EBI LACTOSORB GRAFT CONTAINMENT SYSTEM by EBI, L.P.

The LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The LactoSorb® Graft Containment System is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the LactoSorb® Graft Containment System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving: long bones, flat bones, short bones, irregular bones, appendicular skeleton, thorax and ribs. When used alone (without traditional rigid fixation), the LactoSorb® Graft Containment System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving: tumor resections where bone strength has not been compromised and iliac crest harvests. The device is not intended for use in the spine. The device is not intended for load bearing applications unless used in conjunction with traditional rigid fixation.

Device Description

The LactoSorb® Graft Containment System, a resorbable graft containment system, is made from LactoSorb, which is composed of bioresorbable, and biocompatible polymers that have been used in surgical procedures for years. LactoSorb resorbable copolymer is derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue. Preclinical and clinical studies have proven the safety and effectiveness of these devices. They have been approved to be used in trauma and reconstructive procedures in the midface and craniofacial skeleton, and for maintaining the position of bony fragments or morselized bone graft in iliac crest autograft procedures.

The LactoSorb mesh panel/sheet is provided in sizes of 25 mm x 25 mm to 100 mm x 100 mm and in other shapes and sizes as needed for particular surgical procedures. The thickness of the mesh panel/sheet ranges from 0.50 mm to 2.0 mm, according to the region to be treated, and are provided with and without macro porous holes. The borders of the mesh panel/sheet may be aligned with holes to attach suture material.

The LactoSorb mesh panel/sheet can be malleable and shaped to conform to the specific anatomy. The mesh panel/sheet can be heated to a malleable state using a hot sterile/saline water bath (K011237) or a sterile LactoSorb® Heat Pack (K941245). The mesh panel/sheet can be cut into various shapes and sizes. EBI heat contouring pen can also be used for both cutting and insitu shaping of the mesh panel/sheet. The mesh panel/sheet can be used either alone or in conjunction with fixation devices such as resorbable sutures, screws and rivets to keep the device in place. Various manual instruments are available to implant the LactoSorb® Graft Containment System.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (EBI LactoSorb® Graft Containment System), not a study report detailing acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.

The document primarily focuses on establishing "substantial equivalence" of the EBI LactoSorb® Graft Containment System to previously marketed predicate devices, which is a regulatory pathway for class II medical devices in the US. It does not present de novo performance data from a clinical trial or algorithm validation study.

Here's what can be inferred from the document regarding the device and its regulatory submission:

Device: EBI LactoSorb® Graft Containment System, a resorbable graft containment system made from LactoSorb (polylactic/polyglycolic acid copolymer).
Intended Use: To maintain the relative position of weak bony tissue (bone grafts, bone graft substitutes, or bone fragments from comminuted fractures). Also indicated for cement restriction in total joint arthroplasty procedures. Can be used with or without traditional rigid fixation depending on the application and anatomical location. Not for use in the spine or for load-bearing unless with traditional rigid fixation.
Regulatory Pathway: 510(k) premarket notification, seeking substantial equivalence.
Predicate Devices: Several MacroPore, Synthes, Biomet, and Lorenz devices were cited as predicates.
Safety and Effectiveness: The document states, "Preclinical and clinical studies have proven the safety and effectiveness of these devices." However, these studies are not described in the provided text. It refers to the well-established nature of LactoSorb material and its prior use in other approved devices.
Comparison to Predicate: The submitter asserts "There are no significant differences between the EBI LactoSorb® Graft Containment System and the following predicate devices: [...] The LactoSorb® Graft Containment System is substantially equivalent to the predicate devices in regards to intended use, material and function."

In summary, the provided text does not contain the specific details required to fill out the table and answer the questions related to acceptance criteria and a study proving device performance as it is a regulatory submission focused on substantial equivalence rather than a performance study report.

Summary

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AUG 1 6 2004

Ko339/8 page 1 of

510(k) Summary

This 510(k) Summary of Safety and Effectiveness for the EBI LactoSorb® Graft Containment System is provided as required per Section 513(I)(3) of the Food, Drug and Cosmetic Act.

