, as the mechanical tests (ASTM F 1717-04) were already performed for the predicate device, and the current submission primarily concerned sterilization trays. For the sterilization validation, the sample size and provenance are not detailed in this summary; it just states it was "satisfactorily performed."
Clinical Data: No clinical tests were conducted for either the subject system or the predicate system (as stated in the document).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical tests were performed, and thus no expert ground truth was established from clinical data for this submission. The "ground truth" for mechanical testing would be the ASTM standards, and for sterilization, the AAMI guidelines.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no clinical tests were performed and no human adjudication of results is mentioned for the non-clinical tests.

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 MRMC comparative effectiveness study was done. This device is a mechanical spinal implant, not an AI-assisted diagnostic or therapeutic system.

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

Not applicable. This device is a mechanical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For mechanical properties: ASTM F 1717-04 standards.
For material properties: ASTM F 136 standard for titanium alloy.
For sterility: AAMI ST77 and AAMI ST79 guidelines.
No clinical ground truth (expert consensus, pathology, outcomes data) was used or generated for this specific submission because no clinical studies were performed.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established:

Not applicable. This is a mechanical device, not a machine learning algorithm.

Summary

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510(k) SUMMARY

MAY 1 9 2011

"Special 510 (K): Device Modification" Premarket Notification: Zenius™ Spinal System

1. Submitter/Sponsor:

Medyssey Co. Ltd. Patrick D. Moore, Official US Correspondent 722-3, 4F. Science Tower, Jihaeng-dong, Dongducheon-city, Gyeonggi-do, Korea

Contact person:

Patrick D. Moore Official US Correspondent Medyssey Co. Ltd. 6170 South 380 West, Suite 200. Murray, Utah. 84107 Tel. 801-266-4811, Fax. 801-266-4363; E-Mail: pdmoore@jemospine.com

Date Prepared:

January 27, 2011

2. Device Name:

Classification Name: Pedicle Screw Spinal System Common/Generic Name: Pedicle Screw Spinal System Medyssey Co., Ltd. Zenius TM Spinal System Trade Name:

3. Device Classification(s):

Pedicle Screw Spinal System MNI, MNH 21 CFR § 888.3070 .

4. Predicate Device:

Medyssey Co., Ltd., Zenius Spinal System (K093104) Medyssey Co., Ltd., ZeniusM Spinal System (K103272)

5. Device Description:

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Zenius "" Spinal System implants.

6. Intended Use:

The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation

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device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adiunct 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 obiective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Comparison with predicate device: The Modified Zenius™ Spinal System is substantially equivalent to the currently marketed Zenius™ Spinal System. When considered for Posterior applications, both the Modified Zenius 100 Spinal System and the Zenius™ Spinal System worst case constructs consist of the same universal housing containing the same pre-assembled pedicle screw and set screw. Both systems use the same vertical rods which are both placed into the housing. The same set screws are subsequently tightened onto the rod, providing a completed implant assembly.

The principles of operation for the subject Zenius™ Spinal System device, and the cited predicate technologies are same. That is, each of these products employs the same indications for use, contraindications for use, warnings and precautions within labeling. The principles of operation of the subject device are directly equivalent to those of the cited predicates cleared by the Agency and currently being marketed.

The design and development process of the manufacturer of subject system and Predicate system conforms to 21 CFR part 820, Quality System Regulation. The subject and predicate device was evaluated/tested per established requirements.

The subject/predicate device underwent mechanical testing included Static Compression Bending; Static Tension Bending; and Static Torsional Testing. All testing performed per ASTM F 1717-04. However, the purpose of the submission is the clearance of the redesign of the custom sterilization trays, therefore the new modified custom dedicated sterilization tray(s) (are not worst case) and therefore not subject to ASTM F 1717-04 additional testing. However, a new Sterilization Validation according to AAMI ST77 and AAMI ST79 guidelines to achieve a degree of Sterility Assurance Level (SAL) equal to at least 1 x 10°; is required, and was satisfactorily preformed on the re-designed sterilization trays; the validation summary is presented within the body of this submission. Clinical tests: No clinical tests conducted on either the subject system nor the predicate system.

Conclusion: The subject device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Medyssey Co., Ltd. % Mr. Patrick D. Moore 6170 South 380 West, Suite 200 Murray, Utah 84107

MAY 1 9 2011

Re: K110283

Trade/Device Name: Zenius™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: April 25, 2011 Received: April 27, 2011

Dear Mr. Moore:

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. Iisting 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

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Page 2 - Mr. Patrick D. Moore

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); 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.

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/MedicalDeyices/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

A. B. Nesk
for -

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

Enclosure

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"Special 510(k): Device Modification" Number (if known):

Device Name: Medyssey Co., Ltd. Zenius™ Spinal System

Indications for Use: The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).

Prescription Use (Per 21 CFR 801.109) (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)

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

K110283 510(k) Number_

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.