K Number

Device Name

Manufacturer

MEDTRONIC SOFAMOR DANEK USA, INC.

Date Cleared

2003-06-27

(30 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

The CD HORIZON® system is intended for the following indications:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE® components are intended for the following indications: When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

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. When connecting to the VERTEX™ Reconstruction System in the cervical spine, components are intended for the following indications:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

The use of VERTEX™ multi-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

Device Description

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components, as well as implant components from other Medtronic Sofamor Danek spinal systems, which can be rigidly locked in 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 VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples 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. Please note that certain components are specifically designed to connect to 4.5mm, 5.5mm diameter rods, while other components can connect to both 5.5mm and 6.35mm rods. 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 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® Spinal System implant components are fabricated from medical grade stainless steel described by such standards as ASTM F1314 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made out of medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. Medtronic Sofamor Danek expressly warrants that these devices are fabricated from one of the foregoing material specifications. No other warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components 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 implants only. Do not use with stainless steel.

The purpose of this 510(k) submission is to add components to the existing CD HORLZON® Spinal System.

AI/ML Overview

Acceptance Criteria & Performance Study for CD HORIZON® Spinal System

Based on the provided document, the CD HORIZON® Spinal System is a medical device for spinal fixation. It received 510(k) clearance, which is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. This type of clearance does not typically involve a formal study with acceptance criteria and a detailed statistical performance analysis in the same way a PMA (Premarket Approval) would.

Therefore, the "acceptance criteria" for this device, as per a 510(k) pathway, are met by demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this is the substantial equivalence comparison itself.

Here's an breakdown based on the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for 510(k) pathway)	Reported Device Performance (as demonstrated by substantial equivalence)
Substantial Equivalence: The device must be as safe and effective as a legally marketed predicate device. This is typically assessed by comparing:	Demonstrated Substantial Equivalence: The CD HORIZON® Spinal System was found to be substantially equivalent to itself, implying that the new components or system modifications maintain the same safety and effectiveness profile as the existing, cleared CD HORIZON® Spinal System.
- Intended Use: Similar indications for use.	The indications for use are clearly defined and consistent with spinal fixation systems.
- Technological Characteristics: Similar materials, design, and operating principles.	The device consists of rods, hooks, screws, plates, staples, and other connecting components made from medical grade stainless steel or titanium/titanium alloy. These characteristics are consistent with existing spinal fixation systems. Nitinol components are specified for use with titanium implants only.
- Performance Data (if applicable and necessary): Mechanical testing, biocompatibility, etc. to ensure that any differences in technological characteristics do not raise new questions of safety or effectiveness.	While not explicitly detailed in this summary, a 510(k) submission would typically include bench testing (e.g., fatigue strength, pull-out strength) and material characterization to support the safety and mechanical integrity of the components, ensuring they perform comparably to the predicate. Biocompatibility testing would also be required for the materials used.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a "test set" or clinical study with a specific sample size in the traditional sense for evaluating device performance against acceptance criteria. The 510(k) submission relies on comparison to a predicate device ("itself" in this case), which means the "data" is primarily a technical and indications-for-use comparison rather than original clinical or performance data from a new test set.

Sample Size: Not applicable in this context as no new patient or subject data is presented for a "test set."
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This document does not involve a "test set" requiring expert consensus for ground truth. The substantial equivalence assessment is performed by the FDA reviewers based on the technical description and comparison provided by the manufacturer.

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since there is no "test set" requiring ground truth establishment by experts, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as described in this document. This typically applies to diagnostic devices where human readers interpret results with and without AI assistance. The CD HORIZON® Spinal System is a surgical implant, not a diagnostic device.

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

No, a standalone (algorithm-only) performance study was not done. The CD HORIZON® Spinal System is a mechanical implant, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

For a medical device cleared via the 510(k) pathway, the "ground truth" for demonstrating safety and effectiveness is the established safety and effectiveness of the legally marketed predicate device. In this specific case, the "ground truth" is based on the previously cleared CD HORIZON® Spinal System components and the broader class of similar spinal fixation devices.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical implant, not a machine learning model, so there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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K031655 p'/3

JUN 2 7 2003

CD HORIZON® Spinal System Summary of Safety and Effectiveness Mav 2003

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

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

Regulation Numbers: 888.3050, 888.3060 and 888.3070

Regulation Names: Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis, and Pedicle Screw Spinal System.

Codes: KWQ, KWP, MNH and MNI

III. Product Description

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The purpose of this 510(k) submission is to add components to the existing CD HORLZON® Spinal System.

IV. Indications

The CD HORIZON® system is intended for the following indications:

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORLZON® Cannulated M8 Multi-Axial Screw components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.

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COSTLESS P3/3

and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM Reconstruction System is indicated for the following:

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Lateral Connectors

Titanium ATLAS™ Cable and the CD HORIZON® Spinal System may be used with the VERTEXTM Reconstruction System.

V. Substantial Equivalence

Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to itself.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2003

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K031655

Trade/Device Name: CD Horizon Spinal System Regulatory Number: 21 CFR 888.3070 (b)(1), 888.3050, 888.3060 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MNI, MNH, KWP, KWQ Dated: May 27, 2003 Received: May 28, 2003

Dear Dr. Treharne:

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

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Page 2 - Richard W. Treharne, Ph.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 (301) 594-4639. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark N. Milliken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K031655

CD HORIZON® Spinal System Device Name:

Indications for Use:

The CD HORIZON® system is intended for the following indications:

When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass.

for

(Division Sign-Off)

Division of General, Restorative

Division of Ophthalmic
and Neurological Devices

510(k) Number

000199

(Continued on the next page)

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K031655 page 2 of 2

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-counter Use
(Optional 1-2-96)

(Division Sign-Off) Division of General, Restorative and Neurological Devices 03165 510(k) Number _

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.