CD Horizon™ Astute™ Spinal System: The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 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.

CD Horizon™ Fenestrated Screw Set: When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion. Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion. When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set may be used with any cleared traditional CD Horizon™ Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD Horizon™ Growth Rod Conversion Set may not be used with PEEK rods, Spire™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

CD HORIZON™ Spinal System: 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, 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 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 pedictic patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic 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. 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 (12 - 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. 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 the Vertex™ indications of use.

GDLH™ Posterior Spinal System: The GDLH™ Posterior Spinal System, when using TSRH™ variable angle screws, is intended only for patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed or attached to the lumbar and sacral spine: and (d) having the device removed after the development of a solid fusion mass. When properly used. this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the lumbar and sacral spine via a posterior surgical approach in a GDLH™ construct for the treatment of severe spondylolisthesis (Grade 4) at the L5-S1 vertebral joint, the specific indications for the GDLH™ Posterior Spinal System are the following: Degenerative disc disease (DDD - as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule). Pseudoarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and lordosis. Fracture. Unsuccessful previous attempts at spinal fusion. Tumor resection. Nota bene: the GDLH™ Posterior Spinal System is limited to non-cervical use. TSRH™ variable angle with the GDLH™ Posterior Spinal System, are intended for sacral/iliac attachment only. GDLH™ hooks and Crosslink™ bars are intended for posterior thoracic and/or lumbar use only.

COLORADO 2™ Spinal System: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Colorado 2™ Spinal System is indicated for one or more of the following: ( ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (5) kyphosis, (6) spinal tumor, and/or (7) pseudarthrosis. In addition, when used as a pedicle screw fixation system, the Colorado 2™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Colorado 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection. When used as an anterolateral thoracic/lumbar system, the Colorado 2™ Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, kyhosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset seculiosis, which are associated with or at risk of thoracic insufficiency syndrome. The Shilla™ Growth Guidance System is intended to be removed after skeletal maturity.

TENOR™ Spinal System: The Tenor™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) having the device removed after the development of a solid fusion mass. Note: Tenor™ Plates are intended for the L5-S1 pedicle screw indication only. The Tenor™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: Degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). Pseudarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and/or lordosis. Fracture. Tumor resection. When used for posterior non-pedicle screw fixation. the Tenor™ Spinal System is intended for thoracic, lumbar, and sacral (T1- Sacrum) fixation only.

Device Description

CD HORIZON™ ASTUTE™ SPINAL SYSTEM: The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK). Medical grade titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct. Only use set screws designed for use with CD Horizon™ Astute™ rods. PEEK implants may be used with titanium alloy or cobaltchromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal System rods are not to be used with Crosslink™M plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients. To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ Growth Rod Conversion Set: The CD Horizon™ Growth Rod Conversion Set consists of a variety of inline connectors used with certain CD Horizon™ Spinal System components to create posterior pedicle screw and hook constructs intended for treatment of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set is used with CD Horizon™ Spinal System rods (ranging in diameter from 3.5mm to 5.5mm), pedicle screws, hooks, and connectors of various sizes. These implants are used to form a distinct spinal construct in growing children to correct spinal deformities in a non-fusion manner. Similar to CD Horizon™ implants used in fusion cases, these components are rigidly locked into a variety of configurations with each construct being tailor-made for the individual. As the patient grows, subsequent lengthening surgeries are performed periodically to reapply tension/distraction to the construct. These surgeries are repeated until the child has reached skeletal maturity, at which point the implants may be removed. Certain components within the CD Horizon™ Spinal System are excluded for use in pediatric patients and, therefore, are excluded for use with the CD Horizon™ Growth Rod Conversion Set. These include PEEK rods, Shape Memory Alloy Staples and Spire™ Plates. All screws used in pediatric cases are only cleared for use via a posterior approach. CD Horizon™ Growth Rod Conversion Set components are fabricated from medical grade stainless steel or titanium alloy. Compatible CD Horizon™ Spinal System implant components are fabricated from medical grade stainless steel, medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. 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. To achieve best results, do not use any of the CD Horizon™ Growth Rod Conversion Set implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

CD HORIZON™ SPINAL SYSTEM: The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, Crosslink™ plates, and connecting components. 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, Spire™ plates. Screws used in pediatric cases are only cleared for use via a posterior approach. All 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; Crosslink™ bar and connectors and Medtronic multi-axial rods and screws. Note that 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 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. 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. 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.

CD Horizon™ Fenestrated Screw Set: The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) > bone > > cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion. These implants may also serve as traditional pedicle screws when used without bone cement in patients. CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct. CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobaltchromium-molybdenum alloy. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System.

