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, kyphosis, 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 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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric 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 (L2 - S1) in skeletally mature patients. Devices are 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, spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, 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 Vertex™ indications.

The IPCTM System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures. The IPC™ Powerease™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts, and rods. Do not implant instruments.

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPCTM Powerease™ System. Do not implant the instruments.

Medtronic Navigated Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments. Do not implant the instruments.

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 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar 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. Screws used in pediatric cases are only cleared for use via a posterior approach. 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, and 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. Note: 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 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. CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromium-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. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum 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-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use 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 orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

The Medtronic Reusable Instruments compatible with Medtronic's IPCTM Powerease™ System are spine preparation instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. Instruments may be connected to the Powerease™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic singleuse sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. These instruments are also compatible with Medtronic's IPCTM Powerease™ System when connected to the Powerease™ Driver.

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic singleuse sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. If the device passes the visual and functional inspection as described in the IFU, the instrument can be expected to perform as intended for the perioperative period.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic CD Horizon™ Spinal System. It describes the device, its indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not describe an AI/ML-based device or a study with acceptance criteria and performance metrics typically associated with such devices (e.g., sensitivity, specificity, AUC).

Instead, the "Performance Data" section (VII on page 13) focuses on mechanical testing of the spinal implant system and associated instruments to demonstrate substantial equivalence to predicate devices. The acceptance criteria mentioned are related to these mechanical tests, not to AI/ML performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device because the document describes a mechanical spinal implant system.

Here's what can be extracted regarding the device performance and testing, which is not AI/ML-related:

1. Table of acceptance criteria and reported device performance:

Test Name	Acceptance Criteria (Internal, based on predicate equivalence)	Reported Device Performance
Static Compression	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Static Torsion	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Compression Fatigue	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Axial Grip (ASTM F1798)	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Axial Torsion (ASTM F1798)	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Flexion Extension Static	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Flexion Extension Fatigue	Not explicitly stated, but implies performance comparable to predicate devices.	"the pre-determined acceptance criteria have been met for all tests."
Decapitation testing	Not explicitly stated, but implies performance comparable to predicate devices. (This likely refers to a test method for spinal constructs rather than actual decapitation).	"the pre-determined acceptance criteria have been met for all tests."

Missing Information (as the device is not AI/ML):

Sample size for the test set and data provenance: Not applicable for mechanical testing.
Number of experts used to establish ground truth & qualifications: Not applicable for mechanical testing.
Adjudication method: Not applicable for mechanical testing.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for mechanical testing.
Standalone (algorithm only) performance: Not applicable for mechanical testing.
Type of ground truth used: Not applicable for mechanical testing (ground truth is physical measurement against standards).
Sample size for the training set: Not applicable (no AI/ML training).
How ground truth for the training set was established: Not applicable (no AI/ML training).

In summary, the provided document is a regulatory submission for a traditional medical device (spinal implant system) and its associated instruments, not an AI/ML device. Therefore, the requested AI/ML-specific performance metrics and study details are not present.

Summary

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May 25, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

Medtronic Sofamor Danek, USA Inc. Justin O'Connor Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K221244

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, HBE, OLO Dated: April 29, 2022 Received: May 2, 2022

Dear Mr. O'Connor:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K221244

Device Name CD Horizon™ Spinal System

Indications for Use (Describe)

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, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatic indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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, or lordosis) including idiopathic 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 tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatic 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 I spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for standalone 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, spondvlolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, 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 Vertex™ indications.

Type of Use (Select one or both, as applicable)

X 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known)

K221244

Device Name

Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems

Indications for Use (Describe)

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC™ Powerease™ System.

Do not implant the instruments.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known)

K221244

Device Name

Medtronic Reusable Instruments for use with the IPC™ Powerease™ System

Indications for Use (Describe)

The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC™ Powerease™ System is indicated for drilling, tapping, and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts, and rods.

Do not implant instruments.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known)

K221244

Device Name

Medtronic Navigated Manual Reusable Instruments for use with StealthStation™ System

Indications for Use (Describe)

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medronic implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments can be compatible with various Medtronic spinal implant systems. Navigated surgical instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. An instrument may incorporate a measuring function, which has uses as described on the label and the instruments.

