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 (DDD - 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, tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD Horizon™ 3.5mm 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 titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pediative pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (1.2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

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: DDD (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 size of rods, hooks, screws, CROSSLINK(R) Plates, staples, and connecting components, and 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 purpose of this submission is to allow the use of the patient specific UNiD Rods cleared as a part of the PASS LP Spinal System with the CD Horizon™ Spinal System to allow additional surgeon options.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the CD Horizon™ Spinal System. It does not pertain to an AI/ML-driven medical device, nor does it detail a study involving expert readers or ground truth establishment for diagnostic performance. Instead, it focuses on the substantial equivalence of a physical medical device (spinal fixation system) to previously marketed predicate devices, supported by mechanical performance testing.

Therefore, the requested information regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment (as they relate to AI/ML device validation) cannot be extracted from this document.

The document primarily focuses on mechanical performance testing to ensure structural integrity and equivalence of the new version of the spinal system.

Here's what can be extracted about acceptance criteria and performance related to the mechanical testing of the device:

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

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Met pre-determined acceptance criteria as per ASTM F1717 (static and dynamic compression bending and static torsion)	Testing confirmed that the subject devices (CD Horizon™ Spinal System with PASS LP Spinal System UNiD Rods) met these criteria.
Met pre-determined acceptance criteria as per ASTM F1798 (static axial grip, static flexion extension, and dynamic flexion extension)	Testing confirmed that the subject devices (CD Horizon™ Spinal System with PASS LP Spinal System UNiD Rods) met these criteria.
Did not introduce a new worst case when used with the subject CD Horizon™ Spinal System (compared to predicates)	Confirmed through rationale and confirmatory testing.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified quantitatively in terms of number of devices or test repetitions, but "confirmatory testing" was conducted.
Data Provenance: The testing was conducted by Medtronic as part of the 510(k) submission to demonstrate substantial equivalence to legally marketed predicate devices. The country of origin for the data is implicitly the USA, where Medtronic is based and submitting to the FDA. The nature of the testing (mechanical property evaluation) means it's not "retrospective" or "prospective" in the clinical study sense; rather, it's laboratory-based engineering validation.

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 to the type of device and testing described. Mechanical performance testing relies on established engineering standards (ASTM F1717, ASTM F1798) and physical measurements, not expert human interpretation or "ground truth" derived from clinical experts in the context of diagnostic performance.

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

Not applicable. Adjudication methods are used in clinical studies or expert review processes, typically for diagnostic accuracy. Mechanical testing involves repeatable measurements and adherence to testing standards.

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:

Not applicable. This device is a physical spinal implant, not an AI/ML-driven diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for this device's performance is adherence to established mechanical performance standards (ASTM) and demonstration of equivalent or superior mechanical properties compared to predicate devices. This is based on physical property measurements rather than clinical ground truth like pathology or outcomes data for diagnostic purposes.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

Summary

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October 19, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medtronic Raphael McInnis Sr. Manager, Regulatory Affairs 1800 Pyramid Pl Memphis, Tennessee 38132

Re: K202771

Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB , KWP, KWQ Dated: September 18, 2020 Received: September 21, 2020

Dear Mr. McInnis:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part

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801 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin O'Neill Assistant Director Division of Spinal Devices Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202771

Device Name CD Horizon Spinal System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

MEDTRONIC CD Horizon™ Spinal System

September 2020

Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact Person	Raphael McInnisSenior Regulatory Affairs ManagerTelephone: (901) 396-3133
Name of Device	CD Horizon™ Spinal System
Common Name	Spinal Fixation Appliance, Spinal Fixation Orthosis
Classification Name	NKB, KWP, KWQ
Classification	Class II
Product Codes	NKB, KWP, KWQ21 CFR 888.3070 - Thoracolumbosacral Pedicle Screw System21 CFR 888.3060 - Spinal intervertebral body fixation orthosis21 CFR 888.3050 - Spinal interlaminal fixation orthosis
Predicate Devices	Primary Predicate:CD Horizon Spinal System (K113174, S.E. 11/21/2011)Secondary Predicates:PASS LP Spinal System (K140738, S.E. 11/04/2014)CD Horizon™ Spinal System (K042025, S.E. 08/25/2004)CD Horizon™ Spinal System (K201407, S.E. 09/10/2020)
Description of Devices	The predicates have not been subject to a design related recall.The CD Horizon™ Spinal System consists of a variety of shapesand size of rods, hooks, screws, CROSSLINK(R) Plates, staples,and connecting components, and well as implant components fromother Medtronic spinal systems, which can be rigidly locked into a

