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, 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 DDD, 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 progressive spinal deformities (i.e. scoliosis, 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, pseudarthosis, 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 (1.2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON™M 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 subject CD HORIZON™ Spinal System consists of non-sterile domino connectors, made of Titanium Alloy, that are used to provide the surgeon with an efficient construct extension as well as connection options for multi-rod spinal constructs. The subject CD HORIZON™ Spinal System includes 1. Non-sterile Domino connectors 2. Trays and lid

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, focusing on the substantial equivalence argument for non-sterile domino connectors.

However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic performance.

The "Performance Data" section explicitly states:

"The purpose of this submission is to take the existing sterile domino connector designs, cleared in the predicate 2, and provide them non-sterile. The subject domino connectors are being created to provide additional rod connector options for surgeon convenience. No design changes have been made to the subject devices as a result of this submission. The subject devices remain identical to the designs cleared in the predicate 2 with the same intended use, materials, and fundamental technology. As a result, the subject CD HORIZON™ Spinal System does not represent a new worst case; therefore, no new bench performance testing is warranted."

And regarding biocompatibility, it states:

"Identical to the predicate devices, the subject domino connectors are made of Titanium Alloy. This material is considered biocompatible due to its long history of clinical use in medical devices."

Based on this information, the device discussed (CD HORIZON™ Spinal System domino connectors provided non-sterile) is a physical medical device (spinal fixation system component) and not an AI/ML-driven device or a diagnostic tool that would typically have acceptance criteria presented as sensitivity, specificity, or similar performance metrics derived from a study involving ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving performance, as this type of information is not present in the provided text for this particular device submission. The submission relies on demonstrating substantial equivalence to previously cleared predicate devices due to no change in design or fundamental technology, other than the sterilization status of the component.

Summary

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January 15, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.

Medtronic Sofamor Danek USA, INC. Madhuvanthi Soundirarajan Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K203678

Trade/Device Name: CD HORIZON™ Spinal System Regulation Number: 21 CFR 8888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NQP, NKB, KWP, KWQ Dated: December 17, 2020 Received: December 17, 2020

Dear Madhuvanthi Soundirarajan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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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Indications for Use

510(k) Number (if known)

K203678

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 may also be used for the same indications as an adjunct to fusion.

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.

FORM FDA 3881 (7/17)

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K203678

510(k) Summary

MEDTRONIC CD HORIZON™ Spinal System

November 2020

I. Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person	Madhuvanthi SoundirarajanRegulatory Affairs SpecialistEmail: madhuvanthi.soundirarajan(@medtronic.comTelephone: (352)-433-9130
Date Prepared	December 2020
II. Name of Device	CD HORIZON™ Spinal System
Common Name	Thoracolumbosacral Pedicle Screw System, Spinal FixationOrthosis, Spinal Fixation Appliance
Classification Name	Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070)Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050) SpinalIntervertebral Body Fixation Orthosis (21 CFR 888.3060)
Classification	Implants: Class II
Product Codes	NQP (888.3070); NKB (888.3070)
Subsequent Codes	KWP (888.3050), KWQ (888.3060)
III. Predicate Devices	Predicate 1 (Primary Predicate)- CD HORIZON™ SpinalSystem- K182928 (S.E. 01/11/2019)Predicate 2: CD HORIZON™ Spinal System - K182119 (S.E.08/29/2018)Predicate 3: CD HORIZON™ Spinal System - K140449 (S.E.03/25/2014)
IV. Description	The subject CD HORIZON™ Spinal System consists of non-sterile domino connectors, made of Titanium Alloy, that are usedto provide the surgeon with an efficient construct extension as
V. Indications for Use	well as connection options for multi-rod spinal constructs. Thesubject CD HORIZON™ Spinal System includes1. Non-sterile Domino connectors2. Trays and lidThe CD Horizon™ Spinal System with or without Sextant™instrumentation is intended for posterior, non-cervical fixation asan adjunct to fusion for the following indications: degenerative discdisease (DDD - defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies), 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/lumbarsystem, the CD Horizon™ Spinal System titanium, cobalt chrome,and stainless steel implants may also be used for the sameindications as an adjunct to fusion.With the exception of DDD, the CD Horizon™ Legacy™ 3.5mmrods and associated components may be used for theaforementioned indications in skeletally mature patients as anadjunct to fusion. The 3.5mm rods may be used for the specificpediatric indications noted below.When used for posterior non-cervical pedicle screw fixation inpediatric patients, the CD Horizon™ Spinal System titanium,cobalt chrome, and stainless steel implants are indicated as anadjunct to fusion to treat progressive spinal deformities (i.e.scoliosis, kyphosis, or lordosis) including idiopathic scoliosis,neuromuscular scoliosis, and congenital scoliosis. Additionally, theCD Horizon™ Spinal System is intended to treat pediatric patientsdiagnosed with the following conditions:spondylolisthesis/spondylolysis, fracture caused by tumor and/ortrauma, pseudarthrosis, and/or failed previous fusion. Thesedevices are to be used with autograft and/or allograft. Pediatricpedicle screw fixation is limited to a posterior approach.The CD Horizon™ PEEK rods are intended to provide posteriorsupplemental fixation when used with an interbody fusion cage forpatients diagnosed with DDD. These DDD patients may also 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. The device is intended
	for use with an interbody fusion cage at the instrumented level and
	is not intended for stand-alone use.

