EBI P148 SPINAL FIXATION SYSTEM by EBI, L.P.

The EBI® PI48 Spinal Fixation System is a single use spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization of spinal segments, 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), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

Device Description

The EBI® P148 Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, couplers and hooks. 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.

AI/ML Overview

This document is a 510(k) summary for the EBI® P148 Spinal Fixation System. It establishes substantial equivalence to predicate devices and describes the intended use and materials. However, this document does not contain information about acceptance criteria or a study proving device performance against such criteria.

The provided text focuses on:

Device Identification: Proprietary name, common name, classification names.
Predicate Devices: Lists EBI® Omega 21™ Spinal Fixation System and Webb-Morley Spine System as predicates.
Device Description: Single-use spinal fixation device utilizing rods, screws, couplers, and hooks.
Intended Use/Indications for Use: Detailed descriptions for pedicle screw fixation, posterior hook and sacral/iliac screw fixation, and anterior fixation, specifying spinal segments and conditions treated.
Materials: Titanium alloy (Ti-6A1-4V ELI) and unalloyed titanium.
Comparison to Predicate Devices: States "no significant differences" in intended use, materials, and function for substantial equivalence.
FDA Communication: A letter from the FDA confirming the finding of substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving the device meets them because this data is not present in the provided text.

To answer your request, I would need a different document that details the performance studies conducted for the EBI® P148 Spinal Fixation System, including:

Acceptance Criteria: Specific performance thresholds (e.g., in terms of strength, fatigue life, biocompatibility) the device must meet.
Study Design: Details of mechanical testing (e.g., static, fatigue), animal studies, or clinical trials.
Reported Device Performance: The actual results obtained from these studies.
Sample Sizes and Data Provenance: For any test sets used.
Ground Truth Establishment: If applicable for human-in-the-loop or standalone AI studies (which is not relevant for a mechanical fixation device).
Adjudication Method: If applicable.
MRMC or Standalone Studies: If applicable.
Training Set Information: If applicable.

Summary

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510(k) Summary

This 510(k) Summary for the EB1® P148 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
Date prepared: May 5, 2003

2. Proprietary Name:	EBI® P148 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:

EBI® Omega 21™ Spinal Fixation System .
Webb-Morley Spine System .
1. Description of the device: The EBI® P148 Spinal Fixation System is a single use spinal fixation device that utilizes rods, screws, couplers and hooks.
1. Intended Use: The EBI® P148 Spinal Fixation System is a single use spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

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When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, 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) degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocations; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis: fracture: previous failed fusion: or tumor resection.

When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion: or tumor resection.

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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® Omega21™ Spinal Fixation System and the currently marketed EBI Omega21 Spinal Fixation System. It is substantially equivalent* to the predicate devices in regards to intended use, materials, and function.

* 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 market approval or reclassification and is not 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/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

Public Health Service

JUN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jon Caparotta, RAC Manager, Regulatory Affairs EBI, L.P. 100 Interpace Parkway Parsippany, NJ 07054

Re: K031423

Trade/Device Name: EBI® P148 Spinal Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNH, KWP, KWQ, MNI Dated: May 5 2003 Received: May 6, 2003

Dear Mr. Caparotta:

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. Jon Caparotta, 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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.

for Mark N. Millheam

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): K031423

Page I of

Device Name: EBI® P148 Spinal Fixation System

Indications For Use:

The EBI® PI48 Spinal Fixation System is a single use spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine.

(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) OR

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

Regulation Number and Section

N/A