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.

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 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.

AI/ML Overview

This document, K233951, is a 510(k) premarket notification for the CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw). It is a notification demonstrating substantial equivalence to previously cleared predicate devices, not a study for a new device with new acceptance criteria and a detailed clinical trial. Therefore, most of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (General): The acceptance criteria for this type of submission are typically that the new device does not present a "new worst case" compared to the predicate devices and meets established ASTM standards for spinal implants. The document explicitly states: "For the tested subject devices, the pre-determined acceptance criteria was met for all tests."
Reported Device Performance: The performance data reported is primarily through engineering bench testing according to existing ASTM standards for spinal implants. The document indicates that for tested devices, acceptance criteria were met. For rationalized devices (those where new testing was deemed unnecessary because they do not present a new worst case), the existing predicate data applies.

Acceptance Criteria (Type)	Reported Device Performance
ASTM F1717: Static Compression, Static Torsion, Compression Fatigue (Relevant for spinal system components)	Met pre-determined acceptance criteria for all tested devices.
ASTM F1798: Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing (Relevant for pedicle screw systems)	Met pre-determined acceptance criteria for all tested devices.
ASTM F2503: MRI Compatibility Evaluation	Met pre-determined acceptance criteria for all tested devices.
Device does not present a "new worst case" compared to predicate devices (for rationalized devices). This implies that the performance characteristics (mechanical strength, material compatibility, etc.) are equivalent to or better than the predicate devices, as demonstrated by the existing predicate data or engineering analysis. The subject devices have the same intended use, indications for use, materials, similar overall design, fundamental technology, sterilization, and surgical technique as the predicate devices. The subject and predicate implants have the same function and fundamental scientific technology.	Applicable (existing predicate data is applicable).

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This document refers to bench testing (mechanical, material, MRI compatibility). The "sample size" for such testing is generally a number of physical specimens tested to meet statistical power for engineering analysis, not a patient-based test set as in clinical studies. The document does not specify the exact number of physical samples for each test (e.g., how many screws were tested for axial grip).
- Data Provenance: This is engineering test data, not patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is an engineering test of spinal implant components, not an AI or diagnostic device requiring expert interpretation of medical images or patient data to establish ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies or performance studies where multiple readers or experts assess outcomes. This is bench testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a spinal implant device, not an AI or diagnostic software. Therefore, an MRMC study or AI assistance is not relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. For mechanical testing, the "ground truth" is defined by the physical limits and standards outlined in the ASTM protocols (e.g., a screw must withstand a certain load without failure, or a material must not show adverse reactions in an MRI environment).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML model is involved.

Summary of the 510(k) Submission:

This 510(k) submission for the CD Horizon ModuLeX Spinal System focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The primary "study" involved is a series of bench tests (mechanical and MRI compatibility) conducted according to established ASTM standards (F1717, F1798, F2503) for spinal implants. The key "acceptance criterion" for these tests is simply meeting the pre-determined specifications of these standards, and the document states that these criteria were met for all tested devices. For components not subjected to new testing, the justification ("rationalization") relies on the fact that they do not present a "new worst case" compared to previously cleared predicate devices, implying their performance aligns with the existing, cleared data. This type of submission does not involve clinical studies or AI performance evaluations.

Summary

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March 27, 2024

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 logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line.

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

Re: K233951

Trade/Device Name: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 9, 2024 Received: February 9, 2024

Dear Justin 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Image /page/1/Picture/6 description: The image contains the name "Colin O'neill -S" in black font on the left side of the image. On the right side of the image is a light blue logo that appears to be "FDA". The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. The image appears to be a name and logo.

