(337 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of bone cement, with no mention of AI or ML technologies.
Yes.
OGM® 1 is used for the fixation of prosthetic implants to living bone during arthroplastic procedures, providing a supportive function in a surgical context. OGM® 1A is used in revision surgery for total joint arthroplasty after infection clearance, with the added benefit of Gentamicin (an antibiotic), indicating a direct therapeutic purpose.
No.
The device is a bone cement used for fixing prosthetic implants. It is not designed to diagnose a condition or disease.
No
The device description clearly states that OGM® 1 and OGM® 1A are polymethylmethacrylate (PMMA) bone cements consisting of physical components (monomer liquid and polymer powder) and are intended for physical fixation of implants. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for fixing prosthetic implants to bone during surgery. This is a surgical procedure, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a bone cement, a material used in surgery. It's not designed to analyze a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used in vivo (within the body) during a surgical procedure, not in vitro (in glass/outside the body) for diagnostic testing.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB
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® 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® 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee and other joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Results:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
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
1
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
2
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."
3
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.
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."
4
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) |
| +90-532-397-3043 | |
| mformeci@gmail.com | |
| Fax Number: + 90 312 211 01 93 | |
| Summary Preparation Date | 03/28/2022 |
| Trade Or Proprietary
| Name | 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 Device
510k No | Primary Predicate Device Manufacturer |
|------------------------|-------------------------------------|--------------------------------------------------------------------------|
| OGM® 1
K211869 | PALACOS® R
K202475 | Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
61273 Wehrheim Germany |
| OGM® 1A
K211869 | PALACOS® R+G
K202475 | Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
61273 Wehrheim Germany |
| Subject Device 510k No | Seconder Predicate
Device 510k No | Primary Predicate Device Manufacturer |
|------------------------|----------------------------------------------|-------------------------------------------------------|
| OGM® 1A
K211869 | DePuy 1 Gentamicin Bone
Cement
K023103 | DePuy, Inc.
700 Orthopaedic Drive Warsaw, IN 46581 |
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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).
6
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).
8
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.
9
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 Device
K211869 | Predicate Device
K202475 | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Image: COGM | Image: Heraeus | |
| Device Name | OGM® 1 | Palacos® R | |
| Intended 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. | Palacos® R is indicated for use in
arthroplastic procedures of the hip, knee,
and other joints for the fixation of polymer or
metallic 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 Chemical
Composition | poly(methyl acrylate, methyl methacrylate)
35.6 g | poly(methyl acrylate, methyl methacrylate)
33.8 g | similar |
| | Barium sulfate
4 g | zirconium dioxide
5.9 g | similar |
| | hydrous benzoyl peroxide
0.4 g | hydrous benzoyl peroxide
0.3 g | similar |
| | | chlorophyll VIII trace amount | different |
| Liquid Chemical
Composition | methyl methacrylate
19.6 g | methyl methacrylate
18.4 g | similar |
| | N,N-dimethyl-p-toluidine
0.4 g | N,N-dimethyl-p-toluidine
0.4 g | Same |
| | | liquid: chlorophyll VIII in an oily solution
trace amount | different |
| | Hydroquinone trace amount | Hydroquinone trace amount | same |
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
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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).
11
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 Device
K211869 | Primary Predicate Device
K202475 | Secondary Predicate Device
K023103 | Primary
Comparison | Secondary
Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|-------------------------|
| Manufacturer | | Heraeus | | - | - |
| Device Name | OGM® 1A | Palacos® R+G | DePuy 1 Gentamicin Bone
Cement | - | - |
| Intended Use | 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. | Palacos® R+G is indicated for use in
the second stage of a two-stage
revision for total joint arthroplasty
after the initial infection has been
cleared. | DePuy 1 Gentamicin is indicated for
use in the second stage of a two
stage revision for total joint
arthroplasty after the initial
infection has been cleared. | same | same |
| Components | 40g powder (polymer) and 20ml
liquid (monomer) is individually
packed. | 40g powder (polymer) and 20ml
liquid (monomer) is individually
packed. | 40g powder (polymer) and 20ml
liquid (monomer) is individually
packed. | same | same |
| Sterilization | ethylene oxide and sterile
filtration | 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 Chemical
Composition | poly(methyl acrylate, methyl
methacrylate)
35.6 g | poly(methyl acrylate, methyl
methacrylate)
33.6 g | poly(methyl acrylate, methyl
methacrylate)
84.73 (%w/w) | similar | similar |
| | Barium sulfate
4 g | zirconium dioxide
6.1 g | Barium sulfate
9.10 (%w/w) | similar | similar |
| | hydrous benzoyl peroxide
0.4 g | hydrous benzoyl peroxide
0.3 g | hydrous benzoyl peroxide
1.95 (%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 Chemical
Composition | methyl methacrylate
19.6 g | methyl methacrylate
18.4 g | methyl methacrylate
98.50 (%w/w) | similar | similar |
| | N,N-dimethyl-p-toluidine
0.4 g | N,N-dimethyl-p-toluidine
0.4 g | N,N-dimethyl-p-toluidine