COLORADO 2™ SPINAL System: The Colorado 2TM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. Colorado 2TM implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case. Colorado 2TM Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire system may be fabricated from medical grade titanium or titanium alloy. The titanium version of the Colorado 2TM Spinal System is used in conjunction with GDLHTM φ5.5 rods, TSRHTM Spinal System rods and TenorTM Spinal System rods. To achieve best results, do not use Colorado 2TM Spinal System implant components with components from any other system or manufacturer. Never use stainless steel and titanium implant components in the same construct.

GDLH™ POSTERIOR SPINAL SYSTEM: The GDLHTM Posterior Spinal System consists of a variety of shapes and sizes of rods, hooks, and connecting components. TSRHTM variable angle screws may also be used with the GDLHTM Posterior Spinal System. GDLHTM implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. GDLHTM Posterior Spinal System implant components are fabricated from medical grade stainless steel described by ASTM Standard F 138, Grade 2 (commonly called 316 LVM Stainless Steel) or ISO 5832-1 or ISO 5832-9. This material is not compatible with titanium, MP35NTM1 or any other alloy. Alternatively, GDLH TM Posterior Spinal System implant components are fabricated from titanium alloy (Ti-6Al-4V) such as described by ASTM F136 or ISO 5832-3. Implant components made from different metal alloys must not be used together in a construct. Medtronic expressly warrants these devices are fabricated from the foregoing material specifications. To achieve the best results, do not use GDLHTM Posterior Spinal System components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic implants, none of the GDLH Posterior Spinal System components should ever be reused under any circumstances.

SHILLA™ Growth Guidance System: The Shilla™ Growth Guidance System consists of stainless steel components used to form a distinct spinal construct in growing children. The Shilla™ Growth Guidance System set screw provides attachment of a spinal pedicle screw to a spinal rod. Unlike a typical set screw, which rigidly locks the vertical rod inside the connector housing to the pedicle screw, the Shilla™ Growth Guidance System set screw captures the rod within the screw housing, but does not fix it rigidly to the pedicle screw. The Shilla™ Growth Guidance System consists of a construct that includes 4.5mm or 5.5mm diameter rods, fixed angle and multi-axial screws, and CrosslinkTM plates. Additionally, the construct may be supplemented with sublaminar wire. Shilla™ Growth Guidance System implants are provided non-sterile. Shilla™ Growth Guidance System implants are not to be used with implants from other systems. Never use stainless steel and titanium implant components in the same construct.

TENOR™ SPINAL SYSTEM: The Tenor™ Spinal System consists of a variety of shapes and sizes of rods, screws, bolts, clamps, connectors, plates, cross-connectors, washers, and nuts. The Tenor™ Spinal System may be used with GDLH™ 5.5mm rods, TSRHTM hooks and connectors, TSRH™ Low Profile Crosslink™ plates, CD Horizon™ Low Profile Multispan™ Crosslink™ plates, and/or Multi-axial Low Profile Multi-span™ Crosslink™ plates for attachment to the posterior thoracic and lumbar spine. All screws/bolts in this system are 5.5mm in diameter or larger. Implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Tenor™ Spinal System implants are fabricated from medical grade titanium alloy. Alternatively, the entire system may be manufactured from medical grade stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use Tenor™ Spinal System implants with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document.

AI/ML Overview

This document, K221646, describes an MRI update for several Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems. The stated intention of the submission is to harmonize language in certain sections (Visual Inspection, Packaging, Cleaning & Sterilization, Cleaning & Decontamination, and Sterilization) across all 8 package inserts, claiming these changes do not impact related specifications and therefore require no further verification or validation testing.

The performance data provided focuses entirely on MRI safety testing, indicating that the device's main "performance" in this context is its MRI compatibility rather than clinical effectiveness for spinal fixation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
MRI Safety	Magnetically Induced Displacement Force: Evaluation according to ASTM F2052:2015.	The subject Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems "were evaluated for MR-safety in accordance with" ASTM F2052:2015. (Implied compliance with the standard's criteria, as the submission states this testing supports substantial equivalence).
	Magnetically Induced Torque: Evaluation according to ASTM F2213:2017.	The subject Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems "were evaluated for MR-safety in accordance with" ASTM F2213:2017. (Implied compliance with the standard's criteria).
	MR Image Artifacts: Evaluation according to ASTM F2119:2007(Reapproved 2013).	The subject Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems "were evaluated for MR-safety in accordance with" ASTM F2119:2007(Reapproved 2013). (Implied compliance with the standard's criteria).
	Radiofrequency Induced Heating: Evaluation according to ASTM F2182:2019e2.	The subject Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems "were evaluated for MR-safety in accordance with" ASTM F2182:2019e2. (Implied compliance with the standard's criteria).
	Labeling for MR Safety: Adherence to ASTM F2503 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment".	The Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems "have been labeled in accordance with ASTM F2503". (Implied compliance).
Sterilization	Not explicitly stated as acceptance criteria, but previous premarket notifications indicated safety and effectiveness.	"Not applicable. Based on the supporting documentation provided in previous premarket notifications, the subject Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems are as safe and effective." (No specific testing or performance data presented in this document for sterilization, but relies on prior clearances).
Harmonization of Package Inserts	Ensure consistency between Visual Inspection, Packaging, Cleaning & Sterilization, Cleaning & Decontamination, and Sterilization sections across all 8 package inserts without impacting related specifications.	"In this submission language in following sections is harmonized to ensure consistency between all 8 package inserts: Visual Inspection, Packaging, Cleaning & Sterilization, Cleaning & Decontamination, and Sterilization. These changes do not impact related specifications and therefore there is no need for further verification or validation testing". (Claim of successful harmonization).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly mentioned for the MRI testing samples. Typically, these tests involve a representative number of device components or assemblies, but the exact count is not provided.
Data Provenance: Not specified. It's likely these tests were conducted in a laboratory setting, not necessarily involving human or animal data. The origin of the testing facility (country) is not provided. The study is prospective in the sense that the testing was performed specifically for this submission to demonstrate MRI compatibility.

