The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:
• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e. fracture of dislocation)
• Spinal stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudarthrosis
• Failed previous fusion
The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.
Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

Xia® 3 Spinal System
The Xia® 3 Spinal System is comprised of screws, blockers, and hooks that affix rods and connectors to vertebrae of the spinal column for purposes of stabilization, or corrective action through the application of force.
Xia® 4.5 Spinal System
The Xia® 4.5 Spinal System is comprised of monoaxial and polyaxial bone and reduction screws, hooks, dual staples, and blockers that affix rods, rod-to-rod connectors, and cross connectors to vertebrae of the spinal column.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Stryker Spine Xia® 3 and Xia® 4.5 Spinal Systems. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or data analysis.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices for an expansion of indications for use.

Here's why and what information is available:

The document explicitly states:

"This submission seeks to build upon predicate Xia® 3 and Xia® 4.5 Spinal Systems through expansion of indications only. Therefore, no additional performance data is necessary." (Page 6, "Summary of Performance Data")

This means the submission is not presenting new performance studies or acceptance criteria for a novel device or a significantly modified device. Instead, it's arguing that the expanded indications for the Xia® 3 and Xia® 4.5 Spinal Systems are substantially equivalent to the indications already cleared for a primary predicate device (Medtronic Sofamor Danek, CD HORIZON® Spinal System cleared under K140276) and previous versions of the Xia® systems.

Therefore, for the information requested:

A table of acceptance criteria and the reported device performance: This information is not provided in the document as no new performance data was deemed necessary for this submission. The device is implicitly accepted based on its substantial equivalence to predicate devices, which would have undergone performance testing during their original clearance.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance studies were conducted for this 510(k). The document only mentions predicate device clearances.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a spinal fixation system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) relies on the safety and effectiveness demonstrated by its predicate devices for its original indications and argues that the expanded indications are within the scope of what was already established for similar, legally marketed devices. It is a regulatory submission for a spinal implant, which typically doesn't involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that would generate the detailed data requested in your prompt regarding acceptance criteria, sample sizes, and expert ground truth for an AI/diagnostic device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol composed of three stylized human profiles facing right, with flowing lines extending from the heads.

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

October 21, 2014

Stryker Spine Garry T. Hayeck, Ph.D. Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401

Re: K142381 Trade/Device Name: Xia® 3 and Xia® 4.5 Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP, KWQ Dated: August 25, 2014 Received: August 28, 2014

Dear Dr. Hayeck:

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Ronald#Alean -S for

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

Enclosure

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Indications for Use

510(k) Number (if known) K142381

Device Name Xia® 3 Spinal System

Indications for Use (Describe)

• Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e. fracture of dislocation)
· Spinal stenosis
· Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudarthrosis
· Failed previous fusion

The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.

When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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

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

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K142381

Device Name Xia® 4.5 Spinal System

Indications for Use (Describe)

The Xia® 4.5 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation for the following indications:

· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

· Spondylolisthesis
· Trauma (i.e. fracture of dislocation)
· Spinal stenosis
· Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
Tumor
Pseudarthrosis
· Failed previous fusion

The Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System, and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 Spinal System via the rod-to-rod connector when used for the aforementioned indications in skeletally mature patients as an adjunct to fusion.

Except for the staples, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the Xia® 4.5 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis. kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis. Additionally, the Xia® 4.5 Spinal System is intended to treat pediatic patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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

