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), tumor, pseudarthrosis, and or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediativ indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by 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 (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

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

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

The PASS LP™ Spinal System is a pedicle screw fixation system intended for immobilization 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates and caps for sacral plates, when non-cervical pedicle screw fixation in pediatric patients, the PASS LP™ Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The CD Horizon Spinal System and PASS LP™ Spinal System (including UNiD™ Patient Specific Rods) consist of a variety of shapes and size of rods, hooks, screws, crosslink, plates, staples and connecting components, as well as implants 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.

The purposes of this submission are to:

Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

UNiD™ Patient Specific Rods are manufactured in titanium alloy Ti-6AI-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications, or in cobalt chrome alloy Co-Cr28Mo6 conforming to ISO 5832-12 specifications and ASTM F1537 specifications.

UNiD™ Patient Specific Rods are differentiated in two subgroups: UNiD™ Patient Specific Standard Rods (UNiD ROD) and UNiD™ Patient Specific Percutaneous Rods (UNiD™ Patient Specific Rods have been designed and manufactured for one specific patient. UNiD™ Patient Specific Rods must be used during surgery for this patient only and must not be reused (single use only). The UNiD™ Patient Specific Rods 4.75 diameter rods are not compatible with the PASS LP system. For a complete guide to the system, it is important to refer to the surgical technique.

AI/ML Overview

Please find the information regarding the acceptance criteria and study for the device below.

The provided text is a 510(k) Summary for the CD Horizon™ Spinal System and PASS LP™ Spinal System, which are pedicle screw fixation systems. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly for UNiD™ Patient Specific Rods. The primary purpose of this submission is to add UNiD™ Patient Specific Rods (new diameter 4.75mm) and to change the proprietary Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient Specific Rods."

The testing conducted is for mechanical equivalence, not clinical performance or diagnostic accuracy. Therefore, concepts like sensitivity, specificity, accuracy, and reader studies (MRMC, standalone algorithm performance) are not applicable to this type of device submission. The acceptance criteria and "performance" here refer to mechanical strength and durability.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (implantable spinal system), the acceptance criteria are based on mechanical properties as per a recognized standard. The document does not provide specific numerical acceptance criteria (e.g., minimum load values) but rather states that testing was conducted in accordance with a standard and demonstrated mechanical equivalence.

Acceptance Criteria (Mechanics)	Reported Device Performance (Mechanics)
Conformity to ASTM F1717-18 for:	Testing confirmed that the subject devices are substantially equivalent to the predicates.
- Static Compression Bending
- Dynamic Compression Bending
- Static Torsion
Mechanical equivalence to predicate devices (K113174 and K140738)	Mechanical equivalence of the subject UNiD™ Patient Specific Rods when used with the CD Horizon™ Spinal System was demonstrated.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. Mechanical testing typically involves a sufficient number of samples (e.g., typically n=5 or n=6 per test condition for medical device mechanical testing) to provide statistically significant results according to the chosen standard (ASTM F1717-18).
Data Provenance: The testing was conducted by Medicrea (Medtronic). It's scientific/engineering test data, not patient data, so 'country of origin' of data or 'retrospective/prospective' doesn't apply in the common clinical sense. The manufacturer is based in France.

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

Number of Experts: Not applicable. Ground truth for mechanical testing is established by recognized engineering standards (ASTM F1717-18) and measured physical properties, not expert consensus.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is mechanical testing data, not human-interpreted data. Results are quantified using laboratory equipment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This type of study is for evaluating the impact of a diagnostic or assistive AI device on human reader performance. This submission is for an implantable medical device, not a diagnostic or AI-driven system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Standalone Study Done: No. This also refers to AI algorithm performance, which is not relevant to this mechanical device submission.

7. Type of Ground Truth Used

Type of Ground Truth: Engineering standards and measurements of mechanical properties. The "ground truth" is adherence to established, validated mechanical test methods (ASTM F1717-18) that ensure the device is "substantially equivalent" in performance to predicate devices.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This concept applies to machine learning models. The manufacturing process of UNiD™ Patient Specific Rods involves patient-specific design (i.e., custom bending for one specific patient based on their anatomy), but this is not an AI "training set."