3. 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)

This document describes physical product testing (MRI compatibility), not a clinical study involving human interpretation where "ground truth" would be established by experts. Therefore, this information is not applicable. The ground truth is determined by the objective measurements performed during the standardized engineering tests (ASTM standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This document describes physical product testing, not a clinical study requiring adjudication of expert opinions. Therefore, this information is not applicable.

5. 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

No MRMC comparative effectiveness study was done. This submission focuses on the MRI compatibility of spinal implants, not diagnostic performance with or without AI assistance. Therefore, this information is not applicable.

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

No standalone algorithm performance study was done. This submission is for spinal implants, not AI algorithms. Therefore, this information is not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the MRI safety testing, the "ground truth" is established by the physical phenomena and measurements defined by the ASTM standards (e.g., magnetic field strength, temperature measurements, image artifact measurements). It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

9. How the ground truth for the training set was established

This submission describes physical product testing, not the development or training of an AI algorithm. Therefore, this information is not applicable.

Summary

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October 4, 2022

Image /page/0/Picture/1 description: The image shows the logo for 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Medtronic Sofamor Danek USA, Inc. Shana Foster Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K221646

Trade/Device Name: CD HORIZON™ ASTUTE™ SPINAL SYSTEM: CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLHTM POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWQ, KWP, NQP, PGM Dated: September 6, 2022 Received: September 12, 2022

Dear Shana Foster:

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.

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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 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.

for

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) K221646

Device Name CD HORIZON™ ASTUTE™ Spinal System

Indications for Use (Describe)

CD Horizon™ Astute™ Spinal System

The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 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.

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)

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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:

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510(k) Number (if known)

K221646

Device Name CD Horizon™ Fenestrated Screw Set

Indications for Use (Describe)

CD Horizon™ Fenestrated Screws

When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are 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, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion.

Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.

When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life

expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

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)

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510(k) Number (if known) K221646

Device Name CD HORIZON™ Growth Rod Conversion Set

Indications for Use (Describe)

CD Horizon™ Growth Rod Conversion Set

The CD Horizon™ Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set may be used with any cleared traditional CD Horizon™ Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD Horizon™ Growth Rod Conversion Set may not be used with PEEK rods, Spire™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Number (if known) K221646

Device Name CD HORIZON™ Spinal System

Indications for Use (Describe)

CD Horizon™ Spinal System

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, 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 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 pedictic patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic 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. 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 (12 - 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.

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 the Vertex™ indications of use.

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.

{6}------------------------------------------------

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

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510(k) Number (if known) K221646

Device Name GDLH™ Posterior Spinal System

Indications for Use (Describe)

GDLH™ Posterior Spinal System

The GDLH™ Posterior Spinal System, when using TSRH™ variable angle screws, is intended only for patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed or attached to the lumbar and sacral spine: and (d) having the device removed after the development of a solid fusion mass.

When properly used. this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the lumbar and sacral spine via a posterior surgical approach in a GDLH™ construct for the treatment of severe spondylolisthesis (Grade 4) at the L5-S1 vertebral joint, the specific indications for the GDLH™ Posterior Spinal System are the following:

· Degenerative disc disease (DDD - as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).

Pseudoarthrosis.
· Stenosis.
· Spondylolisthesis.
· Spinal deformities such as scoliosis, kyphosis, and lordosis.
· Fracture.
· Unsuccessful previous attempts at spinal fusion.
· Tumor resection.

Nota bene: the GDLH™ Posterior Spinal System is limited to non-cervical use. TSRH™ variable angle with the GDLH™ Posterior Spinal System, are intended for sacral/iliac attachment only. GDLH™ hooks and Crosslink™ bars are intended for posterior thoracic and/or lumbar use only.

