The Ti Fenestrated Plate is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The Ti Fenestrated Plate is intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The Ti Fenestrated Plate is attached to the spine posteriorly by means of Songer Cables. The levels of attachment are T1 to L5.

The Ti Fenestrated Plate is indicated for the following:

Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Idiopathic scoliosis.
Kyphotic deformities of the spine.
Lordotic deformities of the spine.
Vertebral fracture or dislocation.
Tumors.
Spondylolisthesis.
Stenosis.
Pseudarthrosis.
Unsuccessful previous attempts at spinal fusion.

Device Description

The Interpore Cross International Ti Fenestrated Plate is a titanium plate containing multiple holes along the length of the plate. The Ti Fenestrated Plate is intended for use in the thoracolumbar spine from T1-L5. The plate is secured to the posterior spine via Songer Cables. The Songer Cables are placed through the holes in the Ti Fenestrated Plate and passed under and around the lamina. The plate and cable(s) are then secured to the spine using a tensioner/crimper instrument to obtain the appropriate tension level and to secure the cable crimp.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. This document is a 510(k) summary for a medical device called the "Ti Fenestrated Plate". It primarily focuses on the device's classification, name, predicate device, indications for use, and a comparison to the predicate device to establish substantial equivalence.

Here's a breakdown of why the requested information is not present:

Acceptance Criteria and Reported Device Performance: This section is completely absent. The document states that the new device has "equivalent biomechanical performance" to the predicate, but it doesn't provide specific quantitative acceptance criteria or detailed performance data for either device.
Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set): None of these details are mentioned. The comparison to the predicate device is a regulatory argument for substantial equivalence, not a clinical or performance study report with the requested metrics.

The 510(k) summary format often focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or detailed performance studies like those seen for novel high-risk devices. Substantial equivalence is often argued based on similar materials, design, intended use, and indications for use, sometimes supplemented with non-clinical (e.g., bench) testing, but not necessarily a full-fledged clinical study with the rigor implied by your questions.

Summary

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510(k) SUMMARY

SUBMITTED BY

Wendy Spielberger Lead, Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200

June 6, 2003

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name:	Appliance, Fixation, Spinal Interlaminal
Common/Usual Name:	Spinal Interlaminal Fixation
Product Classification:	Class II
Proprietary Name:	Ti Fenestrated Plate

PREDICATE DEVICE

Predicate device information is provided in this premarket notification.

INDICATIONS-FOR-USE

The Ti Fenestrated Plate is intended to be used as a temporary construct that assists normal hing and is not intended to replace normal body structures. The Ti Fenestrated Plate is intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.

The Ti Fenestrated Plate is attached to the spine posteriorly by means of Songer Cables. The levels of attachment are T1 to L5.

The Ti Fenestrated Plate is indicated for the following:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
1. Idiopathic scoliosis.
Kyphotic deformities of the spine. 3.
Lordotic deformities of the spine. ব
1. Vertebral fracture or dislocation.
Tumors. 6.
Spondylolisthesis. 7.
1. Stenosis.
Pseudarthrosis. 9.
1. Unsuccessful previous attempts at spinal fusion.

DEVICE DESCRIPTION

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K031772-PIGe 2/2

placed through the holes in the Ti Fenestrated Plate and passed under and around the lamina. The plate and cable(s) are then secured to the spine using a tensioner/crimper instrument to obtain the appropriate tension level and to secure the cable crimp.

COMPARISON TO THE PREDICATE DEVICE

Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the Ti Fenestrated Plate is considered substantially equivalent to the legally marketed predicate device.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

Public Health Service

SEP - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wendy Spielberger, RAC Lead, Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618

Re: K031772

Trade Name: Ti Fenestrated Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: June 6, 2003 Received: June 10, 2003

Dear Ms. Spielberger:

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 - Ms. Wendy Spielberger, RAC

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 Office of Compliance at (301) 594- . 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 Manufacturers, International and Consumer 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 vours.

b Mach A. Mellem

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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510(k) Number (if known):

Device Name: Ti Fenestrated Plate

Indications-For-Use:

The Ti Fenestrated Plate is attached to the spine posteriorly by means of Songer Cables. The levels of attachment are T1 to L5.

The Ti Fenestrated Plate is indicated for the following:

1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
1. Idiopathic scoliosis.
1. Kyphotic deformities of the spine.
1. Lordotic deformities of the spine.
1. Vertebral fracture or dislocation.
1. Tumors.
1. Spondylolisthesis.
1. Stenosis.
1. Pseudarthrosis.
1. Unsuccessful previous attempts at spinal fusion.

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

Prescription Use(PER 21 CFR 801.109)
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	Mark M
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OR
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	Mill
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Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off) 1 Division of General. Restorative and Neurological Devices

KO317772

510(k) Number _

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.