Do not implant the instruments.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

MEDTRONIC CD HORIZON™ Spinal System

April 29, 2022

I. Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133
Contact Person	Justin O'ConnorSr. Regulatory Affairs SpecialistTelephone Number: (901)396-3133Email: justin.oconnor@medtronic.com
Date Prepared	April 29, 2022
II. Name of Device	CD Horizon™ Spinal System
Common Name	Bone Screw, Pedicle Screw, Powered Instrument, Stereotaxic Instrument
Classification Name	Thoracolumbosacral Pedicle Screw System, Drills, Burrs, Trephines & Accessories (Simple, Powered), Orthopedic Stereotaxic Instrument
Classification	Implants: Class IIInstruments/Accessories: Class II
Product Codes	NKB, KWP, KWQ (888.3070, 888.3060, 888.3050), HBE (882.4310), OLO (882.4560)
III. Predicate Devices	Primary Predicate:CD Horizon™ Spinal System (K210637, S.E. 04/30/2021)
	Additional Predicates:CD Horizon™ Spinal System (K201407, S.E. 09/10/2020)CD Horizon™ Spinal System (K042025, S.E. 08/25/2004)CD Horizon™ Spinal System (K113174, S.E. 11/21/2011)CD Horizon™ Spinal System (K141604, S.E. 10/21/2014)CD Horizon™ Spinal System (K091974, S.E. 09/02/2009)CD Horizon™ Spinal System (K132471, S.E. 10/08/2013)CD Horizon™ Spinal System (K150178, S.E. 02/11/2015)CD Horizon™ Spinal System (K140454, S.E. 05/22/2014)CD Horizon™ Spinal System (K153442, S.E. 02/18/2016)
	The predicates have not been subject to a design related recall.
	CD Horizon™ Spinal System
IV. Description	The CD Horizon™ Spinal System consists of a variety of shapesand sizes of rods, hooks, screws, Crosslink™ Plates, staples, andconnecting components, as well as implant components from otherMedtronic spinal systems which can be rigidly locked into a varietyof configurations, with each construct being tailor-made for theindividual case. A subset of CD Horizon™ Spinal Systemcomponents may be used for posterior pedicle screw fixation inpediatric cases. These constructs may be comprised of a variety ofshapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm),hooks, screws, Crosslink™ plates and connecting components.Similar to the CD Horizon™ implants used in adult cases, thesecomponents 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 arespecifically excluded for use in pediatric patients. These includePEEK rods, Shape Memory Alloy Staples, Spire™ plates, andDynalok™ bolts. Screws used in pediatric cases are only cleared foruse via a posterior approach. Components used in pediatric casesare fabricated from medical grade stainless steel, medical gradetitanium, titanium alloy, and medical grade cobalt-chromium-molybdenum alloy. Certain implant components from otherMedtronic spinal systems can be used with the CD Horizon™Spinal System in non- pediatric cases. These components includeTSRH™ 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 and Dynalok Classic™ bolts along with rod/boltconnectors; and Medtronic multi-axial rods and screws. Note:certain components are specifically designed to connect to specificrod diameters, while other components can connect to multiple roddiameters. Care should be taken so the correct components are usedin the spinal construct. CD Horizon™ hooks are intended forposterior use only. CD Horizon™ staples and CD Horizon™Eclipse™ rods and associated screws are intended for anterior useonly. However, for patients of smaller stature and pediatric patients,CD Horizon™ 4.5mm rods and associated components may be usedposteriorly. CD Horizon™ Spinal System implant components are

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fabricated from medical grade stainless steel, medical grade titanium alloy, medical grade cobalt-chromiumtitanium. 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. Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobalt-chromiummolybdenum 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-chromiummolybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK Optima-LT1 implants may be used with titanium or cobalt-chromium-molybdenum alloy implants. CD Horizon™ PEEK rods are not to be used in pediatric patients. PEEK rods are only to be used with the associated pedicle screws as well as interbody fusion devices in the anterior spinal column. To achieve best results, do not use 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 orthopedic and neurosurgical implants, none of the CD Horizon™ Spinal System components should ever be reused under any circumstances.

Medtronic Reusable Instruments for use with IPCTM Powerease™ System

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Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems

Medtronic Navigated Manual Reusable Instruments for use with the StealthStation™ System

Medtronic Navigated Reusable Instruments are spine preparation instruments made of high-grade stainless steel. These instruments are specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. Placing Medtronic singleuse sterile spheres on each of the NavLock™ Tracker passive stems allows a Medtronic computer-assisted surgery system such as the StealthStation™ Image Guidance System to track the instruments in the surgical field. Medtronic Navigated Reusable Instruments are compatible with various Medtronic spinal implant systems. If the device passes the visual and functional inspection as described in the IFU, the instrument can be expected to perform as intended for the perioperative period.