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)

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510(k) Number (if known)

K221646

Device Name COLORADO 2™ Spinal System

Indications for Use (Describe)

Colorado 2TM Spinal System

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

In addition, when used as a pedicle screw fixation system, the Colorado 2™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Colorado 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection. When used as an anterolateral thoracic/lumbar system, the Colorado 2™ Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e. scoliosis, kyhosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection.

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)

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{9}------------------------------------------------

510(k) Number (if known) K221646

Device Name SHILLATM Growth Guidance System

Indications for Use (Describe)

Shilla™ Growth Guidance System

The Shilla™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset seculiosis, which are associated with or at risk of thoracic insufficiency syndrome. The Shilla™ Growth Guidance System is intended to be removed after skeletal maturity.

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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{10}------------------------------------------------

510(k) Number (if known) K221646

Device Name TENOR™ Spinal System

Indications for Use (Describe)

Tenor™ Spinal System

The Tenor™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) having the device removed after the development of a solid fusion mass. Note: Tenor™ Plates are intended for the L5-S1 pedicle screw indication only.

The Tenor™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications:

• Degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).

· Pseudarthrosis.
· Stenosis.
· Spondylolisthesis.
· Spinal deformities such as scoliosis, kyphosis, and/or lordosis.
· Fracture.
Tumor resection.

When used for posterior non-pedicle screw fixation. the Tenor™ Spinal System is intended for thoracic, lumbar, and sacral (T1- Sacrum) fixation only.

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)

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510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems October 4, 2022

Submitter:	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person:	Shana FosterRegulatory Affairs Specialist
Date Prepared:	October 4, 2022
Name of Device:	Medtronic ThoracoLumboSacral Anterior &Posterior Spinal Fixation Systems1. CD HORIZON™ ASTUTE™ SPINALSYSTEM2. CD HORIZON™ Growth Rod ConversionSet3. CD HORIZON™ SPINAL SYSTEM4. CD Horizon™ Fenestrated Screw Set;Applies to US only parts5. COLORADO 2™ SPINAL System6. GDLH™ POSTERIOR SPINALSYSTEM7. SHILLA™ Growth Guidance System8. TENOR™ SPINAL SYSTEM
Common Name (withtarget populationintended for MRIconstruct)	CD HORIZON™ ASTUTE™ SPINALSYSTEM: Rods & Set Screws CD HORIZON™ Growth Rod Conversion Set:Set Screws & Connectors CD HORIZON™ SPINAL SYSTEM: Rods,Staples, Screws, Set Screws, Bolts,Connectors/Dominos, Hooks, Nut Caps, Plates,Sliders, Washers, Staples, Crosslinks, RodStoppers, Spacer, C-Rings, Nuts
	CD Horizon™ Fenestrated Screw Set: Screws
	COLORADO 2™ SPINAL System: Connectors,Crosslinks, Screws, Set Screws, Plates, Clamps,Dominos, Hooks, Nuts, Rods, Staples
	GDLH™ POSTERIOR SPINAL SYSTEM:Connectors, Crosslinks, Rods, Hooks & SetScrews
	SHILLA™ Growth Guidance System: SetScrews, Screws, Rods & Crosslinks
	TENOR™ SPINAL SYSTEM: Clamps,Connectors, Hooks, Crosslinks, Nuts, Rods &Screws
Regulatory Class,Regulation Number,Regulation Name andDevice Product Code:	KWP, KWQ, NKB, NQP, PGM1. 21 CFR 888.3050 Device Class II KWP -Appliance, Fixation, Spinal Interlaminal2. 21 CFR 888.3060 Device Class II KWQ -Appliance, Fixation, Spinal Intervertebral Body)3. 21 CFR 888.3070 Device Class II See indentedlist below:a. NKB - Thoracolumbosacral Pedicle ScrewSystemb. NQP - Posterior Metal/Polymer SpinalSystem, Fusionc. PGM - Growing Rod System
Trade Name:	1. CD HORIZON™ ASTUTE™ SPINALSYSTEM2. CD HORIZON™ Growth Rod ConversionSet3. CD HORIZON™ SPINAL SYSTEM4. CD Horizon™ Fenestrated Screw Set;Applies to US only parts5. COLORADO 2™ SPINAL System
	6. GDLH™ POSTERIOR SPINALSYSTEM
	7. SHILLA™ Growth Guidance System
	8. TENOR™ SPINAL SYSTEM
Predicate Devices:	• Primary Predicate 1- K201407 CD Horizon™ SpinalSystem (S.E. 09/10/2020)
	• Predicate 2- K191066 CD HORIZON™ ASTUTE™SPINAL SYSTEM (S.E. 10/03/2019)
	• Predicate 3- K150200 CD HORIZON Growth RodConversion Set (S.E. 02/25/2015)
	• Predicate 4- K201362 CD Horizon™ FenestratedScrew Set, CD Horizon™ Spinal System, Kyphon™HV-R™ Bone Cement (S.E. 08/19/2020)
	• Predicate 5- K030875 MODIFICATION TOCOLORADO 2SPINAL SYSTEM (S. E. 06/24/2003)
	• Predicate 6- K954645 TITANIUM GDLHPOSTERIOR SPINAL SYSTEM (S.E. 01/16/1996)
	• Predicate 7- K140750 SHILLA GROWTHGUIDANCE SYSTEM (S.E. 07/17/2014)
	• Predicate 8- K022191 MODIFICATION TO TENORSPINAL SYSTEM (S.E. 08/28/2002)
Description of Devices:	CD HORIZON™ ASTUTE™ SPINALSYSTEM
	The CD Horizon™ Astute™ Spinal System consists of avariety of sizes of rods, as well as set screws, which areused with bone screws from the CD Horizon™ Solera™Spinal System, to create a variety of rigidly lockedconfigurations, with each construct being tailored to theindividual case.
	CD Horizon™ Astute™ Spinal System implantcomponents are fabricated from medical grade titaniumalloy, tantalum, or polyetheretherketone (PEEK).
	Medical grade titanium, titanium alloy, or medical gradecobalt-chromium-molybdenum alloy may be usedtogether. Never use titanium, titanium alloy, or medicalgrade cobalt-chromium-molybdenum alloy with stainless

