The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of the spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:

For pedicular use: When used as pedicle screw fixation system of the non cervical posterior spine in skeletally mature patients, these systems are indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Spondylolisthesis
Fracture
Spinal deformities such as scoliosis, kyphosis, lordosis
Tumor
Revision of failed fusion attempts
Pseudarthrosis
Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

Device Description

The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5 mm diameter rods (preformed rod or straight rod configuration) in addition to the selection of the cleared 6.0 mm and 6.35 mm diameter rods. It is to be used with both the Polyaxial and Monoaxial screws.

AI/ML Overview

This is a 510(k) premarket notification for a spinal fixation system, not an AI/ML medical device. Therefore, much of the requested information regarding AI device performance, such as sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies, is not applicable. The provided document focuses on demonstrating substantial equivalence to predicate devices through material, design, and performance data for a new component (5.5 mm diameter rod) of an existing spinal fixation system.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (How the device performed)
Compliance with FDA's Guidance For Spinal System 510(k)	"Engineering analysis and testing to demonstrate compliance with FDA's Guidance For Spinal System 510(k) May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, included the subject component."
Material Properties	"Manufactured from ASTM F-136 implant grade titanium alloy." This implicitly implies the material meets the acceptance criteria for implant grade titanium alloy as defined by ASTM F-136.
Mechanical Performance as per ASTM F 1717	"Performance data per ASTM F 1717 were submitted to characterize the subject ISSYS™ LP Spinal Fixation System components address in this notification." This indicates that the device's mechanical performance was tested according to this standard, and the submitted data (though not detailed here) would demonstrate compliance with the standard's requirements for spinal implant constructs.
Substantial Equivalence to Predicate Devices (Material)	"Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of material..."
Substantial Equivalence to Predicate Devices (Design)	"Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... design..."
Substantial Equivalence to Predicate Devices (Indications)	"Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of... indications for use."

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

Sample Size: Not applicable. This submission is for a physical medical device (spinal fixation system component), not a diagnostic algorithm that uses a "test set" of data in the typical sense. The "testing" refers to mechanical and material characterization.
Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance refers to materials testing and engineering analysis performed according to recognized standards (ASTM F-136, ASTM F 1717). This would typically be conducted in a laboratory setting by the manufacturer or contracted labs.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth from clinical data. The "ground truth" for this device relates to established engineering standards for material properties and mechanical performance.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" as would be used for clinical data interpretation. Compliance is assessed against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for this medical device submission is based on:

Established engineering and material standards: Specifically, ASTM F-136 for material composition (implant grade titanium alloy) and ASTM F 1717 for mechanical performance of spinal implant constructs.
FDA Guidance: The device's design and testing adhered to the "FDA's Guidance For Spinal System 510(k) May 3, 2004."
Predicate Device Characteristics: The core of a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices in terms of material, design, and indications for use. The characteristics of these predicate devices serve as a benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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7. 510(k) Summary

As Required By Section 807.92 (c)

Submitter:	Custom Spine, Inc.1140 Parsippany BlvdSuite 201Parsippany, NJ 07054	DEC 1 3 2007
Contact Person:	Saad AttiyahManager of Regulatory Affairs and Quality AssuranceVoice : (973) 265-5036Fax : (973) 508-0707E-Mail: saad@customspine.com
Date Prepared:	September 27, 2007
Device Class:	III
Classification Name:	Pedicle Screw Fixation System, Spinal Interlaminal Fixation OrthosisPer 21 CFR §888.3070, 21 CFR §888.3050
Classification Panel:	Orthopedics
Product Code:	NKB, KWP, MNI, MNH
Proprietary Name:	ISSYS LP Spinal Fixation System
Predicate Devices:	ISSYSTM LP Spinal Fixation System (K070281)ISSYSTM Pedicle Screw System (K043522)Moss® Miami Spinal System (K933881, K955348, K964024, K983583, K022623)Optima® Spinal System (K031585)
Device Description:	The subject ISSYS LP Polyaxial Spinal Fixation System includes 5.5mm diameter rods (preformed rod or straight rod configuration) inaddition to the selection of the cleared 6.0 mm and 6.35 mm diameterrods. It is to be used with both the Polyaxial and Monoaxial screws
Intended Use:	The ISSYS LP Spinal Fixation System is intended to help provideimmobilization and stabilization of spinal segments as an adjunct tofusion of the lumbar and/or sacral spine, specifically as follows:
	For pedicular use: When used as pedicle screw fixation system of thenon cervical posterior spine in skeletally mature patients, these systemsare indicated for one or more of the following: degenerative

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Special 510(k) Submission - Addition to ISSYS LP Spinal Fixation System

spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition. this system is indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (grade 3 & 4) at the L5-S1 joint having fusion with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation Systems, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
제 Spondylolisthesis
트 Fracture
E Spinal deformities such as scoliosis, kyphosis, lordosis
E Tumor
트 Revision of failed fusion attempts
트 Pseudarthrosis
피 Spinal stenosis

When used in the anterior indication the ISSYS LP Spinal Fixation Systems are indicated for use in the thoracic and lumbar spine.

Materials : Manufactured from ASTM F-136 implant grade titanium alloy.
Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject ISSYS™ LP Spinal Fixation System components address in this notification.

Summary of Technological Characteristics

Documentation is provided which demonstrates the additional 5.5 mm diameter rod of the ISSYS LP Spinal Fixation System to be substantially equivalent to the predicate devices in terms of material, design, and indications for use. Engineering analysis and testing to demonstrate compliance with FDA's Guidance For Spinal System 510(k) May 3, 2004 was completed for the ISSYS LP Spinal Fixation System, included the subject component.

pg 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Public Health Service

DEC 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Custom Spine, Inc. % Mr. Saad Attiyah Manager, Regulatory Affairs & Quality Assurance 1140 Parsippany Blvd., Suite 201 Parsippany, NJ 07054

Re: K072866

Trade/Device Name: ISSYS LP Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, MNI, MNH Dated: December 8, 2007 Received: December 13, 2007

Dear Mr. Attiyah:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 – Mr. Saad Attiyah

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use

510(k) Number (if known):K072866

Device Name: ISSYS LP Spinal Fixation System

Indications For Use:

When used as non pedicular fixation system:

The ISSYS LP Spinal Fixation System, when used as an anterior screw fixation system and posterior sacral/iliac screw fixation system are indicated for the following:

Degenerative disc disease of the thoracic and lumbar spine (defined as back pain of discogenic . origin with degeneration of the disc confirmed by history and radiographic studies).
Spondylolisthesis ●
Fracture .
. Spinal deformities such as scoliosis, kyphosis, lordosis
Tumor .
. Revision of failed fusion attempts
Pseudarthrosis t
Spinal stenosis ●

When used in the anterior indication the ISSYS LP Spinal Fixation System are indicated for use in the thoracic and lumbar spine.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Bneur

510(k) Number Ko72906

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.