Phantom Small Bone Intramedullary Nail System

K170693 · Paragon 28, Inc. · KTW · Jun 19, 2017 · Orthopedic

Device Facts

• Record ID: K170693
• Device Name: Phantom Small Bone Intramedullary Nail System
• Applicant: Paragon 28, Inc.
• Product Code: KTW · Orthopedic
• Decision Date: Jun 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

Device Story

System consists of intramedullary nails, locking screws, and threaded pegs; used for stabilization and fixation of small bones in feet and ankle. Implants inserted by surgeon during orthopedic procedures (fracture repair, joint fusion, reconstruction). Nails available in various lengths to accommodate patient anatomy; locking screws and pegs secure construct within bone. System includes dedicated implantation instruments. Provides mechanical stability to bone segments to facilitate healing. Used in clinical/surgical settings.

Clinical Evidence

Bench testing only. Static and dynamic bending tests performed per ASTM F382; torsion, insertion/removal, and pullout testing performed per ASTM F543. Results demonstrate mechanical performance equivalent to predicate.

Technological Characteristics

Implants manufactured from medical grade titanium alloy (ASTM F136). System includes intramedullary nails, locking screws, and threaded pegs. Mechanical performance validated per ASTM F382 and ASTM F543. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for stabilization and fixation of small bones of feet and ankle in patients requiring treatment for fractures, osteotomies, nonunions, pseudarthroses, and malunions via revision, joint fusion, or reconstruction.

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

• ParaLock Plating System (K140397)

Submission Summary (Full Text)

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June 19, 2017

Paragon 28, Inc. % Karen Warden Representative/Consultant BackRoads Consulting. Inc PO Box 566 Chesterland, Ohio 44026-0566

Re: K170693

Trade/Device Name: Phantom Small Bone Intramedullary Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTW, HWC Dated: March 6, 2017 Received: March 7, 2017

Dear Karen Warden:

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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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 (reporting of medical devicerelated 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,

# Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K170693

Device Name Phantom™ Small Bone Intramedullary Nail System

#### Indications for Use (Describe)

The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 6 March 2017 |
| Sponsor: | Paragon 28, Inc.<br>4B Inverness Ct. E., STE 280<br>Englewood, Colorado 80112<br>Phone: [phone], Facsimile: [phone] |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 |
| Trade Names: | PhantomTM Small Bone Intramedullary Nail System |
| Common Name: | Combination nail/plate |
| Regulatory Class: | Class II |
| Classification Name,<br>Regulation, Product<br>Code: | Appliance, fixation, nail/blade/plate combination, single component,<br>888.3030, KTW<br>Screw, Fixation, Bone, 888.3040, HWC |
| Device Description: | The PhantomTM Small Bone Intramedullary Nail System is comprised of<br>small bone intramedullary nails, locking screws and threaded pegs. The<br>PhantomTM nails are offered in a variety of lengths to accommodate<br>variations in patient anatomy. The PhantomTM threaded pegs and locking<br>screws insert through the intramedullary nail to secure the construct.<br>These are offered in varying lengths to accommodate the anatomical<br>fixation required. The system includes instruments for implantation. |
| Indications for Use: | The PhantomTM Small Bone Intramedullary Nail System is indicated for<br>use in stabilization and fixation of the small bones of the feet and ankle<br>for the treatment of fractures, osteotomies, nonunions, pseudarthroses<br>and malunions by revision, joint fusion or reconstruction procedures. |
| Materials: | The PhantomTM Small Bone Intramedullary Nail System implants are<br>manufactured from medical grade titanium alloy (per ASTM F136). |
| Primary Predicate: | ParaLock Plating SystemTM (Paragon 28, Inc. – K140397) |
| Performance Data: | Mechanical testing of the worst case PhantomTM nail included static and<br>dynamic bending performed according to ASTM F382. Mechanical testing<br>of the worst case PhantomTM locking screw and threaded peg included<br>torsion, insertion/removal and pullout performed according to ASTM<br>F543. The mechanical test results and predicate comparisons<br>demonstrated that the mechanical performance of the Small Bone<br>Intramedullary Nail System is substantially equivalent to the predicate. |
| Technological<br>Characteristics: | The PhantomTM Small Bone Intramedullary Nail System possesses<br>similar technological characteristics compared to the predicate device.<br>These include:<br>performance,basic design,material, manufacturing andsizes (dimensions are comparable to those offered by the<br>predicate systems).The difference in the stabilization method between the subject and<br>predicate devices, i.e., combination nail/plate versus plate, did not raise |
| | new questions of safety or effectiveness. Therefore the fundamental<br>scientific technology of the Phantom™ Small Bone Intramedullary Nail<br>System is substantially equivalent to previously cleared devices. |
| Conclusion: | The Phantom™ Small Bone Intramedullary Nail System possesses<br>indications for use and technological characteristics the same as and<br>similar to the predicate devices. Therefore the Phantom™ Small Bone<br>Intramedullary Nail System is substantially equivalent to the predicates. |

## 510(k) Summary

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