The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.

Device Description

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® plates, staples and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject devices include:
• Bone screws
• Rods
• Set Screws
• Extender
• Extender Cap
• Accessories, case, caddies trays, and lids which may be used to transport and sterilize the subject implants and instruments.

The subject CD HORIZON® Spinal System device will be available in similar sizes as the predicate systems.

MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS For use with StealthStation® and IPC® POWEREASE™ Systems

Medtronic Navigated Reusable Screwdriver is a spine preparation instrument made of high grade stainless steel. This instrument was specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic single-use sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation® Image Guidance System to track the instruments in the surgical field.

Medtronic Navigated Reusable Screwdriver is compatible with various Medtronic spinal implant systems. This screwdriver is also compatible with Medtronic's IPC® POWEREASET™ System when connected to the POWEREASET™ Driver.

AI/ML Overview

This document refers to the FDA 510(k) premarket notification for the CD HORIZON® Spinal System and Medtronic Navigated Reusable Instruments.

It's important to understand that this is a 510(k) Summary, which establishes substantial equivalence to predicate devices, rather than proving novel safety and efficacy through clinical trials with specific acceptance criteria in the way a PMA (Premarket Approval) submission would. As such, the information you're looking for regarding specific acceptance criteria, study details, human reader performance, and ground truth establishment in the context of an "AI device" is not directly applicable to this type of submission for these specific medical devices.

The "device" in this context refers to spinal implants (rods, screws, etc.) and navigated surgical instruments, not an AI or algorithm-driven diagnostic or therapeutic device. The "studies" are primarily mechanical testing and biocompatibility evaluations to ensure material safety and functional equivalence to already approved devices.

Therefore, many of your requested points, particularly those related to AI algorithm performance, ground truth, expert consensus, and MRMC studies, will not be found in this document.

Here's an attempt to answer your questions based on the provided text, with clarifications where the information is not present or not relevant to this type of device submission:

1. A table of acceptance criteria and the reported device performance

For the CD HORIZON® Spinal System (implants), the acceptance criteria are generally related to the design and material characteristics being equivalent to legally marketed predicate devices, and demonstrating mechanical integrity and biocompatibility.

For the Medtronic Navigated Reusable Instruments, the acceptance criteria relate to the instruments having the same fundamental technology and material as predicate devices, and being suitable for their intended use with the StealthStation® System and IPC® POWEREASE™ System.

Acceptance Criteria (Implied from the 510(k) Summary)	Reported Device Performance/Evidence from Submission
For CD HORIZON® Spinal System:
Material Biocompatibility (as per ISO-10993)	• Bone screws, rods, set screws: Made of identical materials (Cobalt-28-Chromium-6-Molybdenum, Unalloyed Titanium, Titanium-6 Aluminum-4 Vanadium ELI) as predicate devices, conforming to relevant ASTM standards (F1537, F67, F136). Classified as permanent, >30 day body contact. • Extender, Extender Cap, Screwdriver: Made of same medical grade stainless steel as predicate devices, conforming to ASTM standards (F899, A564, A693, A276). Classified as limited, up to 24 hours body contact. • Cases/trays: Non-patient contacting, no biocompatibility testing required. • Materials (Cobalt Chrome, Titanium, Stainless Steel) have a long history of safe use, so specific testing not required for these.
Mechanical Equivalence to Predicate Devices	• Subject devices evaluated for substantial equivalence to predicate devices (K142847, K091974, K113529, K132639, K102555, K141605). • Determined that subject devices do not represent a new worst case. • Engineering rationales used to demonstrate substantial equivalence.
For Medtronic Navigated Reusable Instruments:
Fundamental Technology & Material Equivalence	• Same fundamental technology and stainless steel material as predicate devices (K140454).
Compatibility with StealthStation® and IPC® POWEREASE™ Systems	• Specifically designed for use with StealthStation® System. • Compatible with IPC® POWEREASE™ System.
Intended Function for Locating Anatomical Structures	• Intended to assist surgeons in precisely locating anatomical structures during spinal surgery. • Tracks instruments using Medtronic single-use sterile spheres and StealthStation® Image Guidance System.

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

This information is not applicable in the context of this 510(k) summary. The submission relies on mechanical testing, material specifications, and comparisons to legally marketed predicate devices, not on a human clinical "test set" with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. There was no "test set" requiring expert ground truth in the way an AI diagnostic algorithm would. The determination of "substantial equivalence" is made by the FDA based on the provided engineering, material, and performance data, and comparison to predicate devices, not by clinical experts establishing a ground truth for a dataset.

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

This information is not applicable. Since there was no clinical "test set" requiring ground truth establishment, there was no adjudication method.