Indications for Use	variety of configurations, with each construct being tailor-madefor the individual case.
	The purpose of this submission is to allow the use of the patientspecific UNiD Rods cleared as a part of the PASS LP SpinalSystem with the CD Horizon™ Spinal System to allow additionalsurgeon options.
	The CD Horizon™ Spinal System with or without Sextant™instrumentation is intended for posterior, non-cervical fixation asan adjunct to fusion for the following indications: degenerativedisc disease (DDD - defined as back pain of discogenic originwith degeneration of the disc confirmed by history andradiographic studies), spondylolisthesis, trauma (i.e. fracture ordislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, orlordosis), tumor, pseudarthrosis, and/or failed previous fusion.
	Except for hooks, when used as an anterolateral thoracic/lumbarsystem, the CD Horizon™ Spinal System titanium, cobalt chrome,and stainless steel implants may also be used for the sameindications as an adjunct to fusion.
	With the exception of DDD, the CD Horizon™ Legacy™ 3.5mmrods and associated components may be used for theaforementioned indications in skeletally mature patients as anadjunct to fusion. The 3.5mm rods may be used for the specificpediatric indications noted below.
	When used for posterior non-cervical pedicle screw fixation inpediatric patients, the CD Horizon™ Spinal System titanium,cobalt chrome, and stainless steel implants are indicated as anadjunct 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 treatpediatric patients diagnosed with the following conditions:spondylolisthesis/ spondylolysis, fracture caused by tumor and/ortrauma, pseudarthrosis, and/or failed previous fusion. Thesedevices are to be used with autograft and/or allograft. Pediatricpedicle screw fixation is limited to a posterior approach.
	The CD Horizon™ PEEK rods are intended to provide posteriorsupplemental fixation when used with an interbody fusion cage forpatients diagnosed with DDD. These DDD patients may also haveup to Grade 1 spondylolisthesis or retrolisthesis at the involved
	level. This device is intended for 1-2 level use in the lumbosacralspine (L2 - S1) in skeletally mature patients. The device isintended for use with an interbody fusion cage at the instrumentedlevel and is not intended for stand-alone use.
	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 spinousprocesses for the purpose of achieving supplemental fixation inthe following conditions: DDD (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 tothe Vertex™ Reconstruction System package insert for a list ofthe Vertex™ indications of use.
	When used with the PASS LP Spinal System UNiD Rods, the CDHorizon Spinal System have the same fundamental scientific
	technology, indications for use, intended use, materials, and levelsof attachment as the predicate CD Horizon™ Spinal Systemdevices.
Comparison ofTechnologicalCharacteristics with thePredicate Devices	The difference between the primary predicate and subject devicesis that rods used with the predicate CD Horizon™ Spinal Systemare cut and bent by the surgeon based on the need of the individualcase, while the PASS LP Spinal System UNiD Rods are directlyadapted to a unique patient. However, both the subject andpredicate systems are intended to help provide immobilization andstabilization of spinal segments as an adjunct to fusion of thethoracic, lumbar, or sacral spine.
	In accordance with the Guidance for Industry and FDA Staff –Spinal System 510(k)'s, Medtronic has evaluated the subjectdevices to demonstrate substantial equivalence to the predicatedevices.
Performance Data	Rationales were provided confirming that the use of the PASS LPSpinal System UNiD Rods did not introduce a new worst casewhen used with the subject CD Horizon™ Spinal System.However, confirmatory testing in accordance with ASTM F1717(static and dynamic compression bending and static torsion) andASTM F1798 (static axial grip, static flexion extension, and
	dynamic flexion extension) was provided and met the pre-determined acceptance criteria. Therefore, Medtronic believesthat the testing confirmed that the subject devices are substantiallyequivalent to the predice devices.
Conclusion	Based on the test results and additional supporting informationprovided in this premarket notification, Medtronic believes thesubject CD Horizon™ Spinal System devices when used with thePASS LP Spinal System Patient Specific Rods are at least as safeas and effective as the legally marketed predicate devices.

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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.