The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as an anterolateral pedicle screw fixation system, a posterior hook and sacral/iliac screw fixations ystem, or as an anterplated for pedicle screw fixation system, a posterior november patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographie studiosis, spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, spondylorisations) and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.

The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Firation System is I he EDI Vuel ABS

The EBI® SpineLink II Spinal Fixation System is a non-cervical spinal fixation device intended for use as an anagerolateral The EBT Spinellilik II Spillar I Ration System.
Pedicle screw fixation system, a posterior hook and sacrabiliates. The device is indicated for pedicle screw fixation system, a posterior nosition. In the patientive disactive is indicated for all of the following indications regardess of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studiosis discogenic back pain with defencialism or me
spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, spondylonstrations) in the many psuedoarthrosis, and failed previous fusion.

The EBI® VuePASS™ Portal Access System when used with the EBI® Spinal Fixation The EBI * VuePASS * * Foral 766655 byers.
System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

Device Description

The EBI® Array™ Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks. The EBT® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® Array™ Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of a rod length of 50mm or less and excludes the use of system cross connectors or hooks.

The EBI® SpineLink® II Spinal Fixation System is a fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties. The EBI® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® SpineLink® II Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of link lengths of 36mm or less and excludes the use of system cross links.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EBI® Array™ Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System, and the EBI® SpineLink® II Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission focuses on demonstrating substantial equivalence to existing predicate devices rather than defining specific performance acceptance criteria with numerical targets. The "acceptance criteria" here is implicitly defined as successful implantation demonstrating substantial equivalence in design, intended use, and materials.

Acceptance Criterion (Implicit)	Reported Device Performance
EBI® Array™ System: Substantial equivalence in design, intended use, and materials to the predicate EBI® Array™ Spinal Fixation System (K033312) when utilizing the EBI® VuePASS™ Portal Access Surgical System.	"Verification testing demonstrated successful implantation of the EBI® Array™ Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® Array™ System) "The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772)
EBI® SpineLink® II System: Substantial equivalence in design, intended use, and materials to the predicate EBI® SpineLink® II Spinal Fixation System (K012516, K031355) when utilizing the EBI® VuePASS™ Portal Access Surgical System.	"Verification testing demonstrated successful implantation of the EBI® SpineLink® II Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® SpineLink® II System) "The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772)

Acceptance Criterion (Implicit)

Reported Device Performance

EBI® Array™ System: Substantial equivalence in design, intended use, and materials to the predicate EBI® Array™ Spinal Fixation System (K033312) when utilizing the EBI® VuePASS™ Portal Access Surgical System.

"Verification testing demonstrated successful implantation of the EBI® Array™ Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® Array™ System) "The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772)

EBI® SpineLink® II System: Substantial equivalence in design, intended use, and materials to the predicate EBI® SpineLink® II Spinal Fixation System (K012516, K031355) when utilizing the EBI® VuePASS™ Portal Access Surgical System.

"Verification testing demonstrated successful implantation of the EBI® SpineLink® II Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent to the predicate device in regards to design, intended use, and materials." (For EBI® SpineLink® II System) "The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion." (Intended Use from K042772)

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

The document only generically refers to "Verification testing". It does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically detailed in a separate test report referenced in a 510(k) summary, but not explicitly provided in this summary itself.

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

The document does not mention human experts being used to establish a "ground truth" for a test set. The term "verification testing" implies engineering or mechanical performance testing, not a clinical study involving expert assessment of outcomes or images.

4. Adjudication Method for the Test Set

As there's no mention of a test set requiring expert ground truth or assessment, there is no adjudication method described.

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

No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study would typically involve human readers (e.g., surgeons) evaluating cases with and without AI assistance, and measuring the effect size of the AI's improvement. The device in question (spinal fixation system and portal access system) is a physical surgical device, not a diagnostic AI system, making an MRMC study irrelevant in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithm performance study was done or reported. The devices are physical surgical tools, not algorithms. The "verification testing" would assess the mechanical integrity and functional performance of the surgical tools themselves, likely through bench testing.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context would be the successful mechanical and functional performance of the medical devices as designed, verified through engineering tests matching established predicate device performance and safety standards. This is likely based on engineering specifications and test results.

8. Sample Size for the Training Set

The document does not specify a training set size. This is a physical device, not an AI algorithm that requires a training set in the conventional sense. If any form of "training" or development involved iterative testing, those details are not provided.

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

As this is a physical device submission and not an AI submission, the concept of a "training set" and associated "ground truth" as used in AI development does not apply. The design and development of such devices are guided by engineering principles, biomechanical requirements, materials science, and conformity to established standards for medical implants. "Ground truth" for development would be the known and desired mechanical properties and biological compatibility standards.

Summary

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DEC 1 3 2004

510(k) Summary

This 510(k) Summary for the EBI® Array™ Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

1. Submitter: EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person: Frederic Testa, RACTelephone: (973) 299-9300, ext.2208
--------------------------------------------------------------------------	----------------------------------------------------------------------------

December 2, 2004 Date prepared:

EBI® Array™ Spinal Fixation System with the EBI® 2. Proprietary Name:

VuePASS™ Portal Access Surgical System
----------------------------------------	--	--	--	--

Common Name:	Spinal Fixation Device
Classification Names:	Pedicle Screw Spinal SystemSpinal Interlaminal Fixation OrthosisArthroscope

1. Predicate or legally marketed devices that are substantially equivalent:
  EBI® Array™ Spinal Fixation System (K033312) .
1. Description of the device: The EBI® Array™ Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks. The EBT® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach

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for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® Array™ Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of a rod length of 50mm or less and excludes the use of system cross connectors or hooks.