Submitter: Jon Caparotta, RAC Contact Person: Frederic Testa, RAC Manager Regulatory Affairs Telephone: 973-299-9300, EBI, L.P. ext.2208 100 Interpace Parkway Fax: 973-257-0232 Parsippany, NJ 07054

Date prepared: August 9, 2004

EBI LactoSorb® Graft Containment System 2. Proprietary Name: Common Name: Plate, Bonc Classification Name/Code: HRS
1. Predicate or legally marketed devices that are substantially equivalent:
- MacroPore OS Trauma System, K021164 by MacroPore, Inc. �
- . MacroPore OS Protective Sheet, K994158 by MacroPore, Inc.
- . Synthes Resorbable Meshes & Sheets, K003788 by Synthes (USA).
- . Lorenz LactoSorb Panels and Fasteners K011139 by Biomet, Inc.
- Biomet LactoSorb Panels and Fasteners K984390 by Biomet, Inc. .
- . LactoSorb Trauma Plating System, K992355 by Biomet, Inc.
Device Description: The LactoSorb® Graft Containment System, a resorbable graft containnent বঁ system, is made from LactoSorb, which is composed of bioresorbable, and biocompatible polymers that have been used in surgical procedures for years. LactoSorb resorbable copolymer is derived from lactic and glycolic acids. Polylactic/polyglycolic acid copolymer degrades and resorbs in vivo by hydrolysis to lactic and glycolic acids, which are then metabolized by the body. The LactoSorb material has been found in animal and clinical studies to be biocompatible in both soft tissue and bone tissue. Preclinical and clinical studies have proven the safety and effectiveness of these devices. They have been approved to be used in trauma and reconstructive procedures in the midface and craniofacial skeleton, and for maintaining the position of bony fragments or morselized bone graft in iliac crest autograft procedures.

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K033918 pg-xf

in place. Various manual instruments are available to implant the LactoSorb® Graft Containment System.

Intended Use: The LactoSorb® Graft Containment System is intended to maintin the relative เก้ position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from work position of weak bony rissue such as bone graits, bone gran is also indicated for cement comminuted fractures. The Lactorol - Grate Commission with traditional rigid fixation, the LactoSorb® Graft Containment System is intended to maintain the relative rigid Tixation, the Lactosord "Orar Constituctive orthopedic procedures involving: Nong bones, flat bones, short bones, irregular bones, appendicular skeleton and thorax. When used alone (without traditional rigid fixation), the LactoSorb® Graft Containment System is intended to maintain the relative position of bone graft or bone graft substitutes in here and hour orthopedic procedures involving: tumor resections where bone strength has not been orthopedic procedures inverting. This device is not intended for use in the spins. The compromised and mac crest marrests. This ever and in conjunction with traditional rigid fixation.

Comparison to the Predicate Device: 6.

There are no significant differences between the EBI LactoSorb® Graft Containment System and the following predicate devices:

MacroPore OS Trauma System, K021164 by MacroPore, Inc. .
MacroPore OS Protective Sheet, K994158 by MacroPore, Inc. ◆
Synthes Resorbable Meshes & Sheets, K003788 by Synthes (USA). .
Lorenz LactoSorb Panels and Fasteners K011139 by Biomet, Inc. �
Biomet LactoSorb Panels and Fasteners K984390 by Biomet, Inc. .
LactoSorb Trauma Plating System, K992355 by Biomet, Inc. .

The LactoSorb® Graft Containment System is substantially equivalent to the predicate devices in regards to intended use, material and function.

*Any statement made in conjunction with this submission of substantial couranial courance to any other product in intented only to relater the product can be lawfolly market approval of a column on an is not incolner in not is not incolusion intended only to relate the product can be be bayon the locus infined by Picked by Picked is not Pical it has big result in the Market Market Market Market Market Ma to be interpreted as an admission of ally outch 1996 of United in patin and the many of the 42520 (Docket No. 70N-0355.))

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2004

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

Re: K033918

Trade Name: EBI LactoSorb® Graft Containment System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: May 27, 2004 Received: May 28, 2004

Dear Mr. Caparotta:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard) the enactment date of the Medical Device American processes of to connine.co. phor to May 20, 1978, are encordance with the provisions of the Federal Food, Drug, de necs that have been recises in quire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, dicrore, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is exassinod (tional controls. Existing major regulations affecting your device can may be subject to back as back as a submit ons, 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 r icast of advised that i Dri brounder of our device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must or any I cacharter and tegeranents, 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) I his letter will anow you to begin marketing your antial equivalence of your deversits your day premarket nothication. The FDA multig of backantal vija.
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 If you desire specific advice for your ac 1100 on ease note the regulation entitled, Contact the Office of Compilance as (s st ) >> (21CFR Part 807.97) you may obtain.
"Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMISOranuning of Tererence to premation on your responsibilities under the Act may be obtained from the Other general information on your responsional 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 A. Wilkinson

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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Page of

510(k) Number (if known):

Device Name: EBI LactoSorb® Graft Containment System

Indications For Use:

(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)

Mark A. Miller
(Division Sign Off)

Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K033918

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.