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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio- graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); turnor; pseudarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CDHORIZON 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: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or tumor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Device Description

The purpose of this Traditional 510(k) is to add Threaded Rods to the CD HORIZON® Spinal System.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples and connecting comportents, as well as implant components from other Meduonic 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 diameters from 3.5mm to 6.35mm), hooks, screws. CROSSLINK® Plates, and connecting components. Similarly 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, CD HORIZON® SPIRE spinous process plate devices, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. All screws used in pediatic cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy, and medical grade cobalt-chromiummolybdenum 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, 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 Medironic Multi-Axial rods and screws. Please note that certain components are specifically designed to connect to 3.5mm, 4.5mm, 5.5mm diameter rods or 6.35mm diameter rods, while other components can connect to both 5.5mm rods and 6.35mm diameter rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and 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. The 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 hy-droxyapatite. No warranties expressed or implied are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

Never use stainless steel and titanium implant components in the same construct. Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never use titanium, titanium alloy, and/or medical grade cobaltchromium-molybdenum alloy with stainless steel in the same construct. The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. CD HORIZON@PEEK Rods are not to be used with CROSSLINK@Plates or in pediatric patients. To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

AI/ML Overview

The provided document is a 510(k) summary for the CD HORIZON® Spinal System, specifically for the addition of Threaded Rods. It details the device, its intended use, and the testing conducted to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (from ASTM F1717)	Reported Device Performance
Construct Compression Static Bending	Per ASTM F1717 (2010), "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This typically involves measuring the stiffness and strength of the construct under compressive bending loads. The acceptance criteria would be defined by comparison to the predicate device's performance, ensuring the new device is mechanically equivalent or superior. The specific numerical criteria are not provided in this summary but are implicit in meeting the ASTM standard.	Successfully met all acceptance criteria
Construct Static Torsion	Per ASTM F1717 (2010). This involves measuring the stiffness and strength of the construct under torsional loads. The acceptance criteria would be defined by comparison to the predicate device's performance, ensuring the new device is mechanically equivalent or superior. The specific numerical criteria are not provided in this summary but are implicit in meeting the ASTM standard.	Successfully met all acceptance criteria
Construct Compression Fatigue Bending	Per ASTM F1717 (2010). This involves subjecting the construct to cyclic compressive bending loads to assess its fatigue life and resistance to failure over time. The acceptance criteria would be defined by comparison to the predicate device's performance, ensuring the new device is mechanically equivalent or superior. The specific numerical criteria are not provided in this summary but are implicit in meeting the ASTM standard.	Successfully met all acceptance criteria

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

Sample Size: The document does not specify the exact sample size (number of constructs tested) for each non-clinical test. However, tests were performed "per ASTM F1717 (2010)," which outlines methodologies for such testing. Adherence to a recognized standard suggests appropriate sample sizes were used for mechanical testing to ensure statistical significance, though the exact numbers are not explicitly stated in this summary.
Data Provenance: The data is from non-clinical (benchtop) testing of the device components. Therefore, there is no country of origin for patient data, nor is it retrospective or prospective in a clinical sense.

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

This section is not applicable as the study was non-clinical (benchtop mechanical testing) and did not involve human subjects or expert assessment of clinical data. The "ground truth" in this context is the physical performance of the device against predefined mechanical standards and comparison to predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable as the study was non-clinical (benchtop mechanical testing) and did not involve human experts making judgments on clinical cases. The "adjudication" was based on objective mechanical measurements and comparison against established criteria within the ASTM standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely involved non-clinical benchtop testing of the device's mechanical properties.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This section is not applicable as the device is a medical implant (spinal system components), not an algorithm or software. The "standalone performance" refers to the mechanical performance of the physical device components.

7. The Type of Ground Truth Used:

The "ground truth" used was objective mechanical performance data derived from standardized laboratory tests (ASTM F1717) measuring properties such as static bending, static torsion, and fatigue bending. This data was compared against acceptance criteria presumably established from the performance of legally marketed predicate devices and the requirements of the ASTM standard.

8. The Sample Size for the Training Set:

This section is not applicable. There was no "training set" in the context of machine learning. The device underwent non-clinical mechanical testing.

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

This section is not applicable. There was no "training set" or "ground truth" in the context of an algorithm. The device's performance was evaluated against a recognized industry standard (ASTM F1717) and by comparison to predicate devices; the "ground truth" for the predicate device's performance would have been established similarly through non-clinical mechanical testing at the time of their 510(k) clearances.

