MDS Plating System

K172786 · Miami Device Solutions, LLC · HRS · Dec 8, 2017 · Orthopedic

Device Facts

• Record ID: K172786
• Device Name: MDS Plating System
• Applicant: Miami Device Solutions, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium. The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

Device Story

MDS Plating System is an internal bone fixation system consisting of straight and pre-contoured plates, screws, locking caps, and threaded cerclage buttons. Used by surgeons in clinical settings for fracture stabilization. Implants are single-use; system includes both single-use and reusable instruments. Device provides mechanical support to bone fragments to facilitate healing. Surgeon selects appropriate plate/screw configuration based on fracture site and patient anatomy. Benefits include stabilization of fractures and periprosthetic fractures, aiding bone union.

Clinical Evidence

No clinical data provided; substantial equivalence supported by non-clinical bench testing and engineering analysis.

Technological Characteristics

Materials: Titanium alloy and stainless steel. Components: Plates (straight/pre-contoured), screws, locking caps, threaded cerclage buttons. Testing standards: ASTM F382-99 (metallic bone plates) and ASTM F543-07 (metallic bone screws).

Indications for Use

Indicated for internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula, foot, and ankle, and for fixation of periprosthetic fractures.

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

• Acumed Small Fragment Base Set (K143394)
• Miami Device Solutions Distal Radius Plating System (K161292/K162635)
• Miami Device Solutions Proximal Humerus Plating System (K141493)
• Synthes Cerclage Positioning Pin (K992891)
• Variax 2 System Bone Screws (K132502/K140769)
• Miami Device Solutions Olecranon (K162898)

Reference Devices

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

Submission Summary (Full Text)

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December 8, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized caduceus symbol. To the right of it is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Miami Device Solutions, LLC Michelle Montesino Regulatory Affairs Associate 7620 NW 25th Street. Unit 3 Miami, Florida 33122

## Re: K172786

Trade/Device Name: MDS 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: September 14, 2017 Received: September 15, 2017

# Dear Michelle Montesino:

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 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.

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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 medical devices and radiation-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,

# Katherine D. Kavlock -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)

K172786

Device Name MDS Plating System

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

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> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) SUMMARY

| Submitter Name: | Miami Device Solutions, LLC | | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------|
| Submitter Address: | 7620 NW 25th Street, Unit 3;<br>Miami, FL 33122 | | |
| Contact Person: | Michelle Montesino<br>Phone: [phone] Ext. 106<br>Fax: [phone] | | |
| | Anderson Giraldo<br>Phone: [phone] Ext 115<br>Fax: [phone] | | |
| Date of Submission: | 9/14/2017 | | |
| Manufacturer Name: | Miami Device Solutions, LLC | | |
| Manufacturer Address: | 7620 NW 25th Street, Unit 3;<br>Miami, FL 33122 | | |
| Registration Number: | 3009222247 | | |
| Contact Name: | Markku Biedermann | | |
| Title: | President | | |
| Device Trade Name: | MDS Plating System | | |
| Device Common Name: | Primary: Plate, Fixation, Bone<br>Secondary: Screw, Fixation, Bone | | |
| Classification Names: | Primary: Plate, fixation, bone<br>Secondary: Screw, fixation, bone | | |
| Classification Code: | Primary: HRS – Class II<br>Secondary: HWC – Class II | | |
| Classification Panel: | Orthopedic | | |
| Regulation Number: | Primary: 21 CFR section 888.3030 – Single/multiple component<br>metallic bone fixation appliances and accessories | | |
| | Secondary: 21 CFR section 888.3040 – Smooth or threaded metallic<br>bone fixation fastener | | |
| Predicate Device: | Primary | K143394 | Acumed Small Fragment Base Set |
| | Secondary | K161292/<br>K162635 | Miami Device Solutions Distal<br>Radius Plating System |
| | | Plating System | |
| Secondary | K141493 | Miami Device Solutions Proximal<br>Humerus Plating System | |
| Secondary | K992891 | Synthes Cerclage Positioning Pin | |
| Secondary | K132502,<br>K140769 | Variax 2 System Bone Screws | |

Secondary

K162898

Miami Device Solutions Olecranon

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K172786

#### Reference Devices:

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

#### Device Description:

The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:

- Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
- -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
- Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
- Low Profile Head Screws -
- -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.

Additionally, the system includes single use and reusable instruments.

Materials: Titanium alloy and Stainless Steel.

#### Intended Use:

The MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

#### Substantial Equivalence Statement:

Documentation is provided which demonstrates that the MDS Plating System is equivalent to its predicate devices in terms of material, design, indications for use, and performance characteristics.

#### Performance Data:

#### Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicated designs, as well as 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. Comparison of the design, intended use, and testing demonstrate that the MDS Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.

#### Clinical Performance and Conclusions:

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Clinical data and conclusions were not needed for this device.

# Conclusion

The MDS Plating System is substantially equivalent to the predicate devices.