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 and/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® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. 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.

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.

A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates, and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain components within the CD HORIZON® Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, SPIRE™ Plates and DYNALOK® bolts. All screws used in pediatric cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy.

Certain implant components from other Medtronic spinal systems can be used with the CD HORIZON® Spinal System in non-pediatric cases. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples, washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws; DYNALOK® PLUS and DYNALOK CLASSIC® bolts along with rod/bolt connectors; and Medtronic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

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

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, medical grade cobaltchromium-molybdenum alloy, or medical grade PEEK OPTIMA-LT1. Certain CD HORIZON® Spinal System components may be coated with hydroxyapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MDT Catalog for further information about warranties and limitations of liability.

Never use stainless steel and titanium implant components in the same construct.

Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients.

PEEK OPTIMA-LTI implants may be used with stainless steel, titanium, or cobaltchromium-molybdenum alloy implants. CD HORIZON® PEEK Rods are not to be used with CROSSLINK® Plates or in pediatric patients.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

The purpose of this SI0(k) was to add SOLERA™ reduction multi-axial screws manufactured out of cobalt chrome, titanium alloy and commercially pure titanium and associated reduction setscrews manufactured out of medical grade titanium alloy to the CD HORIZON® Spinal System for use with 4.75mm diameter rods.

AI/ML Overview

The provided text is a 510(k) Summary for the CD HORIZON® Spinal System (K112473). This document is a premarket notification to the FDA for medical devices and focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials for effectiveness or measuring device performance against specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details demonstrating performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

Here's a breakdown of why the requested information isn't present in this type of document:

Acceptance Criteria & Reported Performance: The 510(k) pathway is primarily for demonstrating equivalence. It doesn't typically require setting new, quantitative performance acceptance criteria or conducting studies to measure device performance against them in the same way a PMA (Premarket Approval) would. The "performance" discussed here relates to the equivalence to predicate devices, not novel performance metrics.
Sample Sizes (Test/Training Sets) & Data Provenance: Since no new clinical or standalone performance studies are conducted with explicit test/training sets as one would for an AI/algorithm-based device, these details are absent.
Number of Experts & Qualifications for Ground Truth: This is relevant for studies establishing ground truth for diagnostic or AI algorithm performance. It's not applicable to a 510(k) for a spinal implant where the "ground truth" is typically established by well-understood biomechanical principles and established clinical practice.
Adjudication Method: Similar to the above, this is for assessing performance of a diagnostic or AI tool, not for a hardware implant.
MRMC Comparative Effectiveness Study: This type of study is specifically for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k).
Standalone Performance Study: This would be for an algorithm's performance without human intervention. This 510(k) is for a spinal implant, which is a physical device used in surgery, not a standalone algorithm.
Type of Ground Truth Used: For a spinal implant, the ground truth for "effectiveness" is clinical outcomes after implantation, which would be gathered in post-market surveillance or specific clinical trials (not usually part of a 510(k)). The immediate "truth" related to the device's design is its physical characteristics and biomechanical properties, which are compared to predicates.
Sample Size for Training Set & Ground Truth for Training Set: These are concepts for machine learning model development, not for a physical medical device submission like this one.

What the document does describe related to "testing":

The document mentions "Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices." It also explicitly states, "Non-clinical testing in the form of mechanical testing was not required for the subject devices since the only difference between them and the predicate devices were the addition of extended tabs on the screw heads and extended threads on the break-off portion of the setscrew."

This indicates that the "study" for this 510(k) was primarily a comparison of design features, materials, and indications for use to predicate devices, and internal design verification/validation activities to ensure the new components met their intended specifications and were equivalent to the existing predicate device components. This is a common approach for modifications to existing devices under the 510(k) pathway.

Summary

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CD HORIZON® Spinal System 510(k) Summary - K112473 September 28, 2011

I. Company: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Contact: Chris McKec Sr. Regulatory Affairs Specialist

Proprietary Trade Name: CD HORIZON® Spinal System II.

III. Classification Name: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle Screw Spinal System (21 CFR 888.3050, 888.3060 and 888.3070)

IV. Classification: Class III (Pre-amendment)

V. Product Codes: KWP, KWQ, MNH, MNI, NKB and OSH

VI. Product Description

Page 1 of 4

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K. 112473

components are specifically designed to connect to specific rod diameters, while other components can connect to multiple rod diameters. Care should be taken so that the correct components are used in the spinal construct.

Never use stainless steel and titanium implant components in the same construct.

VII. Indications

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K // 247̇3

spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/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.

VIII.

Summary of the Technological Characteristics

The subject reduction screws and setscrews provide an additional fixation option for connecting to 04.75mm rods. The primary difference is that the subject screws have extended tabs on the head, and the subject setscrews have an extended thread on the break-off portion. These features aid in rod capture and reduction. The materials, thread forms, and sizes are the same as the predicate devices.

IX.

Identification of Legally Marketed Devices

The design features, materials and indications for use of the subject screws are substantially equivalent to predicate CD HORIZON® Spinal System devices for use with 5.5mm diameter rods (K042025 SE 08/25/04) and 4.75mm diameter rods (K091974 SE 09/02/09).

The design features, materials and indications for use of the subject setscrews are substantially equivalent to predicate CD HORIZON® Spinal System setscrews for use with 5.5mm diameter rods (K052187 SE 08/22/05) and 4.75mm diameter rods (K102555 SE 11/17/10).

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K//2473

The labeling is identical to that cleared in KII1457 (SE 09/15/11) except for changes made for the purposes of clarification.

X. Discussion of the Non-Clinical Testing

Non-clinical testing in the form of mechanical testing was not required for the subject devices since the only difference between them and the predicate devices were the addition of extended tabs on the screw heads and extended threads on the break-off portion of the setscrew. Both of these features are removed after implantation.

Non-clinical testing in the form of design verification and validation activities was performed on the subject devices to show equivalence to the previously listed predicate devices.

XI. Conclusions

A risk analysis was completed for the changes incorporated into the subject devices. Based on the results and additional supporting documentation provided in this premarket notification, the subject devices demonstrated substantial equivalence to the previously listed predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

June 27, 2013

Medtronic Sofamor Danek USA, Inc. % Mr. Chris McKee Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K112473

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP, KWQ Dated: August 25, 2011 Received: September 27, 2011

Dear Mr. McKee:

This letter corrects our substantially equivalent letter of October 21, 2011.

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Chris McKee

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 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 yours,

Image /page/5/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and some of them have decorative elements. The name appears to be a logo or signature.

For

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

Enclosure

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K//2473

510(k) Number (if known): K | 12473

Device Name: CD HORIZON® Spinal System

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 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 skelctally 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® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondy|olisthesis/spondy|olysis, and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allografi. 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 (TI-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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (2) CFR Subparı 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 Surgical, Orthopedic, and Restorative Devices

Page I of I

510(k) Number K112473 Page 1 of /

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.