	The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally maturepatients. It is intended for plate fixation/attachment to spinousprocesses for the purpose of achieving supplemental fixation in thefollowing conditions: DDD (as previously defined),spondylolisthesis, trauma, and/or tumor.
	In order to achieve additional levels of fixation, the CD Horizon™
	Spinal System rods may be connected to the Vertex™
	Reconstruction System with the Vertex™ rod connector. Refer to
	the Vertex™ Reconstruction System package insert for a list of the
	Vertex™ indications of use.
	The subject CD Horizon™ Spinal System and the primary predicate
	have identical intended use, indications, levels of attachment, and
	fundamental scientific technology. The subject devices have the
	same intended use, material, and fundamental technology as the
	predicate 2 domino connectors. The subject domino connectors and
	the predicate 2 domino connectors have identical rod compatibility,
	material, length, height, width, and thread form for set screw use.
	The only difference between the subject domino connectors and the
VI. Comparison of	predicate 2 is that the subject domino connectors will be provided
Technological	non-sterile, which is identical to predicate 3 domino connectors.
Characteristics with	Like the predicate 3 domino connectors, the subject domino
the Predicate Devices	connectors will be provided non-sterile, intended to be steam
	sterilized by the end user.
	By providing the subject domino connectors non-sterile, the safety
	and effectiveness of the device is not affected since the predicate 3
	CD Horizon™ Spinal System has similar domino connectors with
	identical sterilization method.


	Please see the Substantial Equivalence section of this submission
VII. Performance Data	Mechanical TestingThe purpose of this submission is to take the existing steriledomino connector designs, cleared in the predicate 2, and providethem non-sterile. The subject domino connectors are being createdto provide additional rod connector options for surgeonconvenience. No design changes have been made to the subjectdevices as a result of this submission. The subject devices remainidentical to the designs cleared in the predicate 2 with the sameintended use, materials, and fundamental technology. As a result,the subject CD HORIZON™ Spinal System does not represent anew worst case; therefore, no new bench performance testing iswarranted. Please see the Bench Performance Testing section ofthis submission for more detail.BiocompatibilityIdentical to the predicate devices, the subject domino connectorsare made of Titanium Alloy. This material is consideredbiocompatible due to its long history of clinical use in medicaldevices. Please see the Biocompatibility section of thissubmission for more detail.
VIII. Conclusion	Based on the supporting evidence provided, Medtronic believes thesubject devices are substantially equivalent to the below predicates.Predicate 1 (Primary Predicate): CD HORIZON™Spinal System – K182928 (S.E. 01/11/2019) Predicate 2: CD HORIZON™ Spinal System – K182119(S.E. 08/29/2018) Predicate 3: CD HORIZON™ Spinal System – K140449(S.E. 03/25/2014)

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K203678

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K203678

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.