Cannulated Screw

K161058 · Miami Device Solutions, LLC · HWC · Jul 29, 2016 · Orthopedic

Device Facts

• Record ID: K161058
• Device Name: Cannulated Screw
• Applicant: Miami Device Solutions, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jul 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

Device Story

Cannulated bone screw; 3.5 mm diameter; 30-60 mm length. Used as line extension for MDS Proximal Humerus Plating System (K141493). Enables K-wire guided screw placement during orthopedic surgery. Surgeon inserts screw into bone to stabilize proximal humerus fractures. Device interfaces with existing MDS plates and locking caps. Single-use; supplied non-sterile.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F543 standard. Evaluated torsional strength, torque-out, and axial pull-out strength. Results demonstrated performance properties similar to predicate Zimmer and Arthrex devices, raising no new safety or effectiveness concerns.

Technological Characteristics

Material: Ti-6Al-4V ELI alloy (ASTM F136). Design: Fully threaded, polyaxial, cannulated bone screw. Dimensions: 3.5 mm diameter; 30-60 mm length (3 mm increments). Sterilization: Not sterile (single-use).

Indications for Use

Indicated for internal fixation of fractures of the proximal humerus in patients requiring surgical stabilization.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Miami Device Solutions, LLC Proximal Humerus Plating System (K141493)
• Arthrex Inc., Arthrex Humeral Fracture Plates & Screws (K041965)
• Zimmer, Inc. Proximal Humeral Plating System (K040593, K042598, K043227, K043560, K050121, K051098)

Reference Devices

• Paragon 28, Inc.; the Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments (K151418)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

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

July 29, 2016

Miami Device Solutions. LLC % Robert Poggie, Ph.D. President Biovera Incorporated 65 Promenade Saint Louis Notre-dame-de-l'ile-perrot. OC J7V7P2 Canada

Re: K161058

Trade/Device Name: Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: June 13, 2016 Received: June 15, 2016

Dear Dr. Poggie:

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

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Page 2 - Dr. Robert Poggie

with all the Act's 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); 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.

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/ResourcesforYou/Industry/default.htm. 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.

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 vours.

# Vincent J. Devlin -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K161058

Device Name

Cannulated Screw

Indications for Use (Describe)

The Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY

## Line Extension - Cannulated Screw for the Proximal Humerus Plating System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of the Cannulated Screw.

# A. SUBMITTERS INFORMATION, DEVICE IDENTIFICATION, AND MANUFACTURER

| Name: | Miami Device Solutions, LLC |
|-----------------------|---------------------------------------------------|
| Address: | 7620 NW 25th Street, Unit 3, Miami, FL 33122, USA |
| Registration Number: | 3009222247 |
| Contact Name: | Markku Biedermann |
| Title: | President |
| Device Trade Name: | Cannulated Screw |
| Device Common Name: | Bone screw |
| Classification Name: | Plate, fixation, bone; and Screw, fixation, bone |
| Classification Codes: | HWC and HRS - Class II |
| Classification Panel: | Orthopedic |
| Requlation Number: | 21 CFR section 888.3040 and 888.3030 |

## B. CORRESPONDENT INFORMATION

| Name: | BioVera, Inc. |
|---------------------|----------------------------------------------------------------------------------|
| Address: | 65 Promenade Saint-Louis, Notre-Dame-De-L'Ile-Perrot, Québec,<br>J7V 7P2, CANADA |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | [phone]; [phone] |
| Fax Number: | [phone] |
| Date of Submission: | July 28, 2016 |

### C.1. PREDICATE DEVICES

| K141493 | Miami Device Solutions, LLC Proximal Humerus Plating System |
|------------------------------------------------------------|-------------------------------------------------------------|
| K041965 | Arthrex Inc., Arthrex Humeral Fracture Plates & Screws |
| K040593, K042598,<br>K043227, K043560,<br>K050121, K051098 | Zimmer, Inc. Proximal Humeral Plating System |

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## C.2. REFERENCE DEVICES

K151418 Paragon 28, Inc.; the Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments

# D. DEVICE DESCRIPTION

The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.

Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.

# E. INTENDED USE

The Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

# F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The subject device is a titanium alloy, fully threaded, polyaxial, cannulated bone screw for use with the MDS Proximal Humerus Plating System. It is available in one diameter, 3.5 mm, and length options of 30 to 60 mm in 3 mm increments, and can be used with MDS plates and locking caps cleared in K141493. The subject Cannulated Screw is a line extension to the cleared MDS Proximal Humerus Plating System for the purpose of providing surgeons the option to guide the screw with a K-wire.

The material (Ti-6Al-4V ELI), indications for use, diameter, drive-interface detail, and polyaxial cone of angulation of the subject Cannulated Screw are identical to MDS noncannulated screws cleared in K141493 for the MDS Proximal Humerus Plating System. Performance testing of the MDS and Zimmer devices per ASTM F543 showed the subject cannulated screw to possess similar strength and performance characteristics as the predicate Zimmer cannulated screw, and the Arthrex predicate device (K041965). The MDS Cannulated Screw was determined to be substantially equivalent to the Zimmer and Arthrex predicate devices.

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# G. PERFORMANCE DATA

Characterization of the subject MDS Cannulated Screw and Predicate Zimmer Cannulated Screw was performed per consensus standard ASTM F543. More specifically, the subject MDS and predicate Zimmer cannulated screws were evaluated for torsional strength, torque-out, and axial pull out strength. The results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling.

The results of the performance testing per ASTM F543 indicate the MDS Cannulated Screw to be substantially equivalent to the predicate Zimmer cannulated screw and the predicate Arthrex screw, and to be safe when used per the products labeling and intended use.

# H. CONCLUSION

The Miami Device Solutions Cannulated Screw is substantially equivalent to the predicate devices cited in this 510(k) application.