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 (T)-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.

The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.

The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 4.75mm lined rods in cobaltchromium-molybdenum alloy.

AI/ML Overview

Here's an analysis of the provided text regarding the CD HORIZON® Spinal System's acceptance criteria and studies:

Analysis of the Provided Text

The provided text (a 510(k) summary) describes an addition of "lined rods" to an existing spinal system. It does not describe a study involving an algorithm, AI, or human readers. Instead, it describes a submission for a traditional medical device (spinal implant components), where the acceptance criteria and supporting "study" are focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing.

Therefore, many of the requested categories (like AI performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone AI performance, etc.) are not applicable to this type of device submission and are not present in the document.

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence")

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as per non-clinical tests)
No new risks introduced by the modified device (the additional lined rods).	"Verification and validation activities demonstrated that no new risks have been introduced to CD HORIZON® Spinal System by the addition of the subject lined rods."
The modified device does not create a new worst-case scenario for the overall CD HORIZON® Spinal System.	"Verification and validation activities demonstrated... that the addition of the subject lined rods does not create a new worst case for the overall CD HORIZON® Spinal System."
The modified device maintains the same fundamental scientific technology as the predicate device.	"The subject CD HORIZON® Spinal System, including the additional lined rods, has the same fundamental scientific technology as the predicate CD HORIZON® Spinal System."
The modified device (lined rods) has the same critical dimensions (e.g., diameter, length) as relevant predicate rods.	"Like the predicate CD HORIZON® Spinal System rods, the subject rods are 4.75mm in diameter and are 500mm in length."
The modified device is manufactured from the same material specification as the predicate rods.	"The subject rods are manufactured from the same cobalt chromium alloy per ASTM F1537 as the predicate rods."
The labeling and indications for use remain substantially equivalent to predicate devices, or changes are justified.	The Indications for Use section outlines the usage for the updated system and is presented in the context of being substantially equivalent to previously cleared devices. The addition of the "lined" feature is noted as a visual aid to the surgeon, not a change in fundamental function or indication.
Previously submitted testing for relevant components (e.g., CD HORIZON® LEGACY™ 4.5 devices) remains applicable to the modified device.	"The previously submitted testing for CD HORIZON® LEGACY™ 4.5 devices still applies." (This implies that the new component does not invalidate prior testing, supporting the "no new worst-case" and "no new risk" criteria).
A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures.	"A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures." (This is a procedural acceptance criterion, indicating compliance with design control processes).
Overall conclusion: The modified device is substantially equivalent to legally marketed predicate devices.	"Therefore, Medtronic believes the subject CD HORIZON® Spinal System, including the subject lined rods, to be substantially equivalent to legally marketed predicate devices, including the predicate CD HORIZON® Spinal System." (FDA's letter confirms agreement with this determination.)

Detailed Responses to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. It is crucial to understand that for a 510(k) submission for a modification to a traditional medical device, "acceptance criteria" are not typically quantitative performance metrics like sensitivity/specificity. Instead, they are around proving "substantial equivalence" to a predicate device, which involves demonstrating that the new device is as safe and effective as the predicate without introducing new questions of safety or effectiveness. This is primarily done through non-clinical (bench) testing, material comparisons, and analysis of design changes.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This submission focuses on non-clinical (bench) testing of physical components. There is no "test set" of patient data in the context of an algorithm or diagnostic device. The evaluation is based on material properties, dimensional comparisons, and mechanical testing of the rods themselves. No patient data (country of origin, retrospective/prospective) is involved.
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):
- N/A. Ground truth, in the context of expert consensus, is not relevant for this type of device. The "truth" for this device modification is established through engineering and material science principles, comparing the new component to existing, cleared components.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically associated with human reviewer disagreements in diagnostic or AI studies. This is a submission for physical device components based on non-clinical testing.
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:
- N/A. This is a physical spinal implant, not an AI or diagnostic tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device has no algorithm. It is a physical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the device itself: The "ground truth" or standard for safety and effectiveness is established by the performance and safety profile of the legally marketed predicate devices (CD HORIZON® Spinal System K131321, K091974, K042025). The non-clinical tests demonstrate that the modified device performs equivalently to these predicates in terms of mechanical properties and material composition. There is no "ground truth" in the diagnostic sense (e.g., pathology report).
The sample size for the training set:
- N/A. This is not an AI or machine learning device and therefore has no training set.
How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.