1. Intended Use: The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
  The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
1. Materials: The components of the EBI® Array™ Spinal Fixation System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and unalloyed titanium per ASTM F 67-00. The components of the EBI® VuePASS™ Portal Access System are manufactured from aluminum alloy as per ASTM B 221, titanium alloy as per ASTM F 136, stainless steel as per ASTM F 899, radel as per ASTM D 4181, and silicone.

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1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® Array™ Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System and the currently marketed EBI® Array™ Spinal Fixation System. Verification testing demonstrated successful implantation of the EBI® Array™ Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent* to the predicate device in regards to design, intended use, and materials.
  * Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any * Any statement made in confuler the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent reclassitication and is not meetised to be interpreted as an actives on any environment final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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510(k) Summary

This 510(k) Summary for the EB1® SpineLink® II Spinal Fixation System with the EB1® VuePASS™ Portal Access Surgical System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

1. Submitter:	EBI, L.P.100 Interpace ParkwayParsippany, NJ 07054	Contact Person:	Frederic Testa, RAC
		Telephone:	(973) 299-9300, ext.2208

December 2, 2004 Date prepared:

EBI® SpineLink® II Spinal Fixation System with 2. Proprietary Name: the EBI® VuePASS™ Portal Access Surgical System

Common Name:	Spinal Fixation Device
Classification Names:	Pedicle Screw Spinal SystemSpinal Interlaminal Fixation OrthosisArthroscope

3. Predicate or legally marketed devices that are substantially equivalent:

• EBI® SpineLink® II Spinal Fixation System	(K012516)
---------------------------------------------	-----------

EBI® SpineLink® II Spinal Fixation System (K031355) .

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1. Description of the device: The EBI® SpineLink® II Spinal Fixation System is a fixation device that utilizes interconnecting links, screws (fixed and polydirectional designs), transverse connectors, hooks, endcaps, locknuts, and link ties. The EBI® VuePASS™ Portal Access Surgical System is a retractor system for a minimally invasive approach for posterior spinal surgery. The system includes a series of stainless steel sequential dilators and various sized reusable radiolucent oval cannulas and circular tubes. When used with the EBI® SpineLink® II Spinal Fixation System, the use of the EBI® VuePASS™ Portal Access Surgical System is limited to the implant of link lengths of 36mm or less and excludes the use of system cross links.
1. Intended Use: The EBI® SpineLink® II Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.

The EBI® VuePASS™ Portal Access System when used with the EBI® SpineLink® II Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.

1. Materials: The components of the EBI® SpineLink® II Spinal Fixation System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136. The components of the VuePASS™ Portal Access Surgical System are manufactured from aluminum alloy as per ASTM B 221, titanium alloy as per ASTM F 136, stainless steel as per ASTM F 899, radcl as per ASTM D 4181, and silicone.

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1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® SpineLink® II Spinal Fixation System with the EBI® VuePASS™ Portal Access Surgical System and the currently marketed EBI® SpineLink® II Spinal Fixation System. Verification testing demonstrated successful implantation of the EBI® SpineLink® II Spinal Fixation System utilizing the EBI® VuePASS™ Portal Access Surgical System. It is substantially equivalent* to the predicate device in regards to design, intended use, and materials.
  * Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate the product can be lawfully marketed without pre-market approval or only produce is mended only to readly interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2004

Mr. Frederic Testa, RAC Regulatory Affairs Project Manager EBI, L.P. 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K042772

KU42 / /2
Trade/Device Name: EBI® Array Spinal Fixation System with VuePASS™ Portal Access
Crade/Device Name: EBI® Array Spinal Fixation System Fixetion System with EDI Array Spinal Pinaux SpineLink® Spinal Fixation System with VuePASS™ Portal Access Surgical System

Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle screw spinal interlaminal fixation orthosis, Regulatory Class: III Product Code: NKB, MNH, MNI, KWP, NBH Dated: November 18, 2004 Received: November 19, 2004

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your becaon 510(x) premainted is substantially equivalent (for the indications ferenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule for regars managed posice Americal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Red Ford Ford. Ford, Day commerce proof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassinod in assess approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I bu may, increrore, market the device, odyde requirements for annual registration, listing of general controls provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Toase oc advised that I Drivesantes syour device complies with other requirements of the Act that I Dri has intates and regulations administered by other Federal agencies. You must of any I cueral statutes and regulations and limited to: registration and listing (21 Compy with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as se CI K Fart 6077, naomig (21 CFR Part 820); and if applicable, the electronic form in the quality byections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will and in yourse FDA finding of substantial equivalence of your device to a legally promation notification of results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attent office of Compliance at (240) 276-__. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general mistmation on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark M. Milkersen

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name:

Device Rainer
EBI® Array Spinal Fixation System with VuePASS™ Portal Access Surgical System

Indications For Use:

The EBI® Array™ Spinal Fixation System is a non-cervical spinal fixation device intended for use as an anterolateral pedicle screw fixation system, a posterior hook and sacral/iliac screw fixations ystem, or as an anterplated for pedicle screw fixation system, a posterior november patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographie studiosis, spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, spondylorisations)
and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.

The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Firation System is I he EDI Vuel ABS

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Millhuser

vision of Gen and Neurological Devices

510(k) Number K042772

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Page

510(k) Number (if known):

Device Name:

EBI® SpineLink® II Spinal Fixation System with VuePASS™ Portal Access Surgical System

Indications For Use:

Prescription Use _ X (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Murle N. Millerson

Neurological Devic

510(k) Number K042772

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.