Breakaway Screw System

K172886 · Paragon 28 · HRS · Dec 20, 2017 · Orthopedic

Device Facts

• Record ID: K172886
• Device Name: Breakaway Screw System
• Applicant: Paragon 28
• Product Code: HRS · Orthopedic
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures, revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used at ic patients. In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

Device Story

Breakaway Screw System consists of metallic bone fixation implants (plates, screws, washers) for lower extremity orthopedic procedures. Implants are used by surgeons in clinical settings to stabilize fractures, perform osteotomies, or achieve joint fusion in small bones of the foot and ankle. The system includes mini and standard size sets with locking and non-locking screw options. Surgeons select appropriate hardware based on anatomical requirements to provide mechanical fixation. The device functions as a structural support to maintain bone alignment during the healing process, facilitating bone reconstruction and arthrodesis. The system is intended for both adult and pediatric populations.

Clinical Evidence

Bench testing only. Engineering analysis provided to demonstrate that modified screw geometry maintains performance characteristics equivalent to the predicate device.

Technological Characteristics

Materials: medical grade titanium (ASTM F67), stainless steel (ASTM F138), titanium alloy (ASTM F136). Components: bone plates, locking/non-locking screws, washers. Design: mini and standard sets. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for stabilization and fixation of fractures or osteotomies, including intra/extra articular, joint depression, and multi-fragmentary fractures, revision procedures, joint fusion, and reconstruction of small bones of toes, feet, and ankles (distal tibia, talus, calcaneus) in adult and pediatric patients. Non-locking titanium screws/washers indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, and fracture repair.

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

• Gorilla Plating System (K140397)

Submission Summary (Full Text)

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December 20, 2017 Paragon 28 Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E Ste 280 Englewood, Colorado 80112

Re: K172886

Trade/Device Name: Breakaway Screw 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, HTN Dated: November 3, 2017 Received: November 14, 2017

Dear Eric Lintula:

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 (QS) regulation (21 CFR Part 820);

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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,

# 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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# Indications for Use

510(k) Number (if known)

#### K172886

Device Name Breakaway Screw System

#### Indications for Use (Describe)

The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures, revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used at ic patients.

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

| 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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## Section 8: 510(k) Summary

| Date: | 9/18/17 |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Paragon 28, Inc.<br>4B Inverness Ct. E., STE 280<br>Englewood, Colorado 80112<br>Phone: [phone]<br>Fax: [phone] |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Names: | Breakaway Screw System |
| Regulatory Class: | Class II |
| Regulation, Product<br>Code, Classification, and<br>Common Name: | 888.3030, HRS, Single/multiple component metallic<br>bone fixation appliances and accessories, bone plate<br>system<br><br>888.3040, HWC, Smooth or threaded metallic bone<br>fixation fastener, bone screw<br><br>888.3030, HTN, Single/multiple component metallic<br>bone fixation accessories, washer |
| Device Description: | The BABY GORILLA®/GORILLA® implants are<br>lower extremity fixation systems. Gorilla Plates are<br>offered in "mini" and "standard" set sizes in a variety of<br>shapes based upon the anatomical fixation required.<br>Screws are also offered in "mini" and "standard" sets<br>and, in addition, in locking and non-locking versions.<br>Size-matched washers are available for use with the non-<br>locking screws when the latter are used for fixation<br>without the plates. |
| Materials: | The BABY GORILLA®/GORILLA® implants are<br>manufactured from medical grade titanium (per ASTM<br>F67), stainless steel (per ASTM F138), and titanium<br>alloy (per ASTM F136). |
| Indications for Use: | The BABY GORILLA®/GORILLA® Bone Plates and<br>Bone Screws of the BABY GORILLA®/GORILLA®<br>Plating System are indicated for use in stabilization and<br>fixation of fractures or osteotomies; intra and extra<br>articular fractures, joint depression, and multi-<br>fragmentary fractures; revision procedures, joint fusion<br>and reconstruction of small bones of the toes, feet and<br>ankles including the distal tibia, talus, and calcaneus. The<br>system can be used in both adult and pediatric patients.<br><br>In addition, the non-locking, titanium screws and<br>washers are indicated for use in bone reconstruction |
| | osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device |
| Primary Predicate: | K140397, Gorilla Plating System (formerly Paralock Plating System) |
| Performance Data: | Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the modified screw geometry.<br>The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device. |
| Technological Characteristics: | The modified Gorilla screw possesses the same technological characteristics as the predicate devices. These include:<br>• performance,<br>• basic design,<br>• material, manufacturing and<br>• sizes (dimensions are comparable to those offered by the predicate systems).<br>Therefore, the fundamental scientific technology of the modified Gorilla Screw is similar to previously cleared devices. |
| Conclusion: | The modified Gorilla Screw possesses indications for use and technological characteristics the same as the predicate device. Therefore, the modified Gorilla Screw is substantially equivalent to the predicate. |

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