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

This information is not applicable. The devices (implants and navigated instruments) are not AI-driven diagnostic or interpretative tools. No MRMC comparative effectiveness study was performed or is relevant for this type of device submission. The instruments are tools to assist the surgeon in placement, but their effectiveness is not measured by "human reader improvement with AI."

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

This information is not applicable. These devices are not standalone algorithms. The navigated instruments are tools used by a human surgeon, relying on image guidance systems.

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

This information is not applicable. The "ground truth" for this submission revolves around:

Material specifications: Conformance to ASTM standards for metals.
Mechanical performance: Engineering rationales and testing to ensure the devices perform equivalently to predicates in terms of strength, fatigue, etc. (Though specific test results are not detailed in this summary, they would be part of the full submission).
Biocompatibility: Conformance to ISO-10993 standards and historical safe use of materials.

8. The sample size for the training set

This information is not applicable. These are not AI/machine learning devices, so there is no "training set."

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

This information is not applicable. As these are not AI/machine learning devices, there is no "training set" or associated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge.

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

Medtronic Sofamor Danek USA, Incorporated Ms. Becky Ronner Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

February 13, 2015

Re: K143375

Trade/Device Name: CD HORIZON® Spinal System, Medtronic Navigated Reusable Instruments Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ, OLO, HBE Dated: January 16, 2015 Received: January 20, 2015

Dear Ms. Ronner:

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

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Page 2 - Ms. Becky Ronner

(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 (OS) 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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 yours,

Mark N. Melkerson -S

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

510(k) Number (if known)

K143375

Device Name CD HORIZON® Spinal System

Indications for Use (Describe)

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion for the following indications: degenerative disc disease (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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K143375

Device Name

Medtronic Navigated Reusable Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

MEDTRONIC Sofamor Danek USA

January 2015

	Medtronic Sofamor Danek, USA Inc.
Submitter:	1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person	Becky RonnerSenior Regulatory Affairs SpecialistDirect Telephone: (901)399-2757
Date Prepared	November 21, 2014
Common Name	Bone Screws, Rods, Set Screws, Extenders, and Drivers
Device/Trade Name	1. CD HORIZON® Spinal System
	2. MEDTRONIC NAVIGATED REUSABLEINSTRUMENTSFor use with StealthStation® and IPC® POWEREASE™Systems
Regulatory Class,Regulation Number,Regulation Name, andDevice Product Code	1. CD HORIZON® Spinal System• Class III• 21 CFR 888.3050 Spinal Interlaminal Fixation Orthosis; KWP• 21 CFR 888. 3060 Spinal Intervertebral Body Fixation Orthosis; KWQ• 21 CFR 888.3070 Pedicle Screw System; MNH, MNI, NKB, OSH
	2. MEDTRONIC NAVIGATED REUSABLE INSTRUMENTSFor use with StealthStation® and IPC® POWEREASE™ Systems• Class II• 21 CFR 882.4560 Stereoitaxic Instruments; OLO• 21 CFR 882.4310 Drills, Burs, Trephines & Accessories (Simple, Powered); HBE






Predicate Devices	1. CD HORIZON® Spinal System
	• K142847 CD HORIZON® Spinal System (S.E.
	10/27/2014) Primary Predicate
•	K091974 CD HORIZON® Spinal System (S.E 9/2/2009)
•	K113529 CD HORIZON® Spinal System (S.E 2/9/2011)
•	K132639 CD HORIZON® Spinal System (S.E11/25/2013)
•	K102555 CD HORIZON® Spinal System (S.E11/17/2010)
•	K141605 CD HORIZON® Spinal System (S.E 7/14/2014)
2.	MEDTRONIC NAVIGATED REUSABLE INSTRUMENTSFor use with StealthStation® and IPC® POWEREASE™Systems
•	K140454 Navigated Instruments (S.E 5/22/2014)
	The predicates have not been subject to a design relatedrecall.
	1. The CD HORIZON® Spinal System consists of a variety ofshapes and sizes of rods, hooks, screws, CROSSLINK®plates, staples and connecting components, as well as implantcomponents from other Medtronic spinal systems, which canbe rigidly locked into a variety of configurations, with eachconstruct being tailor-made for the individual case. Thesubject devices include:

•	Bone screws
•	Rods
•	Set Screws
•	Extender
•	Extender Cap
Description of Device	• Accessories, case, caddies trays, and lids which may beused to transport and sterilize the subject implants andinstruments.