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PEEK implants may be used with titanium alloy or cobaltchromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal System rods are not to be used with Crosslink™M plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients. To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. CD HORIZON™ Growth Rod Conversion Set The CD Horizon™ Growth Rod Conversion Set consists of a variety of inline connectors used with certain CD Horizon™ Spinal System components to create posterior pedicle screw and hook constructs intended for treatment of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set is used with CD Horizon™ Spinal System rods (ranging in diameter from 3.5mm to 5.5mm), pedicle screws, hooks, and connectors of various sizes. These implants are used to form a distinct spinal construct in growing children to correct spinal deformities in a non-fusion manner. Similar to CD Horizon™ implants used in fusion cases, these components are rigidly locked into a variety of configurations with each construct being tailor-made for the individual. As the patient grows, subsequent lengthening surgeries are performed periodically to reapply tension/distraction to the construct. These surgeries are repeated until the child has reached skeletal maturity, at which point the implants may be removed. Certain components within the CD Horizon™ Spinal System are excluded for use in pediatric patients and, therefore, are excluded for use with the CD Horizon™ Growth Rod Conversion Set. These include PEEK rods, Shape Memory Alloy Staples and Spire™ Plates. All

steel in the same construct. Only use set screws designed

for use with CD Horizon™ Astute™ rods.

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screws used in pediatric cases are only cleared for use viaa posterior approach.CD Horizon™ Growth Rod Conversion Set componentsare fabricated from medical grade stainless steel ortitanium alloy. Compatible CD Horizon™ Spinal Systemimplant components are fabricated from medical gradestainless steel, medical grade titanium, titanium alloy,and/or medical grade cobalt-chromium-molybdenumalloy.Medical grade titanium, titanium alloy, and/or medicalgrade cobalt-chromium-molybdenum alloy may be usedtogether. Never use titanium, titanium alloy, and/ormedical grade cobalt-chromium-molybdenum alloy withstainless steel in the same construct.To achieve best results, do not use any of the CDHorizon™ Growth Rod Conversion Set implantcomponents with components from any other system ormanufacturer unless specifically allowed to do so in thisor another Medtronic document.
CD HORIZON™ SPINAL SYSTEM
The CD Horizon™ Spinal System consists of a variety ofshapes and sizes of rods, hooks, screws, Crosslink™Plates, staples, and connecting components, as well asimplant components from other Medtronic spinal systemswhich can be rigidly locked into a variety ofconfigurations, with each construct being tailor-made forthe individual case.A subset of CD Horizon™ Spinal System componentsmay be used for posterior pedicle screw fixation inpediatric cases. These constructs may be comprised of avariety of shapes and sizes of rods (ranging in diameterfrom 3.5mm to 6.35mm), hooks, screws, Crosslink™plates, and connecting components. Similar to the CDHorizon™ implants used in adult cases, these componentscan be rigidly locked into a variety of configurations, witheach construct being tailor-made for the individual case.Certain components within the CD Horizon™ SpinalSystem are specifically excluded for use in pediatricpatients. These include PEEK rods, Spire™ plates. Screwsused in pediatric cases are only cleared for use via a
posterior approach. All 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; Crosslink™ bar and connectors and
Medtronic multi-axial rods and screws. Note that 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 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.
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.
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.

