PROXIMAL HUMERUS PLATING SYSTEM

K141493 · Miami Device Solutions · HRS · Mar 20, 2015 · Orthopedic

Device Facts

• Record ID: K141493
• Device Name: PROXIMAL HUMERUS PLATING SYSTEM
• Applicant: Miami Device Solutions
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.

Device Story

The Proximal Humerus Plating System is an orthopedic internal fixation device consisting of metallic plates, screws, and locking caps. It is used by surgeons in an operating room setting to stabilize proximal humerus fractures. The device functions by providing mechanical support to the fractured bone, allowing for proper healing. The surgeon selects the appropriate plate length and screw size based on the patient's anatomy and fracture pattern. The system is implanted during surgery to provide rigid fixation, which helps restore bone alignment and stability, potentially improving patient recovery outcomes.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated via bench testing according to ASTM F382-99 (metallic bone plates) and ASTM F543-07 (metallic bone screws).

Technological Characteristics

Metallic bone fixation system consisting of plates, 3.5mm diameter screws, and locking caps. Materials and design tested per ASTM F382-99 and ASTM F543-07. Side-specific plates available in two lengths.

Indications for Use

Indicated for internal fixation of fractures of the proximal humerus.

Regulatory Classification

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.

Predicate Devices

• Arthrex Humeral Fracture Plates and Screws (K041965)
• Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735)
• Zimmer Universal Locking System, 3.5mm (K081759)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 20, 2015

Miami Device Solutions. LLC % Mr. Peter J. Mincieli HealthLink Associates, Incorporated 631 South East 11th Street Pompano Beach, Florida 33060

Re: K141493

Trade/Device Name: Proximal Humerus Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: December 23, 2014 Received: December 29, 2014

Dear Mr. Mincieli:

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

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Page 2 - Mr. Peter J. Mincieli

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -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

| 510(k) Number (if known) | K141493 |
|--------------------------|---------|
|--------------------------|---------|

Device Name: Proximal Humerus Plating System

The MDS Proximal Humerus Plating System is intended to provide internal fixation of fractures of the proximal humerus.

Prescription Use X (Per 21 CFR 801 Subpart D) and/or

Over the Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

| Name of Applicant: | Miami Device Solutions, LLC<br>Markku Biedermann<br>7620 NW 25th Street, Unit 3<br>Miami, FL 33122<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Healthlink Associates, Inc.<br>Peter J Mincieli<br>631 SE 11th Street<br>Pompano Beach, FL 33060<br>Phone: [phone]<br>Fax: [phone] |
| Date: | 02-19-2015 |
| Trade Name: | Proximal Humerus Plating System |
| Common Name: | Single/Multiple component metallic bone fixation appliances and accessories<br>Smooth or threaded metallic bone fixation fastener |
| Classification: | Class II per 21 CFR 888.3030 |
| Device Product Code: | HRS / HWC |
| Predicate Devices: | Arthrex Humeral Fracture Plates and Screws - K041965<br>Smith and Nephew Inc. Peri-Loc Locking Bone Plates and Locking Bone Screws for the<br>Upper -Extremity - K051735<br>Zimmer Universal Locking System, 3.5mm - K081759 |
| Device Description: | The Proximal Humerus Plating System is an internal fixation plate system to be used for<br>proximal humerus fractures. The system consists of plates, screws, and locking caps. Th<br>Proximal Humerus Plates are available in two lengths, and are side-specific.<br>The Proximal Humerus Plating System Screws are 3.5mm in diameter and available in<br>various lengths. |
| Intended Use: | The Proximal Humerus Plating System is indicated for internal fixation of fractures of<br>the proximal humerus. |
| Comparison to Predicate Device: | The Proximal Humerus Plating System has the same intended use, similar performance<br>characteristics, and is similar in design and materials to the predicate devices listed<br>above, with the exception of the Smith and Nephew Self-Tapping Locking Screw which |

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Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing demonstrate that the device is safe and effective.

Substantial equivalence was demonstrated in the performance testing section of the submission by comparing the design and testing according to ASTMF382-99, Standard Test Method for Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws which shows that the Proximal Humerus Plating System performs as well as the predicate devices. Comparison of the design, intended use, and testing demonstrate that the Proximal Humerus Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.