	The subject CD HORIZON® Spinal System device will beavailable in similar sizes as the predicate systems.
	2. MEDTRONIC NAVIGATED REUSABLEINSTRUMENTS For use with StealthStation® and IPC®POWEREASE™ Systems
	Medtronic Navigated Reusable Screwdriver is a spinepreparation instrument made of high grade stainless steel.This instrument was specifically designed for use inprocedures where the use of stereotactic surgery may be
	appropriate. Placing Medtronic single-use sterile sphereson each of the NavLock™ Tracker passive stems allows aMedtronic computer-assisted surgery system such as theStealthStation® Image Guidance System to track theinstruments in the surgical field.Medtronic Navigated Reusable Screwdriver is compatiblewith various Medtronic spinal implant systems. Thisscrewdriver is also compatible with Medtronic's IPC®POWEREASET™ System when connected to thePOWEREASET™ Driver.
Indications for Use	1. CD HORIZON® Spinal SystemThe CD HORIZON® Spinal System with or withoutSEXTANT® instrumentation is intended for posterior,non-cervical fixation as an adjunct to fusion for thefollowing indications: degenerative disc disease (definedas back pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e., fracture or dislocation),spinal stenosis, curvatures (i.e., scoliosis, kyphosis, orlordosis), tumor, pseudarthrosis, and/or failed previousfusion.
	Except for hooks, when used as an anterolateralthoracic/lumbar system, the CD HORIZON® SpinalSystem may also be used for the same indications as anadjunct to fusion.With the exception of degenerative disc disease, the CDHORIZON® LEGACY™ 3.5mm rods and the CDHORIZON® Spinal System PEEK rods and associatedcomponents may be used for the aforementionedindications in skeletally mature patients as an adjunct tofusion. The 3.5mm rods may be used for the specificpediatric indications noted below.
	When used for posterior non-cervical pedicle screwfixation in pediatric patients, the CD HORIZON® SpinalSystem implants are indicated as an adjunct to fusion totreat progressive spinal deformities (i.e., scoliosis,

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		kyphosis, or lordosis) including idiopathic scoliosis,
		neuromuscular scoliosis, and congenital scoliosis.
		Additionally, the CD HORIZON® Spinal System is
		intended to treat pediatric patients diagnosed with the
		following conditions: spondylolisthesis/spondylolysis,
		fracture caused by tumor and/or trauma, pseudarthrosis,
		and/or failed previous fusion. These devices are to be used
		with autograft and/or allograft. Pediatric pedicle screw
		fixation is limited to a posterior approach.

		The CD HORIZON® SPIRE™ Plate is a posterior, single-
		level, non-pedicle supplemental fixation device intended
		for use in the non-cervical spine (T1-S1) as an adjunct to
		fusion in skeletally mature patients. It is intended for plate
		fixation/attachment to spinous processes for the purpose of
		achieving supplemental fixation in the following
		conditions: degenerative disc disease (as previously
		defined), spondylolisthesis, trauma, and/or tumor.

		In order to achieve additional levels of fixation, the CD
		HORIZON® Spinal System rods may be connected to the
		VERTEX® Reconstruction System with the VERTEX®
		rod connector. Refer to the VERTEX® Reconstruction
		System Package Insert for a list of the VERTEX®
		indications of use.

2.		MEDTRONIC NAVIGATED REUSABLE
		INSTRUMENTS For use with StealthStation® and IPC®
		POWEREASET™ Systems
		Medtronic Navigated Reusable Instruments are intended to
		be used during the preparation and placement of Medtronic
		screws during spinal surgery to assist the surgeon in
		precisely locating anatomical structures in either open, or
		minimally invasive, procedures. Medtronic Navigated
		Reusable Instruments are specifically designed for use with
		the StealthStation® System, which is indicated for any
		medical condition in which the use of stereotactic surgery
		may be appropriate, and where reference to a rigid

		anatomical structure, such as a skull, a long bone, or
		vertebra, can be identified relative to a CT or MR-based