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

How Ground Truth for Training Set Was Established: Not applicable. No "training set" in the machine learning sense is used here. For the patient-specific rods, the "ground truth" for each rod's design is the specific patient's anatomical requirements, which are determined via medical imaging and planning, not a training set.

Summary

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April 8, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Medicrea International (Medtronic) Ms. Karine Trogneux Regulatory Affairs Manager 5389 Route de Strasbourg - Vancia Rillieux-La-Pape, 69140 France

Re: K220724

Trade/Device Name: CD Horizon™ Spinal System and PASS LP™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: March 8, 2022 Received: March 14, 2022

Dear Ms. Trogneux:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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,

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220724

Device Name CD Horizon™ Spinal System

Indications for Use (Describe)

a posterior approach.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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) K220724

Device Name PASS LPTM spinal system

Indications for Use (Describe)

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.

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

MEDICREA INTERNATIONAL

CD Horizon™ Spinal System and PASS LP™ Spinal System

Date Prepared: April 7th, 2022

I. Submitter and contact Person information
Submitter	MEDICREA INTERNATIONAL (Medtronic)5389 route de Strasbourg - VanciaRILLIEUX-LA-PAPE 69140FR
Contact Person	Karine TrogneuxMEDICREA INTERNATIONAL (Medtronic)5389 route de Strasbourg - VanciaRILLIEUX-LA-PAPE 69140FR
II. Subject Device Information
Trade Name	CD Horizon™ Spinal System
RegulatoryIdentification/Classification	Common Name: Bone Fixation Appliance, Pedicle ScrewProduct Codes: NKB, KWP, KWQRegulation Number: 21 CFR 888.3070Classification Name: Thoracolumbosacral Pedicle Screw SystemDevice Classification: Class II
Trade Name	PASS LP™ Spinal System
RegulatoryIdentification/Classification	Common Name: Bone Fixation Appliance, Pedicle ScrewProduct Codes: NKB, KWPRegulation Number: 21 CFR 888.3070Classification Name: Thoracolumbosacral Pedicle Screw SystemDevice Classification: Class II
III. Predicate and Reference Devices
Primary PredicateDevice	CD Horizon™ Spinal System (K113174, Cleared 11/21/2011)Common Name: Bone Fixation Appliance, Pedicle ScrewProduct Codes: NKB, KWP, KWQ, MNH, MNI, OSHRegulation Number: 21 CFR 888.3070Classification Name: Thoracolumbosacral Pedicle Screw System
Additional predicateDevices	PASS LP™ Spinal System (K140738, Cleared 11/04/2014)Common Name: Spinal Fixation AppliancesProduct Codes: MNI, MNH, KWP, OSHRegulation Number: 21 CFR 888.3070Classification Name: Thoracolumbosacral Pedicle Screw SystemCD Horizon™ Spinal System (K202771, Cleared 10/19/2020)

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Common Name:	Bone Fixation Appliance, Pedicle Screw
Product Codes:	NKB, KWP, KWQ
Regulation Number:	21 CFR 888.3070
Classification Name:	Thoracolumbosacral Pedicle Screw System

Description of Subject Device IV.

The purposes of this submission are to:

Add the UNiD™ Patient Specific Rods (new diameter 4.75mm) to the previously cleared CD Horizon™ Spinal System (K113174, cleared 11/21/2011) and PASS LP™ Spinal System (K140738, cleared 11/04/2014)
Change the propriety Trade Name from "PASS LP™ Patient Specific Rods" to "UNiD™ Patient י Specific Rods"

