The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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, kyphosis); tumor; pseudarthritis; 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.

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.

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

When used as a pedicle screw fixation system in skeletally mature patients, the CD HORLZON® AGILE™ Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.

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.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTF.X™ Reconstruction System through a rod connector.

Certain implant components from other Medironic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, stapies and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBERTY® rods and screws; DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature, CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® AGILE™ Dynamic Stabilization device is comprised of four components and is comprised by a combination of materials. The proximal and distal rod components arc manufactured from commercially pure titanium. The cable is fabricated from a 7x7 filament yarn made from titanium alloy, with a cylinder rotary-swaged to the end, made from the same material. The spacer portion of the device is manufactured from Polycarbonate-Urethane.

The purpose of this 510(k) submission is to include additional CD HORIZON® SEXTANT® instruments to the CD HORIZON® Spinal System.

AI/ML Overview

This document is a 510(k) summary for the CD HORIZON® Spinal System, a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance metrics of the device itself in the way an AI/software device often would.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are common for evaluations of AI or diagnostic software, is not present in this regulatory submission for a physical spinal implant system.

This 510(k) focuses on demonstrating that the updated CD HORIZON® Spinal System (specifically the inclusion of additional SEXTANT® instruments) is substantially equivalent to previously cleared predicate devices for the same indications for use.

Here's an explanation of why the requested information isn't available in this document:

No Acceptance Criteria for Device Performance: For a physical implant like a spinal system, "acceptance criteria" generally relate to manufacturing specifications, material properties, mechanical testing (e.g., fatigue, strength), biocompatibility, and sterilization, rather than diagnostic accuracy metrics. This 510(k) doesn't detail those specific engineering or biological acceptance criteria.
No "Study" in the AI/Diagnostic Sense: The determination of substantial equivalence relies on comparing the new device's design, materials, indications, and performance to a predicate device that has already been cleared. It doesn't involve a prospective clinical study to prove the device meets specific performance criteria against a clinical ground truth in the way a diagnostic algorithm would.
No Test Sets, Training Sets, or Ground Truth: These concepts relate to the evaluation of algorithms or diagnostic tools where performance is measured against a known "truth." For a spinal implant, the "performance" is its ability to provide immobilization and stabilization as an adjunct to fusion, and its safety. This is typically assessed through comparison to existing marketed devices with a known safety and efficacy profile, and potentially bench testing.
No Experts for Ground Truth/Adjudication: The regulatory review for this type of device involves evaluating the design, materials, manufacturing processes, and indications against FDA regulations and known predicate devices. It doesn't involve clinicians establishing a "ground truth" on individual cases to assess the device's diagnostic accuracy.
No MRMC or Standalone Performance: These are terms used for evaluating diagnostic performance, which is not the primary function of a spinal implant.

What the document does state regarding "performance" and "equivalence" (which is the substitute for a formal "study" in this context):

The document mentions:

"Documentation, including a risk analysis, was provided which demonstrated the subject instruments to be substantially equivalent to the predicate CD HORIZON® SEXTANT® instruments previously cleared in K051674 (SE 07/21/05) for the same indications." (Page 2, Section VI)
It also references previous 510(k) clearances for the condensed CD HORIZON® Spinal System indications (K061304) and the CD HORIZON® AGILE™ Dynamic Stabilization device indications (K060615). (Page 2, Section VI)

In summary, this 510(k) submission is for a physical medical device (spinal implant components) and therefore does not contain the types of performance data, study designs, or expert evaluations typically described for AI or diagnostic software. Its clearance is based on demonstrating substantial equivalence to predicate devices, implying similar safety and efficacy profiles.

Summary

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Page 1 of 2 K063417

CD HORIZON® Spinal System Summary of Safety and Effectiveness November 2006

JAN J 8 2007

I. Company: Medtronic Sofamor Danek, Inc. USA 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Contact: Lee Grant Supervisor, Regulatory Affairs

II. Proposed Proprietary Trade Name: CD HORIZON® Spinal System

Classification Name(s)/Product Code(s): Spinal Interlaminal Fixation and Spinal III. Intervertebral Fixation Orthosis and/or Pedicle Screw Spinal System (per 21 CFR Section 888.3050, 888.3060 and/or 888.3070) Product Codes: MNI, MNH, KWP, KWQ, NQP and NKB

IV. Product Description

The purpose of this 510(k) submission is to include additional CD HORIZON® SEXTANT® instruments to the CD HORIZON® Spinal System.

00028

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K0634117
Page 2 of 2

v. Indications

The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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, kyphosis and/or lordosis); tumor; pseudarthritis; 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.

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

When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILE™ Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.

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

VI. Substantial Equivalence

Documentation, including a risk analysis, was provided which demonstrated the subject instruments to be substantially equivalent to the predicate CD HORIZON® SEXTANT® instruments previously cleared in K051674 (SE 07/21/05) for the same indications. The condensed CD HORIZON® Spinal System indications were previously cleared in K061304 (SE 07/18/06). The CD HORLZON® AGILE™ Dynamic Stabilization device indications were cleared in K060615 (SE 10/25/06).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

JAN 1 8 2007

Re: K063417

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWQ, KWP, MNH, NQP, MNI Dated: December 18, 2006 Received: December 19, 2006

Dear Mr. Grant:

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.

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.

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); 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. Lee Grant

This letter will allow you to begin marketing your device as described in your Section 510(k) rms let 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,

Barbara buchnm

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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Page 1 of 1 November 2006

¥063417

510(k) Number (if known):

CD HORIZON® Spinal System Device Name: --------

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

T WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Barbarico Ofice
(Division Sign-Off) Concurifice of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices

AND/OR

0.009

510(k) Number K063417

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.