{9}------------------------------------------------

	model, fluoroscopy images, or digitized landmarks of the
	anatomy. Medtronic Navigated Reusable Instruments are
	also compatible with the IPC® POWEREASET™ System.
	1. CD HORIZON® Spinal System
Comparison ofTechnologicalCharacteristics with thePredicate Devices:	The CD HORIZON® Spinal System has the samefundamental technology, cobalt chrome, titanium and stainlesssteel material as the predicate devices. The predicate andsubject devices are intended to help provide immobilizationand stabilization of spinal segments as an adjunct to fusion ofthe thoracic lumbar and/or sacral spine.K142847 CD HORIZON® Spinal System (S.E.10/27/2014) (Primary Predicate) K091974 CD HORIZON® Spinal System (S.E 9/2/2009) K113529 CD HORIZON® Spinal System (S.E 2/9/2011) K132639 CD HORIZON® Spinal System (S.E11/25/2013) K102555 CD HORIZON® Spinal System (S.E11/17/2010) K141605 CD HORIZON® Spinal System (S.E 7/14/2014) 2. MEDTRONIC NAVIGATED REUSABLEINSTRUMENTS For use with StealthStation® and IPC®POWEREASET™ SystemsThe subject Medtronic Navigated Reusable Instrument for usewith StealthStation® and IPC® POWEREASET™ Systemshas the same fundamental technology and stainless steelmaterial as the predicate devices. The predicate and subjectdevices are intended to be used during the preparation andplacement of Medtronic screws during spinal surgery to assistthe surgeon in precisely locating anatomical structures ineither open, or minimally invasive, procedures. MedtronicNavigated Reusable Instruments are specifically designed foruse with the StealthStation® System, which is indicated forany medical condition in which the use of stereotactic surgerymay be appropriate, and where reference to a rigid anatomicalstructure, such as a skull, a long bone, or vertebra, can beidentified relative to a CT or MR-based model, fluoroscopyimages, or digitized landmarks of the anatomy. Medtronic
	Navigated Reusable Instruments are also compatible with the

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Performance Data:	IPC® POWEREASET™ System.K140454 Navigated CD HORIZON® Instruments (S.E5/22/2014)The following performance data were provided in support ofsubstantial equivalence.
	BiocompatibilityThe biocompatibility evaluation for the CD HORIZON®Spinal System devices was conducted in accordance withFDA's Draft Guidance for Industry and FDA Staff "Use ofInternational Standard ISO-10993, Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing" issued April,23, 2013.
	The subject CD HORIZON® Spinal System bone screws,rods, and set screws are permanent implants and will beclassified as permanent , >30 day body contact according towith FDA's Draft Guidance for Industry and FDA Staff "Useof International Standard ISO-10993, Biological Evaluation ofMedical Devices Part 1: Evaluation and Testing". The subjectbone screws are manufactured from identical materials as thepredicate devices, in accordance with the following ASTMstandards:
	• ASTM F1537 – Standard Specification forWrought Cobalt-28-Chromium-6-MolybdenumAlloys for Surgical Implants
	• ASTM F67 - Specification for Unalloyed Titaniumfor Surgical Implant Applications
	• ASTM F136 - Standard Specification for WroughtTitanium-6 Aluminum-4 Vanadium ELI (ExtraLow Interstitial) Alloy for Surgical ImplantApplications
	The subject rods are manufactured from identical materials asthe predicate devices, in accordance with the followingASTM standards:
	• ASTM F1537 – Standard Specification forWrought Cobalt-28-Chromium-6-Molybdenum

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Alloys for Surgical Implants
The subject set screws are manufactured from identical materials as the predicate devices, in accordance with the following ASTM standards:
ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The CD HORIZON® Spinal System extender, Extender Cap and screwdriver are external communicating devices and are classified as limited, up to 24 hours of body contact according to with FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". These instruments are manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards:
ASTM F899 – Standard Specification for Wrought Stainless Steel for Surgical Instruments ASTM A564 – Standard Specification for Hot-Rolled and Cold Finished Age-Hardening Stainless Steel Bars and Shapes ASTM A693 – Standard Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet and Stripe ASTM A276 – Standard Specification for Stainless Bars and Shapes
The case, caddies trays, and lids used to for shipment and sterilization of instruments are manufactured from aluminum and/or radel and/or polypropylene with the brackets securing the instruments into the case/tray made of silicone and/or nylon coated stainless steel and/or polypropylene and are not patient contacting and do not require biocompatiblity testing.

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	Cobalt Chrome, Commercially Pure Titanium, TitaniumAlloy, and medical grade stainless steel have a long history ofsafe and effective use in spinal surgery and biocompatibilitytesting is not required and not testing was conducted.
	Mechanical Testing
	In accordance with, Guidance for Industry and FDA Staff –Spinal System 510(k)’s”, Medtronic has evaluated the subjectdevices to demonstrate substantial equivalence to thepredicate devices. It was determined that subject devices donot represent a new worst case. Engineering rationales wereused to demonstrate substantial equivalence.
	Based on the risk analysis, test results, and additionalsupporting documentation provided in the pre-marketnotification, the subject CD HORIZON® Spinal Systemis substantially equivalent to the following predicates:
Conclusion:	• K142847, K091974, K113529, K132639,K102555, K141605

	The MEDTRONIC NAVIGATED REUSABLEINSTRUMENTS are substantially equivalent tothe following predicate:

	• K140454

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.