In summary: The provided document is a 510(k) summary for a minor modification (adding lined rods) to an existing spinal implant system. The "study" involves non-clinical (bench) testing and analysis to demonstrate that the new component is substantially equivalent to previously cleared components, without introducing new safety or effectiveness concerns. It does not pertain to AI, algorithms, or studies involving patient data or human readers in the way these questions are posed.

Summary

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CD HORIZON® Spinal System 510(k) Summary July 8, 2013

I. Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133	AUG 0 6 2013
II. Contact:	Lauren KamerSenior Regulatory Affairs Specialist
III. Proprietary Trade Name:	CD HORIZON® Spinal System
IV. Common Name:	Spinal Fixation Appliance, Spinal Fixation Orthosis
V. 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)
Classification:	Class III (Pre-amendment)

VI. Product Description

Product Codes:

NKB, KWP, KWQ, MNH, MNI, and OSH

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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.

The system also includes various instruments used to assist in the implantation of the system via minimally invasive approaches.

The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional lined rods to the system, specifically, 4.75mm lined rods in cobaltchromium-molybdenum alloy.

VII. Indications for Use

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, 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.

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.

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The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) 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.

VIII. Summary of Technological Characteristics

The subject CD HORIZON® Spinal System, including the additional lined rods, has the same fundamental scientific technology as the predicate CD HORIZON® Spinal System. Like the predicate CD HORIZON® Spinal System rods, the subject rods are 4.75mm in diameter and are 500mm in length. The subject rods are manufactured from the same cobalt chromium alloy per ASTM F1537 as the predicate rods. The subject rods are lined to provide a visual aid to the surgeon when contouring the rod in a certain plane

IX. Identification of the Legally Marketed Predicate Devices Used to Claim Substantial Equivalence

The design features, materials, labeling, and indications for use of the subject devices are substantially equivalent to devices previously cleared as part of CD HORIZON® Spinal System (K131321, SE Jun 5, 2013; K091974, SE Sept 2, 2009; K042025, SE Aug 25, 2004).

X. Brief Discussion of the Non-Clinical Tests Submitted

A risk analysis of the device modifications was completed in accordance with Medtronic design control procedures. Verification and validation activities demonstrated that no new risks have been introduced to CD HORIZON® Spinal System by the addition of the subject lined rods, and that the addition of the subject lined rods does not create a new worst case for the overall CD HORIZON® Spinal System. The previously submitted testing for CD HORIZON® LEGACY™ 4.5 devices still applies.

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XI. Conclusions Drawn from the Non-Clinical Tests

Verification and validation activities demonstrated that no new risks have been introduced to CD HORIZON® Spinal System by the addition of the subject lined rods, and that the addition of the subject lined rods does not create a new worst case for the overall CD HORIZON® Spinal System. Therefore, Medtronic believes the subject CD HORIZON® Spinal System, including the subject lined rods, to be substantially equivalent to legally marketed predicate devices, including the predicate CD HORIZON® Spinal System.

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Public Health Service

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

August 6. 2013

Medtronic Sofamor Danek USA, Incorporated % Ms. Lauren E. Kamer Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K132111

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: July 08. 2013 Received: July 09. 2013

Dear Ms. Kamer:

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 10 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 (21 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

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Page 2 - Ms. Lauren E. Kamer

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 requlation (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/Reportal/roblem/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/Resources/orYou/Industry/default.htm.

Sincerely yours.

Erin I. Keith

l'or

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

Enclosure

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510(k) Number (if known): K132111

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE --- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132111

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.