OrthoSteady G Bone Cement

K173494 · G21, S.R.L. · LOD · Mar 6, 2018 · Orthopedic

Device Facts

• Record ID: K173494
• Device Name: OrthoSteady G Bone Cement
• Applicant: G21, S.R.L.
• Product Code: LOD · Orthopedic
• Decision Date: Mar 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OrthoSteady G Bone Cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Story

OrthoSteady G Bone Cement is a two-component PMMA (polymethylmethacrylate) bone cement containing Gentamicin sulphate antibiotic. It is used by orthopedic surgeons in clinical settings during the second stage of two-stage revision total joint arthroplasty. The device consists of separate sterile liquid and powder components that are mixed to form the cement. It functions as a fixation material for prosthetic implants. The device provides mechanical stability and local antibiotic delivery to the surgical site, aiding in the reconstruction of the joint after infection clearance. It is intended for prescription use only.

Clinical Evidence

Bench testing only. Performance testing included compressive strength, bending strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage. Results demonstrate performance comparable to predicate devices and compliance with ASTM F451-08, ISO 5833:2002, ASTM F2118-14, ASTM D2990-09, ASTM D638-14, and ASTM E399-12. Biocompatibility testing was conducted per ISO 10993 standards.

Technological Characteristics

Two-component PMMA bone cement containing Gentamicin sulphate. Materials comply with ISO 10993. Sterilization via ethylene oxide, gamma irradiation, and membrane filtration per ISO 11135, ISO 11138, ISO 10993-7, ISO 14161, ISO 14937, ISO 11737, and ISO 13408. Mechanical properties validated per ASTM F451-08, ISO 5833:2002, ASTM F2118-14, ASTM D2990-09, ASTM D638-14, and ASTM E399-12.

Indications for Use

Indicated for patients undergoing the second stage of a two-stage revision for total joint arthroplasty following the clearance of an initial infection.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• PALACOS R+G Bone Cement (K031673)
• DePuy CMWTM 1 Gentamicin Bone Cement (K053002)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 6, 2018

G21 s.r.l. % Mr. Barry E. Sands President ROMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K173494

Trade/Device Name: OrthoSteady G Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB Dated: January 29, 2018 Received: February 1, 2018

Dear Mr. Sands:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ronald P. Jean -S

- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173494

Device Name OrthoSteady G Bone Cement

Indications for Use (Describe)

OrthoSteady G Bone Cement 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)

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# 510(k) SUMMARY

# G21 s.r.l.

# OrthoSteady G Bone Cement

# 1. General Information

| Submitter: | G21 srl<br>via S. Pertini, 8<br>41039 San Possidonio (MO)- ITAL<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------|
| Official contact: | Barry E. Sands<br>Phone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | January 29, 2018 |
| Device | |
| Device Name: | OrthoSteady G Bone Cement |
| Common name: | Bone Cement, Antibiotic |
| Classification name: | 888.3027 - PMMA bone cement |
| Classification number: | Class II |

LOD MBB

### 3. Predicate Devices

Product Code:

2.

Primary PALACOS R+G Bone Cement device (Heraeus Kulzer GMBH & Co. KG) – K031673

Additional DePuy CMWTM 1 Gentamicin Bone Cement (DePuy Orthopaedics) - K053002

# 4. Indications for use/Intended Use

Indication for Use:

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OrthoSteady G Bone Cement is indicated for use in the second stage of a two stage revision for total ioint arthroplasty after the initial infection has been cleared.

#### 5. Summary of the technological characteristics of the subject devices compared to the predicate

The OrthoSteady G Bone Cement consists of Gentamicin sulphate antibiotic and a two component system consisting of separate, sterile and liquid powder components. All the materials (including the liquid and powder components) are within the range and covered by the predicate device.

#### 6. Biocompatibility

According to its categorization and ISO 10993 – 1 recommendations, biological effects that have been considered as per categorization of G1A and then suitable for OrthoSteady G include cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogen, AMES, LAL, and bone implantation toxicity and effects.

As recommended by the FDA's Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing', the subject devices and predicates comply with ISO 10993 at parts -3, -5, -6, -10, -11.

# 7. Sterilization

The sterilization process, including both the ethylene oxide method (packaged, aseptically processed, filled glass vials), gamma irradiation (packaged powder), and the membrane filter-sterilization (liguid component), has been validated and the sterility of the subject devices has been verified according to ISO 11135:2014, ISO 11138-1:2006, ISO 10993-7:2009, ISO 14161:2009, ISO 14937:2009, ISO 11737-1:2006, ISO 11737-2:2009, ISO 13408-1:2008, and ISO 13408-2:2003.

# 8. Performance data

Performance testing of compressive strength, bending strength, bending modulus, cyclic fatigue, tensile properties, creep, fracture toughness, and shrinkage was conducted to characterize OrthoSteady G Bone Cement as compared to the predicate, according to the FDA's Guide "Class II Special Controls Guidance Document: polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA".

Results show comparable performances to the predicate devices, and are in compliance with ASTM F451-08, ISO 5833:2002, ASTM F2118-14, ASTM D2990-09, ASTM D638- 14, and ASTM E399-12.

# 9. Conclusion and SE Determination

The OrthoSteady G Bone Cement is as safe and effective as the PALACOS R+G Bone Cement device (Heraeus Kulzer GMBH & Co. KG). The OrthoSteady G Bone Cement has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the OrthoSteady G Bone Cement and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrates that the OrthoSteady G

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Bone Cement is as safe and effective as the PALACOS R+G Bone Cement device (Heraeus Kulzer GMBH & Co. KG). The OrthoSteady G Bone Cement is substantially equivalent to the predicate devices.