Summary

{0}------------------------------------------------

SEP 1 5 2011

CD HORIZON® Spinal System 510(k) Summary August 2011

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

Contact: Kevin Ford Regulatory Affairs Manager

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

III. Classification Names

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

Class: III

Product Code(s): KWP, KWQ, MNI, MNH, NKB, NQP, OSH Regulation No .: 888.3050, 888.3060, and 888.3070

IV. Description

The purpose of this Traditional 510(k) is to add Threaded Rods to the CD HORIZON® Spinal System.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

page 1 of 5

{1}------------------------------------------------

KIII5b.

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, CD HORIZON® SPIRE spinous process plate devices, Shape Memory Alloy Staples, DYNALOK® bolts, and TSRH® screws and washers. All screws used in pediatic cases are only cleared for use via a posterior approach. All of the components used in pediatric cases are fabricated from medical grade stainless steel, medical grade titanium alloy, and medical grade cobalt-chromiummolybdenum alloy.

Page 2 of 5

ਸ਼

{2}------------------------------------------------

In HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt-chromium-molybdenum alloy. Do not use with stainless steel. These staples are not to be used in pediatric patients. PEEK OPTIMA-LT1 implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants. CD HORIZON@PEEK Rods are not to be used with CROSSLINK@Plates or in pediatric patients. To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON® Spinal System components should ever be reused under any circumstances.

V. Indications for Use

Page 3 of 5

{3}------------------------------------------------

الرادي الم

Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Identification of the Legally Marketed Predicate Devices Use to Claim Substantial VI. Equivalence:

Documentation was provided which demonstrated the subject Threaded Rods are substantially equivalent to CD HORIZON® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K.042962 (S.E. 12/14/2004), K.043488 (S.E. 3/21/2005 ), K.091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Additionally, the geomery of the threaded rods are substantially equivalent to the predicate VERTEX® Spinal System threaded rods in K090714 (S.E. 4/17/2009) and K083071 (S.E. 11/14/2008).

VII. Summary of the Technological Characteristics:

The purpose of this Traditional 510(k) is to add a threaded geometry rods on the rod ends of various sizes and varying materials to the CD HORIZON® Spinal System family. The subject and predicate CD HORIZON® Spinal System rods are identical in terms of indications for use, intended use, performance specifications and technological characteristics. The key difference between the subject and predicate device is the addition of a threaded geometry on the rod ends.

Additionally, the geometry of the threaded rods are substantially equivalent to the predicate VERTEX® Spinal System threaded rods in K090714 (S.E. 4/17/2009) and K083071 (S.E. 1 1/14/2008).

VIII. Discussion of Non-Clinical Testing:

The test performed per ASTM F1717 (2010), "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," approved July 1, 2010 was construct compression static bending, construct static torsion, and construct compression fatigue bending.

The subject device successfully met all acceptance criteria for these tests and hence Medtronic believes that documentation provided demonstrates that the CD HORIZON® Spinal System Threaded Rods do not introduce new issues of safety or effectiveness.

page 4 of 5

{4}------------------------------------------------

KIIISIO

Discussion of Clinical Testing: IX. r÷•••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• No clinical testing was performed.

Conclusions Drawn from the Non-Clinical and Clinical Tests: X.

Based on the documentation provided, the subject device is deemed substantially equivalent to the listed predicate devices in terms of fundamental technology, intended use, indications for use, design and fundamental scientific technology.

ર્ત્વ

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2013

Medtronic Sofamor Danek USA, Inc. % Mr. Kevin Ford Regulatory Affairs Manager 1800 Pyramid Place Memphis, Tennessee 38132

Re: K111510

Trade/Device Name: CD HORIZON® Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, NQP, MNI, MNH, KWP, KWQ Dated: August 25, 2011 Received: August 26, 2011

Dear Mr. Ford:

This letter corrects our substantially equivalent letter of September 15, 2011.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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

Page 2 - Mr. Kevin Ford

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/6 description: The image shows the name "Erin Dkeith" in a stylized font. The first name, "Erin," is written in a simple, bold font. The last name, "Dkeith," is written in a more decorative font, with the letters overlapping and embellished with lines and shapes.

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

510(k) Number (if known):

Device Name: CD HORIZON® Spinal System

Indications for Use:

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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio- graphic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); turnor: pseudarthrosis; and/or failed previous fusion. Except for hooks. when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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: degenerative disc disease (as previously defined); spondylolisthesis; trauma; and/or turnor. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.

Prescription Use OR x Per 21 CFR 801.109

Over-The-Counter Use -

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K111510
---------------	---------

CD Horizon® Spinal System Threaded Rods

page	1 of 1	1-15
------	--------	------

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.