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CD Horizon™ Fenestrated Screw Set

The CD Horizon™ Fenestrated Screw Set consists of a variety of cannulated screws. These screws contain a series of fenestrations which allows polymethylmethacrylate (PMMA) > bone > > cement (Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement) to be injected into the treated site. This cement is used to augment screw fixation into the pedicle in patients whose life expectancy is of insufficient duration to permit achievement of fusion.

These implants may also serve as traditional pedicle screws when used without bone cement in patients.

CD Horizon™ Fenestrated Screws are specifically designed to connect to appropriate rods and associated connecting components contained within the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert for information regarding those implants. Care should be taken so the correct components are used in the spinal construct.

CD Horizon™ Fenestrated Screw Set implant components are fabricated from medical grade titanium and/or medical grade titanium alloy and/or medical grade cobaltchromium-molybdenum alloy. Never use stainless steel and titanium implant components in the same construct.

To achieve best results, do not use CD Horizon™ Fenestrated Screw implants with components from any system other than the CD Horizon™ Spinal System.

COLORADO 2™ SPINAL System

The Colorado 2TM Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. Colorado 2TM implant components can be rigidly locked into a variety of configurations, with each construct being tailormade for the individual case. Colorado 2TM Spinal System implant components are fabricated from medical grade stainless steel. Alternatively, the entire

{18}------------------------------------------------

system may be fabricated from medical grade titaniumor titanium alloy.
The titanium version of the Colorado 2TM SpinalSystem is used in conjunction with GDLHTM φ5.5 rods,TSRHTM Spinal System rods and TenorTM SpinalSystem rods. To achieve best results, do not useColorado 2TM Spinal System implant components withcomponents from any other system or manufacturer.Never use stainless steel and titanium implantcomponents in the same construct.
GDLHTM POSTERIOR SPINAL SYSTEM
The GDLHTM Posterior Spinal System consists of avariety of shapes and sizes of rods, hooks, and connectingcomponents. TSRHTM variable angle screws may also beused with the GDLHTM Posterior Spinal System. GDLHTMimplant components can be rigidly locked into a variety ofconfigurations, with each construct being tailor-made forthe individual case.
GDLHTM Posterior Spinal System implant components arefabricated from medical grade stainless steel described byASTM Standard F 138, Grade 2 (commonly called 316LVM Stainless Steel) or ISO 5832-1 or ISO 5832-9. Thismaterial is not compatible with titanium, MP35NTM1 orany other alloy. Alternatively, GDLH TM Posterior SpinalSystem implant components are fabricated from titaniumalloy (Ti-6Al-4V) such as described by ASTM F136 orISO 5832-3. Implant components made from differentmetal alloys must not be used together in a construct.Medtronic expressly warrants these devices are fabricatedfrom the foregoing material specifications.
To achieve the best results, do not use GDLHTMPosterior Spinal System components with componentsfrom any other system or manufacturer unlessspecifically allowed to do so in this or another Medtronicdocument. As with all orthopaedic implants, none of theGDLH Posterior Spinal System components should everbe reused under any circumstances.
SHILLATM Growth Guidance System

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The Shilla™ Growth Guidance System consists of stainless steel components used to form a distinct spinal construct in growing children. The Shilla™ Growth Guidance System set screw provides attachment of a spinal pedicle screw to a spinal rod. Unlike a typical set screw, which rigidly locks the vertical rod inside the connector housing to the pedicle screw, the Shilla™ Growth Guidance System set screw captures the rod within the screw housing, but does not fix it rigidly to the pedicle screw. The Shilla™ Growth Guidance System consists of a construct that includes 4.5mm or 5.5mm diameter rods, fixed angle and multi-axial screws, and CrosslinkTM plates. Additionally, the construct may be supplemented with sublaminar wire. Shilla™ Growth Guidance System implants are provided non-sterile. Shilla™ Growth Guidance System implants are not to be used with implants from other systems. Never use stainless steel and titanium implant components in the same construct. TENOR™ SPINAL SYSTEM The Tenor™ Spinal System consists of a variety of shapes and sizes of rods, screws, bolts, clamps, connectors, plates, cross-connectors, washers, and nuts. The Tenor™ Spinal System may be used with GDLH™ 5.5mm rods, TSRHTM hooks and connectors, TSRH™ Low Profile Crosslink™ plates, CD Horizon™ Low Profile Multispan™ Crosslink™ plates, and/or Multi-axial Low Profile Multi-span™ Crosslink™ plates for attachment to the posterior thoracic and lumbar spine. All screws/bolts in this system are 5.5mm in diameter or larger. Implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Tenor™ Spinal System implants are fabricated from medical grade titanium alloy. Alternatively, the entire system may be manufactured from medical grade stainless steel. Never use stainless steel and titanium implant components in the same construct. To achieve best results, do not use Tenor™ Spinal System implants with components from any other system or

