OGM® 1 is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to OGM® 1 and OGM® 1A®. This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data.

OGM® bone cements without Gentamicin
OGM® 1 is polymethylmethacrylate (PMMA) bone cement:

OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

OGM® bone cements with Gentamicin
OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

AI/ML Overview

This document describes the acceptance criteria and study results for two PMMA bone cements, OGM® 1 and OGM® 1A. These devices were evaluated against various standards to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Standard Reference)	Reported Device Performance (OGM® 1 & OGM® 1A)
Mechanical Properties
Stability of liquid component	ISO 5833, ASTM F2118, ASTM F451 requirements	Characterized; ISO 5833 requirements fulfilled; ASTM F451 requirements met; Mechanical characteristics similar to predicate devices in side-by-side testing (ASTM D732, ASTM F2118, ISO 5833)
Maximum Temperature	ISO 5833	Characterized
Setting Time	ISO 5833	Characterized
Intrusion	ISO 5833	Characterized
Compressive Strength	ISO 5833	Characterized
Bending Modulus	ISO 5833	Characterized
Bending Strength	ISO 5833	Characterized
Material/Chemical Properties
Endotoxin	USP Endotoxin Reference Standard (limit value 20 EU/device)	Results meet the limit value (20 EU/device) for both OGM® 1 and OGM® 1A
Gentamicin Release Profile (OGM® 1A)	Compared to predicate device (K023103)	No significant difference observed; Results are similar when compared to predicate device
Antibacterial Efficiency (OGM® 1A)	AATC	Efficient against E. Coli
Chemical Composition (overall)	Similar to predicate devices	Similar, with noted differences in X-ray contrast medium (barium sulfate vs. zirconium dioxide) and presence/absence of chlorophyll. Subject device (OGM® 1A) contains 1g gentamicin sulfate, while primary predicate (Palacos® R+G) contains 0.5g.
X-Ray Contrast Medium	Use of commercialized bone cement X-ray contrast medium	Contains barium sulfate as X-ray contrast medium (both barium sulfate and zirconium dioxide are acceptable for this purpose)
Biocompatibility
Biocompatibility Testing	ISO 10993	Biocompatibility testing performed (cytotoxicity, irritation, acute systemic toxicity, subacute systemic toxicity, implantation, genotoxicity). Results demonstrate biological safety for OGM® 1 (as OGM® 1A regarded as worst case).
Sterilization
Ethylene Oxide Sterilization	ISO 11135	Validated as per ISO 11135
Sterility Assurance	DIN EN ISO 11135-1 and DIN EN ISO 10993-7	Sterilized with an established method (ethylene oxide).

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

The document does not explicitly state the sample sizes for each mechanical or chemical test. The tests were performed "side by side mechanical testing" (page 7, 8) and "subject device and secondary predicate device contains 1g gentamicin sulfate, on the contrary primary predicate device contains 0.5g gentamicin sulfate. Gentamicin sulfate is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens. As per gentamicin sulfate ratio is higher than the primary predicate device antibacterial efficacy can be considered as substantially equivalent to primary predicate device. Antibacterial efficacy tests are performed to subject device. On the other hand, release ratio of Gentamicin is important both in dosage and total release duration. OGM® 1A is subjected to Gentamicin release test comparatively with the predicate device. Lastly, gentamicin has a negative effect on product mechanical and physical properties. ISO 5833 tests are applied to OGM® 1A and demonstrated compliance." (page 12) implying comparative testing.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory-based, non-clinical tests conducted by the manufacturer or a contracted lab.

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

This document describes non-clinical performance and safety testing of a medical device (bone cement). The "ground truth" for these types of studies is typically based on established international standards (e.g., ISO, ASTM, USP) and scientific principles, not on expert consensus interpreting subjective data. Therefore, individual experts are not involved in establishing ground truth in the same way they would be for studies involving diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on objective measurements against established international standards and specifications. There is no subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This document pertains to the premarket notification (510(k)) of a bone cement, which involves non-clinical performance and safety testing, not diagnostic imaging or human-in-the-loop AI assistance.

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

Not applicable. This is a medical device (bone cement), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth for the performance and safety studies is based on:

International Standards: ISO 5833, ASTM F2118, ASTM F451, ISO 11135, ISO 10993, DIN EN ISO 11135-1, DIN EN ISO 10993-7.
Pharmacopoeial Standards: USP Endotoxin Reference Standard.
Antibacterial Testing Standards: AATC.
Comparison to Predicate Devices: For chemical compositions and gentamicin release profiles (OGM® 1A).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.

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

Not applicable, for the same reason as in point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized image of an eagle, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue as well. The logo is simple and professional, and it is easily recognizable.

