The MYKRES Spinal System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological imparment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudathrosis).

The MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

Device Description

The MYKRES Spinal System is an internal fixation device for spinal surgery consisting of rods, screws, hooks and connectors available in various lengths, diameters, and configurations to enable close conformance to patient anatomy. A series of manual instruments (not a subject of this submission) intended to assist in the insertion and placement of the implants is provided in separate trays.

The rods, screws, hooks and connectors of the MYKRES Spinal System are made of Ti-6Al-4V titanium alloy conforming to ASTM F 136.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing per ASTM F 1717)	Reported Device Performance
Static compression performance	Substantially equivalent to legally marketed spinal fixation systems
Static torsion performance	Substantially equivalent to legally marketed spinal fixation systems
Dynamic axial compression bending performance	Substantially equivalent to legally marketed spinal fixation systems

2. Sample Size and Data Provenance for Test Set

Sample Size: Six (6) samples for each of the worst-case MYKRES construct for the bench testing.
Data Provenance: The data is from laboratory bench testing performed by Showa Ika Kohgyo Co., LTD. It is not patient data with country of origin.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable. The ground truth for this device is based on objective mechanical bench testing standards (ASTM F 1717), not expert consensus on medical images or clinical outcomes.

4. Adjudication Method (Test Set)

Not applicable. This was a mechanical engineering test against established ASTM standards, not a clinical trial requiring adjudication of observations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device is a spinal fixation system, and its evaluation focuses on mechanical performance and substantial equivalence to existing devices, not on human reader interpretation of images.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (spinal implant), not a software algorithm orAI.

7. Type of Ground Truth Used

The ground truth used was the established performance metrics and requirements outlined in the ASTM F 1717 standard for static compression, static torsion, and dynamic axial compression bending tests of spinal implants.

8. Sample Size for Training Set

Not applicable. This submission describes the evaluation of a physical medical device (spinal implant), not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this type of device evaluation.

Summary

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510(k) Summary

. .

Showa Ika Kohgyo Co., LTD 510(k) Premarket Notification MYKRES Spinal System

JUL - 3 2006

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Showa Ika Kohgyo Co., LTD.
Street Address:	Shiba-koen 32 Mori-building 7F, 3-4-30 Shiba-koen, Minato-ku, Tokyo 105-0011 Japan
Telephone:	81-3-5401-5340
Fax:	81-3-5401-5350
Official Correspondent:	Kazuya Oribe
E-mail Address:	oribe@showaika.co.jp
Official Contact:	Kazuya Oribe
Representative/Consultant:	Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Telephone:	(858) 792-1235
Fax:	(858) 792-1236

DEVICE NAME

Classification Name:	Orthosis, Spondylolisthesis Spinal Fixation Orthosis, Spinal Pedicle Fixation Orthosis, Spinal Interlaminar Fixation
Trade/Proprietary Name:	MYKRES Spinal System
Common Name:	Spinal Fixation System

ESTABLISHMENT REGISTRATION NUMBER

The establishment registration number for Showa Ika Kohgyo Co, LTD is 3004589749.

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510(k) Summary

DEVICE CLASSIFICATION

Pedicle screw spinal fixation systems are classified as Class II devices (21 CFR 888.3070). The product code for Orthosis, Spondylolisthesis Spinal Fixation is MNH. The product code for Orthosis, Spinal Pedicle Fixation is MNI. Nonpedicle screw fixation systems are classified as Class II devices (21 CFR 888.3050). The product code for Spinal Interlaminar Fixation Orthosis is KWP. These device classifications are reviewed by the Orthopedic Devices Branch.

INTENDED USE

The MYKRES Spinal System is 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis, with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

DEVICE DESCRIPTION

The rods, screws, hooks and connectors of the MYKRES Spinal System are made of Ti-6Al-4V titanium alloy conforming to ASTM F 136.

EQUIVALENCE TO MARKETED PRODUCT

Showa Ika Kohgyo has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the MYKRES Spinal System is substantially equivalent in intended use, materials, designs and operational principles to the following predicate devices:

J.B.S. Spine System with Pedicle Screws (K962757) from J.B.S. (USA), Inc. SYNERGY Spinal System - Closed VLS (K974749) from Interpore Cross International. MOSS Miami Spinal System (K955348, K983583, K011182) from DePuy AcroMed, Inc. OPTIMA Spinal System (K031585) from U&i Corp., America,

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	Subject Device	Predicate Devices
	MYKRES Spinal System	J.B.S. SpineSystem withPedicle Screws	SYNERGY SpinalSystem - Closed VLS	MOSS MiamiSpinal System	OPTIMASpinal System
		J.B.S. (USA),Inc.	Interpore CrossInternational	DePuy AcroMed, Inc.	U&i Corp.,America
		K962757	K974749	K955348, K983583,K011182	K031585
Intended Use	Posterior pedicle screw andnon-pedicle screw fixationindications.	Posteriorpedicle screwand non-pediclescrew fixationindications.	Posterior pediclescrew and non-pedicle screw fixationindications.	Posterior and anteriorpedicle screw andnon-pedicle screwfixation indications.	Posterior andanterior pediclescrew fixationindications.
Classification	MNH, MNI, KWP	MNH, KWP	MNH, KWP, KWQ	MNH, MNI, KWP,KWQ	MNH, KWQ,MNI
Design	Rods, polyaxial screws,monoaxial screws, hooks,connectors	Rods, polyaxialscrews,monoaxialscrews, hooks,connectors	Rods, polyaxialscrews, monoaxialscrews, hooks,connectors	Rods, polyaxialscrews, monoaxialscrews, hooks,connectors	Rods, polyaxialscrews,monoaxialscrews,connectors
Materials	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V, CP Ti,Stainless Steel	Ti-6Al-4V, StainlessSteel	Ti-6Al-4V

Comparison of Technological Characteristics

Bench Testing Data

Showa Ika Kohgyo has submitted data from testing performed in compliance with ASTM F 1717. Static compression, static torsion, and dynamic axial compression bending tests using six samples each of a worst case MYKRES construct demonstrate that the MYKRES Spinal System is substantially equivalent to legally marketed spinal fixation systems and is therefore appropriate for use in spinal fixation as described in the indications above.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three lines forming its body and wings, symbolizing health, human services, and well-being. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

Showa Ika Kogyo Company, Ltd. c/o Mr. Floyd Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130

Re: K051704

Trade/Device Name: Mykres Spinal System Regulation Number: 888.3070(b)(1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: June 15, 2006 Received: June 19. 2006

Dear Mr. Larson:

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 cnactment 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.

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Page 2 - Mr. Floyd Larson

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 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); good manufacturing practice requirements as set forth in the quality ovy; tem (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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

barbare
tos
prekup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K051704

Device Name: MYKRES Spinal System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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 General, Restorative,
and Neurological Devices

510(k) Number K051704

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.