{20}------------------------------------------------

	manufacturer unless specifically allowed to do so in thisor another Medtronic document.
Indications for Use:	CD HORIZONTM ASTUTETM SPINALSYSTEM
	The CD HorizonTM AstuteTM Spinal System is intended toprovide for posterior, supplemental fixation when usedwith an interbody fusion cage for patients diagnosed withdegenerative disc disease (DDD- defined as back pain ofdiscogenic origin with degeneration of the disc confirmedby history and radiographic studies). These DDD patientsmay also have up to Grade 1 spondylolisthesis orretrolisthesis at the involved level. This device is intendedfor 1-2 level use in the lumbosacral spine (L2 – S1) inskeletally mature patients. The device is intended for usewith an interbody fusion cage at the instrumented leveland is not intended for stand-alone use.
	CD HORIZONTM Growth Rod Conversion Set
	The CD HorizonTM Growth Rod Conversion Set isindicated in patients with potential for additional spinalgrowth under 10 years of age who require surgicaltreatment to obtain and maintain correction of severe,progressive, life-threatening, early-onset spinaldeformities associated with thoracic insufficiencyincluding early-onset scoliosis. The CD HorizonTMGrowth Rod Conversion Set may be used with any clearedtraditional CD HorizonTM Spinal System rod constructranging in diameter from 3.5mm to 5.5mm, with theexception of PEEK Rod constructs. The CD HorizonTMGrowth Rod Conversion Set may not be used with PEEKrods, SpireTM Spinous Process Plates, or Shape MemoryAlloy (SMA) Staples.
	CD HORIZONTM SPINAL SYSTEM
The CD HorizonTM Spinal System with or withoutSextantTM instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the followingindications: degenerative disc disease (DDD - defined asback pain of discogenic origin with degeneration of thedisc confirmed by history and radiographic studies),spondylolisthesis, trauma (i.e. fracture or dislocation),spinal stenosis, curvatures (i.e. scoliosis, kyphosis, orlordosis), tumor, pseudarthrosis, and/or failed previousfusion.
Except for hooks, when used as an anterolateralthoracic/lumbar system, CD HorizonTM Spinal Systemtitanium, cobalt chrome, and stainless steel implants mayalso be used for the same indications as an adjunct tofusion.
With the exception of DDD, CD HorizonTM LegacyTM3.5mm rods and associated components may be used forthe aforementioned indications in skeletally maturepatients as an adjunct to fusion. The 3.5mm rods may beused for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screwfixation in pediatric patients, CD HorizonTM SpinalSystem titanium, cobalt chrome, and stainless steelimplants are indicated as an adjunct to fusion to treatprogressive spinal deformities (i.e. scoliosis, kyphosis, orlordosis) including idiopathic scoliosis, neuromuscularscoliosis, and congenital scoliosis. Additionally, the CDHorizonTM Spinal System is intended to treat pediatricpatients diagnosed with the following conditions:spondylolisthesis/ spondylolysis, fracture caused bytumor and/or trauma, pseudarthrosis, and/or failedprevious fusion. These devices are to be used withautograft and/or allograft. Pediatric pedicle screw fixationis limited to a posterior approach.
The CD HorizonTM PEEK rods are intended to provideposterior supplemental fixation when used with aninterbody fusion cage for patients diagnosed with DDD.These DDD patients may also have up to Grade 1spondylolisthesis or retrolisthesis at the involved level.This device is intended for 1-2 level use in the lumbosacralspine (L2 – S1) in skeletally mature patients. The deviceis intended for use with an interbody fusion cage at theinstrumented level and is not intended for stand-alone use.

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The CD Horizon™ Spire™ plate is a posterior, singlelevel, 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 previously spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the VertexTM Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.

CD Horizon™ Fenestrated Screw Set

Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization and stabilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.

When used in conjunction with Medtronic HV-RTM Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD Horizon™ Fenestrated Screws augmented with Medtronic HV-RTM Fenestrated Screw Cement or Kyphon™ Xpede™ Bone

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Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

COLORADO 2™ SPINAL System

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

In addition, when used as a pedicle screw fixation system, the Colorado 2TM Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbarfirst sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass.

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

When used as an anterolateral thoracic/lumbar system, the Colorado 2TM Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection.

