EBI TOP LOADING MAS SPINAL FIXATION SYSTEM by EBI, L.P.

The EBI® Top Loading MAS 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.

Device Description

The EBI® Top Loading MAS Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EBI® Top Loading MAS Spinal Fixation System. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document primarily focuses on establishing substantial equivalence to predicate devices, describing the device, its intended use, materials, and product classification. There is no performance data or study methodology presented.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input.

Summary

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JAN 1 3 2004

K033312

1.72

510(k) Summary

This 510(k) Summary for the EBI® Top Loading MAS Spinal Fixation System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.

Contact Person: Frederic Testa, RAC 1. Submitter: EBI, L.P. Telephone: (973) 299-9300, ext.2208 100 Interpace Parkway Parsippany, NJ 07054
October 8, 2003 Date prepared:

2. Proprietary Name:	EBI® Top Loading MAS Spinal Fixation System
Common Name:	Spinal Fixation Device
Classification Names:	Spondylolisthesis Spinal Fixation Device SystemSpinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation Orthosis

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

Webb-Morley Spine System .
EBI Omega21 Spinal Fixation Device .
EBI P148 Spinal Fixation Devcie .
Zielke VDS System ●
1. Description of the device: The EBI® Top Loading MAS Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, and hooks.
1. Intended Usc: The EBI® Top Loading MAS Spinal Fixation System is a noncervical 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

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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.

1. Materials: The components of the System are manufactured from titanium alloy (Ti-6A1-4V ELI) per ASTM F136 and unalloyed titanium per ASTM F 67-00.
1. Comparison of the technological characteristics of the device to predicate devices: There are no significant differences between the proposed EBI® Top Loading MAS Spinal Fixation System and the predicate devices. It is substantially equivalent* to the predicate devices 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 to whether 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 infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Public Health Service

JAN 1 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033312

Trade/Device Name: EBI® Top Loading MAS Spinal Fixation System Trade/Device Name: 277-17-2888.3050,21 CFR 888.3070,21 CFR 888.3060 Regulation Names: 21 CF R 800:5000;27 +60 Corporation orthosis, Pedicle screw spinal system. Spinal intervertebral body fixation orthosis Regulatory Class: II

Product Codes: NKB, MNH, MNI, KWQ, KWP Dated: October 9, 2003 Received: October 15, 2003

Dear Mr. Testa:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your Section 310(t) personalially 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 commerce provide to May 20, 7778, as econdance with the provisions of the Federal Food. Drug. devices that have been reclassified in assessman of a premarket approval application (PMA). allo Cosmetic Act (Act) that do not requent to the general controls provisions of the Act. The I ou may, mercere, maniel and tees, coos, coos, coos, coosenents for annual registration, listing of general controls provisions of tactice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMAI. it If your device is classified (500 abs. 1970) with the major regulations affecting your device can Inay be subject to suel additional controller , Title 21, Parts 800 to 898. In addition, FDA may oc found in the Obacements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised hat I DA is issuares of a cevice complies with other requirements of the Act that I DA has made a determinatives administered by other Federal agencies. You must of any I citizal statutes und regations and admited to: registration and fisting ( 12 comply with an the Not 31equirements(01): good manufacturing practice requirements as set CFR Part 807), additing (21 CFR Part 807), good if and if applicable. the electronic forul in the quarts 355tems ($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($($

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Page 2 - Mr. Frederic Testa, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher with anow you to oegh finding of substantial equivalence of your device to a legally prematics notification: "The Presults 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 desire specific as not as (301) 594-4659. Also, please note the regulation entitled. Connect the Ories of Comment of premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 yours,

Mark N Millman

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

510(k) Number (if known):

Device Name: EBI® Top Loading MAS Spinal Fixation System

Indications For Use:

The EBI® Top Loading MAS 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 skelctally mature patients. The device is indicated for all of the following indications regardless of the intended use: degencrative disc discase (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformitics or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous 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)

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

f Mark n Milkemas

Restorative
Devices

K033

Regulation Number and Section

N/A