CurvaFix Intramedullary Rodscrew System

K180050 · Curvafix, Inc. · HWC · Mar 1, 2019 · Orthopedic

Device Facts

• Record ID: K180050
• Device Name: CurvaFix Intramedullary Rodscrew System
• Applicant: Curvafix, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.

Device Story

Flexible intramedullary device for pelvic fracture fixation; features threaded, self-tapping distal end and proximal driving torque interface. Integral shape-lock mechanism transitions device from flexible to rigid state post-implantation; reversible to flexible state for explantation. Available in single diameter with various lengths. Used by orthopedic surgeons in clinical settings for bone stabilization. Benefits include improved fixation capability in curved pelvic anatomy compared to traditional rigid screws.

Clinical Evidence

Bench testing only. Mechanical performance evaluated per ASTM F543 and ASTM F1264 standards using worst-case device configurations. Results demonstrate substantial equivalence to predicate.

Technological Characteristics

Stainless steel (316 LVM per ASTM F138). Threaded, self-tapping distal end. Integral shape-lock mechanism for flexible-to-rigid transition. Dimensions: single diameter, various lengths. Mechanical testing per ASTM F543 and ASTM F1264.

Indications for Use

Indicated for fixation of pelvic fractures in patients requiring metallic bone fixation fasteners.

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

• 3.5 mm Pelvic Cortex Screws (Synthes Inc. - K043185)

Submission Summary (Full Text)

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March 1, 2019

CurvaFix, Inc. % Karen Warden President BackRoads Consulting Po Box 566 Chesterland, Ohio 44026-0566

Re: K180050

Trade/Device Name: CurvaFix Intramedullary Rodscrew System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC. HSB Dated: February 22, 2019 Received: February 25, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Vesa
Vuniqi -S
Digitally signed
by Vesa Vuniqi -S
Date: 2019.03.01
17:03:12 -05'00'

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

Form Approved: OMB No. 0910-0120 Expiration Date: 6/30/2020 See PRA Statement below.

510(k) Number (if known) K180050

#### Device Name

CurvaFix® Intramedullary Rodscrew System

#### Indications for Use (Describe)

The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures of the pelvis.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

| Date: | 4 January 2018 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | CurvaFix, Inc. |
| | 1000 124th Ave NE, Suite 100 |
| | Bellevue WA 98005 |
| | Curvafix.com |
| Sponsor Contact: | Steve Dimmer, CEO |
| 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc. |
| | PO Box 566 |
| | Chesterland, OH 44026 |
| | Office: 440.729.8457 |
| Proposed Trade Name: | CurvaFix® Intramedullary Rodscrew System |
| Common Name: | Bone screw |
| Device Classification: | Class II |
| Regulation Name,<br>Regulation Number,<br>Product Code: | Smooth or threaded metallic bone fixation fastener, 888.3040, HWC<br>Intramedullary fixation rod, 888.3020, HSB |
| Device Description: | The CurvaFix Intramedullary Rodscrew System is a collection of flexible<br>intramedullary devices for pelvic fracture fixation. The devices have a<br>threaded, self-tapping distal end and a driving torque interface at the<br>proximal end. An integral shape lock feature changes the Rodscrew from a<br>flexible to rigid state after implantation. The Rodscrew can be returned to a<br>flexible state should explantation be required. The implants are available in a<br>single diameter and an assortment of lengths to accommodate a variety of<br>anatomic requirements. |
| Indications for Use: | The CurvaFix® Intramedullary Rodscrew is intended for fixation of fractures<br>of the pelvis. |
| Materials: | The CurvaFix Intramedullary Rodscrew System implants are manufactured<br>from stainless steel (316 LVM per ASTM F138) . |
| Primary Predicate: | Primary: 3.5 mm Pelvic Cortex Screws (Synthes Inc. - K043185) |
| Performance Data: | Mechanical testing of worst case CurvaFix Intramedullary Rodscrew was<br>performed according to ASTM F543. Additional mechanical properties were<br>evaluated following ASTM F1264. The mechanical test results demonstrate<br>that CurvaFix Intramedullary Rodscrew performance is substantially<br>equivalent to the predicate. |
| Technological<br>Characteristics: | The CurvaFix Intramedullary Rodscrew System possesses the same<br>technological characteristics as one or more of the predicate devices. These<br>include: intended use (as described above), basic design (threaded fixation),<br>anatomic location (pelvis) and material (stainless steel).<br>Differences between the subject and predicate devices did not raise new<br>questions of safety and effectiveness. Therefore the fundamental scientific<br>technology of the CurvaFix® Intramedullary Rodscrew System is similar to<br>previously cleared devices. |
| Conclusion: | The CurvaFix Intramedullary Rodscrew System possesses the same<br>intended use and technological characteristics as the predicate devices.<br>Therefore CurvaFix Intramedullary Rodscrew System is substantially<br>equivalent for its intended use. |