CD Horizon™ Spinal System

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as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients, 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, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric 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 (L2 - S1) in skeletally mature patients. Devices are 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, spondylolisthesis, trauma, and/or tumor. To achieve additional levels of fixation, 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 Vertex™ indications.

Medtronic Reusable Instruments for use with IPCTM Powerease™ System

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The IPC™ Powerease™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts, and rods. Do not implant instruments.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ Powerease™ Systems

Medtronic Navigated Manual Reusable Instruments for use with the StealthStation™ System

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VI. Comparison ofTechnologicalCharacteristics withthe Predicate Devices	The subject devices have the same intended use, indications for use,materials, similar overall design, fundamental technology,sterilization, and surgical technique as the following CD Horizon™Spinal System predicates:K210637 (S.E. 04/30/2021), K201407 (S.E. 09/10/2020),K042025 (S.E. 08/25/2004), K113174 (S.E. 11/21/2011),K141604 (S.E. 10/21/2014), K091974 (S.E. 09/02/2009),K132471 (S.E. 10/08/2013), K150178 (S.E. 02/11/2015),K140454 (S.E. 05/22/2014), and K153442 (S.E. 02/18/2016).The subject and predicate implants and instruments have thesame function and fundamental scientific technology.
VII. Performance Data	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.The subject devices have been tested or rationalized based on ifMedtronic believes that testing is not warranted for the subjectdevices as they do not present a new worst case when compared tothe predicates.The mechanical tests that were performed per ASTM F1717 includeStatic Compression, Static Torsion, Compression Fatigue, and perASTM F1798 include Axial Grip, Axial Torsion, Flexion ExtensionStatic, Flexion Extension Fatigue. In addition to the ASTM testing,Medtronic also performed Decapitation testing. For the testedsubject devices, the pre-determined acceptance criteria have beenmet for all tests.For subject devices that are rationalized, all existing predicate datapreviously provided in the predicate 510(k)s is still applicable.Therefore, Medtronic believes design verification testingdemonstrated that the subject devices are substantially equivalentto the predicate devices. Design validation testing has also beenperformed and demonstrated that the subject devices performed asintended.
VIII. Conclusion	Based on the supporting evidence provided in this premarketnotification, Medtronic believes the subject devices aresubstantially equivalent to the predicate devices.

VI. Comparison ofTechnologicalCharacteristics withthe Predicate Devices

The subject devices have the same intended use, indications for use,materials, similar overall design, fundamental technology,sterilization, and surgical technique as the following CD Horizon™Spinal System predicates:K210637 (S.E. 04/30/2021), K201407 (S.E. 09/10/2020),K042025 (S.E. 08/25/2004), K113174 (S.E. 11/21/2011),K141604 (S.E. 10/21/2014), K091974 (S.E. 09/02/2009),K132471 (S.E. 10/08/2013), K150178 (S.E. 02/11/2015),K140454 (S.E. 05/22/2014), and K153442 (S.E. 02/18/2016).The subject and predicate implants and instruments have thesame function and fundamental scientific technology.

VII. Performance Data

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.The subject devices have been tested or rationalized based on ifMedtronic believes that testing is not warranted for the subjectdevices as they do not present a new worst case when compared tothe predicates.The mechanical tests that were performed per ASTM F1717 includeStatic Compression, Static Torsion, Compression Fatigue, and perASTM F1798 include Axial Grip, Axial Torsion, Flexion ExtensionStatic, Flexion Extension Fatigue. In addition to the ASTM testing,Medtronic also performed Decapitation testing. For the testedsubject devices, the pre-determined acceptance criteria have beenmet for all tests.For subject devices that are rationalized, all existing predicate datapreviously provided in the predicate 510(k)s is still applicable.Therefore, Medtronic believes design verification testingdemonstrated that the subject devices are substantially equivalentto the predicate devices. Design validation testing has also beenperformed and demonstrated that the subject devices performed asintended.

VIII. Conclusion

Based on the supporting evidence provided in this premarketnotification, Medtronic believes the subject devices aresubstantially equivalent to the predicate devices.

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.