May 19, 2022

Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve % Mehmet Ormeci Consultant Medcer Uluslararasi Medikal Belgelendirme Anonim Sirketi Taspinar Mahallesi 2800. Caddesi A-2 Apt. No:6 B/49 Ankara, 06830 Turkey

Re: K211869 Trade/Device Name: OGM® 1 OGM® 1A Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, MBB Dated: March 28, 2022 Received: April 8, 2022

Dear Mehmet Ormeci:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For:

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211869

Device Name OGM® 1

Indications for Use (Describe)

OGM® 1 is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K211869

Device Name OGM® 1A

Indications for Use (Describe)

OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows a logo for OGM. The logo is blue and black, and it features the letters "OGM" in a stylized font. Below the letters are the words "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" in a smaller font. The logo is simple and modern, and it is likely used to represent a company or organization.

510k Summary OGM® 1 and OGM® 1A K211869

510(k) Summary

510(k) Submitter Name	ORMED GRUP SAGLIK MEDIKAL TURIZM SAGLIK HIZMETLERI SANAYI VE TICARET LTD. STI.
510(k) Submitter Adress	Macun Mahallesi 177 Sokak No:19 H/7b Yenimahalle, Ankara, TURKEY
510(k) Submitter Telephone No	+90 312 211 01 92
Primary Correspondent Contact Information	Mehmet Fatih Ormeci (Consultant)+90-532-397-3043mformeci@gmail.comFax Number: + 90 312 211 01 93
Summary Preparation Date	03/28/2022

Trade Or ProprietaryName	OGM® 1, OGM® 1A
Common Name	PMMA Bone Cement
Classification Name	Bone Cement
Regulation Name	Polymethylmethacrylate (PMMA) bone cement
Regulation Number	21 CFR 888.3027
Product Code	LOD, MBB
Regulatory Class	Class II

Subject Device 510k No	Primary Predicate Device510k No	Primary Predicate Device Manufacturer
OGM® 1K211869	PALACOS® RK202475	Heraeus Medical GmbHPhilipp-Reis-Str. 8/1361273 Wehrheim Germany
OGM® 1AK211869	PALACOS® R+GK202475	Heraeus Medical GmbHPhilipp-Reis-Str. 8/1361273 Wehrheim Germany

Subject Device 510k No	Seconder PredicateDevice 510k No	Primary Predicate Device Manufacturer
OGM® 1AK211869	DePuy 1 Gentamicin BoneCementK023103	DePuy, Inc.700 Orthopaedic Drive Warsaw, IN 46581

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Device Description:

OGM® bone cements without Gentamicin

OGM® 1 is polymethylmethacrylate (PMMA) bone cement:

OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,

The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid

component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer,

X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene

oxide and sterile filtration).

OGM® bone cements with Gentamicin

OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery, The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

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Image /page/6/Picture/0 description: The image shows the logo for OGM, which is a medical company. The logo is blue and black, and it features the company's name in a stylized font. Below the logo, the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" is written in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and expertise.

Indications For Use:

OGM® 1 is a PMMA bone cement intended for use in arthroplastic procedures of the hip, knee and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

OGM® 1A is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Comparison of technological characteristics:

OGM® 1

Device comparison demonstrated that the OGM® 1 is substantially equivalent to the previously cleared PALACOS® R (K202475) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same or similar technological elements:

PMMA bone cement (same),
Chemical composition (similar),
Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 (same),
Side by side mechanical testing was performed according to the ISO 5833 and ASTM D732. The mechanical characteristics are similar when it is compared with predicate device.
Mixing and application properties (same), and
Clinical use of the devices including the anatomical location of exposure (same) and intended use population (same).

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Image /page/7/Picture/0 description: The image shows the logo for ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI. The logo is blue and black. The logo has the letters OGM in it.

Regarding chemical composition comparison, while the predicate device contains zirconium dioxide, the subject device contains barium sulfate in the cement powder as an X ray contrast medium. Both materials are used in commercialized bone cements as an X ray contrast medium. Chemical formulas between predicate device and subject device have slight differences. The predicate device contains chlorophyll additive serves as marking of the bone cement at the site of the operation. The subject device do not contain chlorophyll, but it is still visible as off white instead of green which chlorophyll provides for predicate device.

OGM® 1A

Device comparison demonstrated that the OGM® 1A is substantially equivalent to the previously cleared PALACOS® G (K202475) and DePuy 1 Gentamicin Bone Cement (K023103) regarding intended use, technological characteristics (device design, material and performance) as well as operating principle. At a high level, the subject device and predicate device are based on the following same or similar technological elements:

PMMA bone cement (same),
Chemical composition (similar),
Sterilized with an established method (ethylene oxide) as per DIN EN ISO 11135-1 and DIN EN ISO 10993-7 (same),
Side by side mechanical testing was performed according to the ASTM F2118, ISO 5833 and ASTM D732. The mechanical characteristics are similar when it is compared with predicate device (K023103).
Mixing and application properties (same) and
Clinical use of the devices including the anatomical location of exposure (same), and intended use population (same).