GDLH™ POSTERIOR SPINAL SYSTEM

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The GDLHTM Posterior Spinal System, when usingTSRHTM variable angle screws is intended only forpatients (a) having severe spondylolisthesis (Grades 3and 4) of the fifth lumbar-first sacral (L5-S1) vertebraljoint; (b) receiving fusions using autogenous bone graftonly; (c) having the device fixed or attached to the lumbarand sacral spine: and (d) having the device removed afterthe development of a solid fusion mass.
When properly used, this system is intended to assiststabilization until a solid spinal fusion develops. Exceptfor situations where screws are attached to the pediclesof the lumbar and sacral spine via a posterior surgicalapproach in a GDLHTM construct for the treatment ofsevere spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for theGDLHT™ Posterior Spinal System are the following:1. Degenerative disc disease (DDD - as defined byinstability in the presence of one or more of thefollowing: osteophyte formation, decrease in discspace height, endplate sclerosis, disc herniations,facet joint changes, and scarring and/or thickeningof the annulus fibrosis, ligamentum flavum, orfacet joint capsule).2. Pseudoarthrosis.3. Stenosis.4. Spondylolisthesis.5. Spinal deformities such as scoliosis, kyphosis, andlordosis.6. Fracture.7. Unsuccessful previous attempts at spinal fusion.8. Tumor resection.
Nota bene: the GDLHTM Posterior Spinal System islimited to non-cervical use. TSRHT™ variable angle whenused with the GDLHTM Posterior Spinal System, areintended for sacral/iliac attachment only. GDLHTM hooksand Crosslink™ bars are intended for posterior thoracicand/or lumbar use only.
SHILLAT™ Growth Guidance System
The Shilla™ Growth Guidance System is indicated forskeletally immature patients less than 10 years of age withthe potential for additional spinal growth who require

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surgical treatment for correction and maintenance of thecorrection of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, whichare associated with or at risk of thoracic insufficiencysyndrome. The ShillaTM Growth Guidance System isintended to be removed after skeletal maturity.
TENORTM SPINAL SYSTEM
The TenorTM Spinal System, when used for pedicle screwfixation, is intended only for patients: (a) having severespondylolisthesis (Grades 3 and 4) of the fifth lumbar –first sacral (L5-S1) vertebral joint; (b) receiving fusionsusing autogenous bone graft only; (c) having the devicefixed to the lumbar and sacral spine (levels of pediclescrew fixation may be from L3 to sacrum); and (d) havingthe device removed after the development of a solid fusionmass.Note: TenorTM Plates are intended for the L5-S1 pediclescrew indication only.The TenorTM Spinal System, when used as a posterior,non-pedicle screw fixation system, is intended for thefollowing indications:Degenerative disc disease (DDD - as defined by backpain of discogenic origin with degeneration of the discconfirmed by patient history and radiographicstudies). Pseudarthrosis. Stenosis. Spondylolisthesis. Spinal deformities such as scoliosis, kyphosis, and/orlordosis. Fracture. Tumor resection. When used for posterior non-pedicle screw fixation, theTenorTM Spinal System is intended for thoracic, lumbar,and sacral (T1 – Sacrum) fixation only.
Comparison ofTechnologicalCharacteristics with thePredicate Devices:	The subject devices do not differ from thetechnological characteristics of the predicatedevices.
Performance Data:	The following performance data were provided insupport of substantial equivalence:

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MRI Testing:
	In accordance with the FDA Guidance"Establishing Safety and Compatibility of PassiveImplants in the Magnetic Resonance(MR) Environment" the subject MedtronicThoracoLumboSacral Anterior & Posterior SpinalFixation Systemswere evaluated for MR-safety in accordance withthe following standards:
	• ASTM F2052:2015– “Standard test method formeasurement of magnetically induceddisplacement force on passive implants in themagnetic resonance environment”
	• ASTM F2213:2017– “Standard test method formeasurement of magnetically induced torque onmedical devices in the magnetic resonanceenvironment”
	• ASTM F2119:2007(Reapproved 2013)–“Standard test method for evaluation of MRimage artifacts from passive implants”
	• ASTM F2182:2019e2– “Standard test methodfor measurement of radio frequency inducedheating on or near passive implant duringmagnetic resonance imaging”
	The Medtronic ThoracoLumboSacral Anterior &Posterior Spinal Fixation Systemshave been labeled in accordance with ASTMF2503 “Standard Practice for Marking MedicalDevices and Other Items for Safety in theMagnetic Resonance Environment”.
	• FDA Guidance for Industry and FDA Staff"Establishing Safety and Compatibility of PassiveImplants in the Magnetic Resonance (MR)Environment" issued December 11, 2014
	• FDA Guidance for Industry and FDA Staff“Assessment of Radiofrequency- Induced Heatingin the Magnetic Resonance (MR) Environment for

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	Multi-Configuration Passive Medical Devices”issued March 22, 2016
	Sterilization Testing:Not applicable. Based on the supportingdocumentation provided in previous premarketnotifications, the subject MedtronicThoracoLumboSacral Anterior & Posterior SpinalFixation Systems are as safe and effective.
Conclusion:	In this submission language in following sectionsis harmonized to ensure consistency between all 8package inserts: Visual Inspection, Packaging,Cleaning & Sterilization, Cleaning &Decontamination, and Sterilization. Thesechanges do not impact related specifications andtherefore there is no need for further verificationor validation testing

K221646 Page 17 of 17

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.