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

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary: Xia® 3 and Xia® 4.5 Spinal Systems
Submitter	Stryker Spine2 Pearl CourtAllendale, NJ 07401
Contact Person	Garry T. Hayeck, Ph.D.Senior Regulatory Affairs SpecialistPhone: 201-760-8043Fax: 201-760-8406E-mail: garry.hayeck@stryker.com
Date Prepared	October 2, 2014
Trade Names	1. Xia® 3 Spinal System2. Xia® 4.5 Spinal System
Common Name	1. Xia® 3 Spinal SystemSpinal Fixation Appliances2. Xia® 4.5 Spinal SystemSpinal Fixation Appliances
Proposed Class	1. Xia® 3 Spinal SystemClass III2. Xia® 4.5 Spinal SystemClass III
Classification Name,Codification	1. Xia® 3 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2) 2. Xia® 4.5 Spinal System Spinal Interlaminal Fixation Orthosis, 21 CFR § 888.3050 Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 Pedicle Screw Spinal System, 21 CFR § 888.3070 (b) (1) & (b) (2)
Product Codes	1. Xia® 3 Spinal SystemOSH, NKB, KWP, KWQ, MNH, MNI2. Xia® 4.5 Spinal SystemOSH, NKB, KWP, KWQ, MNH, MNI
Predicate Devices	1. Xia® 3 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 3 Spinal System: K113666,133188 2. Xia® 4.5 Spinal System Primary Predicate: Medtronic Sofamor Danek, CD HORIZON®Spinal System: K140276 Additional Predicate: Stryker Spine Xia® 4.5 Spinal System:K121342, 133188
Device Description	1. Xia® 3 Spinal SystemThe Xia® 3 Spinal System is comprised of screws, blockers, and
	hooks that affix rods and connectors to vertebrae of the spinalcolumn for purposes of stabilization, or corrective action throughthe application of force.
	2. Xia® 4.5 Spinal SystemThe Xia® 4.5 Spinal System is comprised of monoaxial and polyaxialbone and reduction screws, hooks, dual staples, and blockers thataffix rods, rod-to-rod connectors, and cross connectors tovertebrae of the spinal column.
Indications for Use	1. Xia® 3 Spinal SystemThe Xia® 3 Spinal System is intended for use in the non-cervicalspine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 SpinalSystem is intended to provide additional support during fusion usingautograft or allograft in skeletally mature patients in the treatmentof the following acute and chronic instabilities or deformities:
	• Degenerative Disc Disease (as defined by back pain ofdiscogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies)• Spondylolisthesis• Trauma (i.e. fracture of dislocation)• Spinal stenosis• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)• Tumor• Pseudarthrosis• Failed previous fusion
	The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and6.0 mm Vitallium rods from the Xia® Spinal System are intended tobe used with the other components of the Xia® 3 Spinal System.
	When used for posterior, non-cervical, pedicle screw fixation inpediatric patients, the Xia® 3 Spinal System implants are indicatedas an adjunct to fusion to treat progressive spinal deformities (i.e.,scoliosis, kyphosis, or lordosis) including idiopathic scoliosis,neuromuscular scoliosis, and congenital scoliosis. Additionally, theXia® 3 Spinal System is intended to treat pediatric patientsdiagnosed with: spondylolisthesis/spondylolysis, fracture caused bytumor and/or trauma, pseudarthrosis, and/or failed previous fusion.This system is intended to be used with autograft and/or allograft.Pediatric pedicle screw fixation is limited to a posterior approach.
	2. Xia® 4.5 Spinal SystemThe Xia® 4.5 Spinal System is intended for anterior/anterolateraland posterior, non-cervical pedicle and non-pedicle fixation forthe following indications:
	• Degenerative Disc Disease (as defined by back pain ofdiscogenic origin with degeneration of the disc confirmed bypatient history and radiographic studies)
	• Spondylolisthesis• Trauma (i.e. fracture of dislocation)• Spinal stenosis• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)• Tumor• Pseudarthrosis• Failed previous fusionThe Stryker Spine DIAPASON™ Spinal System, Opus™ Spinal System,and Xia® 4.5 Spinal System can be linked to the Xia® 4.5 SpinalSystem via the rod-to-rod connector when used for theaforementioned indications in skeletally mature patients as anadjunct to fusion.Except for the staples, when used for posterior non-cervical pediclescrew fixation in pediatric patients, the Xia® 4.5 Spinal Systemimplants are indicated as an adjunct to fusion to treat progressivespinal deformities (i.e., scoliosis, kyphosis, or lordosis) includingidiopathic scoliosis, neuromuscular scoliosis, and congenitalscoliosis. Additionally, the Xia® 4.5 Spinal System is intended totreat pediatric patients diagnosed with:spondylolisthesis/spondylolysis, fracture caused by tumor and/ortrauma, pseudarthrosis, and/or failed previous fusion. This system isto be used with autograft and/or allograft. Pediatric pedicle screwfixation is limited to a posterior approach.
Summary ofTechnologicalCharacteristics	1. Xia® 3 Spinal SystemThe subject Xia® 3 Spinal System shares the same materials,geometries, and fundamental scientific technologies as thepredicate Xia® 3 Spinal System. None of the aforementionedcharacteristics have been altered, augmented, or otherwisechanged.
	2. Xia® 4.5 Spinal SystemThe subject Xia® 4.5 Spinal System shares the same materials,geometries, and fundamental scientific technologies as thepredicate Xia® 4.5 Spinal System. None of the aforementionedcharacteristics have been altered, augmented, or otherwisechanged.
Summary ofPerformance Data	This submission seeks to build upon predicate Xia® 3 and Xia® 4.5Spinal Systems through expansion of indications only. Therefore, noadditional performance data is necessary.
Conclusion	1. Xia® 3 Spinal SystemThe devices of the subject Xia® 3 Spinal System are equivalent inmaterials, geometries, and intended use to the previously clearedXia® 3 Spinal System and CD Horizon System. The expandedindications of the Xia® 3 Spinal System are identical to theindications of the predicate CD Horizon System. We thereforeconclude that the subject Xia® 3 Spinal System is substantiallyequivalent to the identified predicate systems.
	The devices of the subject Xia® 4.5 Spinal System are equivalent inmaterials, geometries, and intended use to the previously clearedXia® 4.5 Spinal System and CD Horizon System. The expandedindications of the Xia® 4.5 Spinal System are identical to theindications of the predicate CD Horizon System. We thereforeconclude that the subject Xia® 4.5 Spinal System is substantiallyequivalent to the identified predicate systems.

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

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