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

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Indications for Use

510(k) Number (if known) K233951

Device Name

CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)

Indications for Use (Describe)

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™M 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, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by turnor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric 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 spondylolisthess 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.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

MEDTRONIC CD HORIZON™ Spinal System

February 09, 2024

I. Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133
Contact Person	Justin O'ConnorPr. Regulatory Affairs SpecialistTelephone Number: (901) 396-3133Email: justin.oconnor(@medtronic.com
Date Prepared	February 09, 2024
II. Name of Device	CD Horizon™ ModuLeXTM Spinal System (Shanks, HeadAssemblies, and Set Screw)
Common Name	Bone Screw, Pedicle Screw
Classification Name	Thoracolumbosacral Pedicle Screw System
Classification	Class II
Product Codes	NKB, KWP, KWQ (888.3070, 888.3060, 888.3050)
III. Predicate Devices	Primary Predicate:CD Horizon™ Spinal System (K221244, S.E. 05/25/2022)Additional Predicates:CD Horizon™ Spinal System (K153442, S.E. 02/18/2016)CD Horizon™ Spinal System (K210637, S.E. 04/30/2021)CD Horizon™ Spinal System (K223494, S.E. 01/23/2023)The predicates have not been subject to a design related recall.
IV. Description	CD Horizon™ Spinal SystemThe 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 titanium alloy medical grade cobalt-chromium-
V. Indications for Use	molybdenum alloy, or medical grade PEEK Optima-LT1. CertainCD Horizon™ Spinal System components may be coated withhydroxyapatite.CD Horizon™ Spinal SystemThe 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 forhooks, when used as an anterolateral thoracic/lumbar system, theCD Horizon™ Spinal System titanium, cobalt chrome, andstainless-steel implants may also be used for the same indicationsas an adjunct to fusion. With the exception of DDD, CD Horizon™Legacy™ 3.5mm rods and associated components may be used forindications in skeletally mature patients as an adjunct to fusion. The3.5mm rods may be used for the specific pediatric indications noted.When used for posterior non-cervical pedicle screw fixation inpediatric patients, CD Horizon™ Spinal System titanium, cobaltchrome, and stainless-steel implants are indicated as an adjunct tofusion to treat progressive spinal deformities (i.e. scoliosis,kyphosis, or lordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the CD Horizon™Spinal System is intended to treat pediatric patients diagnosed withthe following conditions: spondylolisthesis/spondylolysis, fracturecaused by tumor and/or trauma, pseudarthrosis, and/or failedprevious fusion. These devices are to be used with autograft and/orallograft. Pediatric pedicle screw fixation is limited to a posteriorapproach. The CD Horizon™ PEEK rods are intended to provideposterior supplemental fixation when used with an interbody fusioncage for patients diagnosed with DDD. These DDD patients mayalso have up to Grade 1 spondylolisthesis or retrolisthesis at theinvolved level. This device is intended for 1-2 level use in thelumbosacral spine (L2 – S1) in skeletally mature patients. Devices
	spine (T1-S1) as an adjunct to fusion in skeletally mature patients.It is intended for plate fixation/attachment to spinous processes forthe purpose of achieving supplemental fixation in the following
	conditions: DDD, spondylolisthesis, trauma, and/or tumor. Toachieve additional levels of fixation, CD Horizon™ Spinal Systemrods may be connected to the Vertex™ Reconstruction System withthe Vertex™ rod connector. Refer to the Vertex™ Reconstruction
	System package insert for a list of Vertex™ indications.
	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:
VI. Comparison ofTechnologicalCharacteristics withthe Predicate Devices	K221244 (S.E. 05/25/2022) K153442 (S.E. 02/18/2016) K210637 (S.E. 04/30/2021) K223494 (S.E. 01/23/2023)
	The subject and predicate implants have the same function andfundamental scientific technology.
	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.
VII. Performance Data	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.
	Testing and/or Rationales were completed for the following:
	ASTM F1717: Static Compression, Static Torsion,Compression Fatigue ASTM F1798:Axial Grip, Axial Torsion, FlexionExtension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing
	• ASTM F2503: MRI Compatibility Evaluation
	For the tested subject devices, the pre-determined acceptance criteria was met for all tests. For subject devices that are rationalized, all existing predicate data previously provided in the predicate 510(k)s is still applicable.
	Therefore, Medtronic believes the design verification testing demonstrated that the subject devices are substantially equivalent to the predicate devices.
VIII. Conclusion	Based on the supporting evidence provided in this premarket notification, Medtronic believes the subject devices are substantially equivalent to the predicate devices.

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.