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Image /page/8/Picture/0 description: The image shows the logo for OGM, which is a medical company. The logo is blue and black, and it features the company's name in a stylized font. Below the logo, the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" is written in a smaller font. The logo is simple and professional, and it conveys the company's focus on medical services.

1g Gentamicin is utilized to powder (similar for primary predicate and same for secondary predicate).
Gentamicin release profiles are compared with the secondary predicate device (K023103) and no significant difference was observed.

Discussion of Non-Clinical Tests:

For the OGM® 1 and OGM® 1A bone cements the stability of liquid component, maximum temperature, setting time, intrusion, compressive strength, bending modulus and bending strength of was characterized per ISO 5833.

Mechanical tests were also performed according to ASTM F2118 standards. ASTM F451 requirements are met.

ATCC antibacterial efficiency testing was performed to OGM 1A.

Endotoxin testing was performed to OGM® 1 and OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device).

EtO sterilization was validated per ISO 11135.

Biocompatibility testing, including cytotoxicity, irritation, acute systemic toxicity, subacute systemic toxicity, implantation and genotoxicity was performed per ISO 10993. Because OGM® 1A can be regarded as worst case product, the results are also valid for OGM® 1.

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Image /page/9/Picture/0 description: The image shows the logo for "OGM", which is in blue and black. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI", which is in a smaller font size. The logo and text are centered in the image.

510k Summary OGM® 1 and OGM® 1A K211869

Substantially Equivalence Discussion

	Subject DeviceK211869	Predicate DeviceK202475	Comparison
Manufacturer	Image: COGM	Image: Heraeus
Device Name	OGM® 1	Palacos® R
Intended Use	OGM® 1 is a PMMA bone cement intendedfor use in arthroplastic procedures of thehip, knee and other joints for the fixationof polymer or metallic prosthetic implantsto living bone.	Palacos® R is indicated for use inarthroplastic procedures of the hip, knee,and other joints for the fixation of polymer ormetallic prosthetic implants to living bone.	same
Components	40g powder (polymer) and 20ml liquid(monomer) is individually packed.	40g powder (polymer) and 20ml liquid(monomer) is individually packed.	same
Sterilization	ethylene oxide and sterile filtration	ethylene oxide and sterile filtration	same
Contact Duration	Permanent / implantable	Permanent / implantable	same
Powder Mass	40g	40g	same
Liquid Volume	20ml	20ml	same
Powder ChemicalComposition	poly(methyl acrylate, methyl methacrylate)35.6 g	poly(methyl acrylate, methyl methacrylate)33.8 g	similar
	Barium sulfate4 g	zirconium dioxide5.9 g	similar
	hydrous benzoyl peroxide0.4 g	hydrous benzoyl peroxide0.3 g	similar
		chlorophyll VIII trace amount	different
Liquid ChemicalComposition	methyl methacrylate19.6 g	methyl methacrylate18.4 g	similar
	N,N-dimethyl-p-toluidine0.4 g	N,N-dimethyl-p-toluidine0.4 g	Same
		liquid: chlorophyll VIII in an oily solutiontrace amount	different
	Hydroquinone trace amount	Hydroquinone trace amount	same

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Image /page/10/Picture/0 description: The image shows the logo for OGM, which is a medical group. The logo is in blue and black, with the letters "OGM" in a stylized font. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI" in a smaller font. The logo is simple and professional, and it is likely used to represent the company's brand.

provides for predicate device. Subject device has been carried out the ISO 5833 performance tests and ISO 10993 biocompatibility tests. ISO 5833 requirements are fulfilled. ISO 10993 test results demonstrates biological safety. Endotoxin testing was performed to OGM® 1 according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device).

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Image /page/11/Picture/0 description: The image shows a logo for a company called "OCM ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI". The logo consists of the letters "OCM" in a stylized font, with a graphic to the left of the letters. The letters are in blue, with a black bar above the "M". Below the letters is the company name in smaller letters.