V.	Indications for Use and Difference Explanation
Indication for Use	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, kyphosis, or lordosis),
	tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system,
the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steelimplants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods andassociated components may be used for indications in skeletally maturepatients as an adjunct to fusion. The 3.5mm rods may be used for thespecific pediatric indications noted.
When used for posterior non-cervical pedicle screw fixation in pediatricpatients, CD Horizon™ Spinal System titanium, cobalt chrome, andstainless steel implants are indicated as an adjunct to fusion to treatprogressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) includingidiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis.
Additionally, the CD Horizon™ Spinal System is intended to treat pediatricpatients 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 usedwith autograft and/or allograft. Pediatric pedicle screw fixation is limitedto a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posteriorsupplemental fixation when used with an interbody fusion cage forpatients diagnosed with DDD. These DDD patients may also have up toGrade 1 spondylolisthesis or retrolisthesis at the involved level. This deviceis intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletallymature patients. Devices are intended for use with an interbody fusioncage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pediclesupplemental fixation device intended for use in the non-cervical spine(T1-S1) as an adjunct to fusion in skeletally mature patients. It is intendedfor plate fixation/attachment to spinous processes for the purpose ofachieving supplemental fixation in the following conditions: DDD,spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods maybe connected to the Vertex™ Reconstruction System with the Vertex™ rod
	connector. Refer to the Vertex™ Reconstruction System package insert for
	a list of Vertex™ indications

	PASS LP Spinal System
	The PASS LP™ spinal system is a pedicle screw fixation system intended for
	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:
	degenerative disc disease (defined as discogenic back pain with
	degeneration of the disc confirmed by history and radiographic studies),
	spondylolisthesis, trauma (e.g., fracture or dislocation), deformity or
	curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis,
	pseudarthrosis, or failed previous fusion.
	Except for rod plates and caps for sacral plates, when used for posterior
	non-cervical pedicle screw fixation in pediatric patients, the PASS LP™
	Spinal System implants are indicated as an adjunct to fusion to treat
	adolescent idiopathic scoliosis.

	Additionally, the system is intended to treat pediatric patients diagnosed
	with the following conditions: spondylolisthesis/ spondylolysis and fracture
	caused by tumor and/or trauma. The PASS LP™ Spinal System is intended to
	be used with autograft and/or allograft. Pediatric pedicle screw fixation is
	limited to a posterior approach.
VI.	Comparison of Technological Characteristics with the Predicate Devices

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When the subject device UNiD™ Patient Specific Rods (including new diameter 4.75mm) is used with the CD Horizon Spinal System, they have the same fundamental scientific technology, indications for use, intended use, materials, and levels of attachment as the predicate CD Horizon™ Spinal System devices (K113174).

The compatibility between the whole CD Horizon™ Spinal System and PASS LP™ Patient Specific Rods (Diameter 5.5mm and 6.0mm) is already cleared (K202771, Cleared. 10/19/2020).

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The difference between the predicate device CD Horizon™ rods (K113174, cleared 11/21/2011) and subject device is that rods used with the predicate CD Horizon™ Spinal System are cut and bent by the surgeon based on the need of the individual case, while the UNiD™ Patient Specific Rods are directly adapted to a unique patient by means of an industrial bending process prior to distribution for surgery. However, both the subject and predicate systems are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.

In addition, the subject device UNiD™ Patient Specific Rods is directly adapted to a unique patient as the predicate device previously cleared PASS LP™ Spinal System (K140738, Cleared 11/04/2014).

VII. Performance Data (Non-Clinical Test Summary)

In accordance with the Guidance for Industry and FDA Staff – Spinal System 510(k)'s, Medicrea has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. Static and dynamic compression bending and static torsion testing were conducted in accordance with ASTM F1717-18. This performance testing demonstrates mechanical equivalence of the subject UNiD™ Patient Specific Rods when used with the CD Horizon™ Spinal System.

Therefore, Medicrea believes that the testing confirmed that the subject devices are substantially equivalent to the predicates.

VIII. Conclusion

The UNiD™ Patient Specific Rods (including new Diameter 4.75mm) have shown through supporting information provided in this premarket notification to be substantially equivalent to the identified predicates.

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.