Substantially Equivalence Discussion

	Subject DeviceK211869	Primary Predicate DeviceK202475	Secondary Predicate DeviceK023103	PrimaryComparison	SecondaryComparison
Manufacturer		Heraeus		-	-
Device Name	OGM® 1A	Palacos® R+G	DePuy 1 Gentamicin BoneCement	-	-
Intended Use	OGM® 1A is indicated for use inthe second stage of a two-stagerevision for total jointarthroplasty after the initialinfection has been cleared.	Palacos® R+G is indicated for use inthe second stage of a two-stagerevision for total joint arthroplastyafter the initial infection has beencleared.	DePuy 1 Gentamicin is indicated foruse in the second stage of a twostage revision for total jointarthroplasty after the initialinfection has been cleared.	same	same
Components	40g powder (polymer) and 20mlliquid (monomer) is individuallypacked.	40g powder (polymer) and 20mlliquid (monomer) is individuallypacked.	40g powder (polymer) and 20mlliquid (monomer) is individuallypacked.	same	same
Sterilization	ethylene oxide and sterilefiltration	ethylene oxide and sterile filtration	ethylene oxide and sterile filtration	same	same
Contact Duration	Permanent / implantable	Permanent / implantable	Permanent / implantable	same	same
Powder Mass	40g	40g	40g	same	same
Liquid Volume	20ml	20ml	20ml	same	same
Powder ChemicalComposition	poly(methyl acrylate, methylmethacrylate)35.6 g	poly(methyl acrylate, methylmethacrylate)33.6 g	poly(methyl acrylate, methylmethacrylate)84.73 (%w/w)	similar	similar
	Barium sulfate4 g	zirconium dioxide6.1 g	Barium sulfate9.10 (%w/w)	similar	similar
	hydrous benzoyl peroxide0.4 g	hydrous benzoyl peroxide0.3 g	hydrous benzoyl peroxide1.95 (%w/w)	similar	similar
	gentamicin base (as sulphate)1 g	gentamicin base (as sulphate)0.5 g	gentamicin base (as sulphate)1 g	different	same
		chlorophyll VIII trace amount		different	same
Liquid ChemicalComposition	methyl methacrylate19.6 g	methyl methacrylate18.4 g	methyl methacrylate98.50 (%w/w)	similar	similar
	N,N-dimethyl-p-toluidine0.4 g	N,N-dimethyl-p-toluidine0.4 g	N,N-dimethyl-p-toluidine< 1.50 (%w/w)	same	similar
		liquid: chlorophyll VIII in an oilysolution trace amount		different	same
	Hydroquinone trace amount	Hydroquinone trace amount	Hydroquinone trace amount	same	same

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Image /page/12/Picture/0 description: The image contains a logo for OGM, which is in blue and black. Below the logo is the text "ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI". The text is in a smaller font size than the logo. The logo is simple and modern.

Regarding chemical composition comparison, while the primary predicate device contains zirconium dioxide, the subject device contains barium sulfate in the cement powder as an X ray contrast medium. On the other hand, secondary predicate device contains barium sulfate as the subject device. Both materials are used in commercialized bone cements as an X ray contrast medium.

The subject device and secondary predicate device contain 1g gentamicin sulfate, on the contrary primary predicate device contains 0.5g gentamicin sulfate. Gentamicin sulfate is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens. As per gentamicin sulfate ratio is higher than the primary predicate device antibacterial efficacy can be considered as substantially equivalent to primary predicate device. Antibacterial efficacy tests are performed to subject device. On the other hand, release ratio of Gentamicin is important both in dosage and total release duration. OGM® 1A is subjected to Gentamicin release test comparatively with the predicate device. Lastly, gentamicin has a negative effect on product mechanical and physical properties. ISO 5833 tests are applied to OGM® 1A and demonstrated compliance.

Chemical formulas between predicate devices and subject device have slight differences. The primary predicate device contains chlorophyll additive serves as marking of the bone cement at the site of the operation. The subject device and secondary predicate device do not contain chlorophyll, but it is still visible as off white instead of green which chlorophyll provides for primary predicate device. Subject device has been carried out the ISO 5833 performance tests and ISO 10993 biocompatibility tests. ISO 5833 requirements are fulfilled. ISO 10993 test results demonstrates biological safety.

Endotoxin testing was performed to OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device).

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Image /page/13/Picture/0 description: The image shows the logo for ORMED GRUP MEDIKAL TUR.SAG.HIZ.SAN.VE.TIC.LTD.STI. The logo features the letters "OCM" in a stylized font, with the "O" and "C" in blue and the "M" in black. Below the letters is the company name in smaller, all-caps letters. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and other branding materials.

Conclusion

The non-clinical tests comply with the requirement of ISO 5833 and ASTM F451. Biological safety has been demonstrated according to the ISO 10993-1. Side-by-side mechanical tests were also performed according to ASTM D732, ASTM F2118 standards and the results are similar when compared to predicate devices. Endotoxin testing was performed to OGM® 1 and OGM® 1A according to USP Endotoxin Reference Standard. The results meet the limit value (20 EU/device). Antibacterial efficiency testing was performed according to the AATC and it is showed that the device is efficient to the E.Coli. Gentamicin release profile is also tested side-by-side with predicate device and the results are similar when compared to predicate devices (K023103). The differences between the predicate devices and the subject device do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”