INTRAOSSEOUS FIXATION SYSTEM

K141004 · Orthohelix Surgical Designs, Inc. · HTY · Aug 21, 2014 · Orthopedic

Device Facts

• Record ID: K141004
• Device Name: INTRAOSSEOUS FIXATION SYSTEM
• Applicant: Orthohelix Surgical Designs, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Aug 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intraosseous Fixation System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of phalanges.

Device Story

Intraosseous Fixation System consists of various sized implants (titanium alloy or PEEK) used to stabilize and fixate phalangeal fractures, fusions, and osteotomies. Device is used by surgeons in clinical settings. Implants are inserted into bone to provide mechanical stability during healing. Output is the physical stabilization of bone segments. Benefit is improved bone alignment and fixation.

Clinical Evidence

Bench testing only. Mechanical testing performed included 4-point bend, axial pull-out, insertion and removal torque, and torque to failure testing to establish substantial equivalence.

Technological Characteristics

Materials: Titanium alloy and Polyetheretherketone (PEEK). Form factor: Various lengths and diameters of implants for intraosseous fixation. Principle: Mechanical bone fixation fastener. No software or energy source.

Indications for Use

Indicated for stabilization and fixation of fractures, fusions, and osteotomies of the phalanges.

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

• OrthoHelix Intraosseous Fixation System (K120165)
• MMI Smart Toe (K070598)
• OrthoHelix MaxLock Extreme Extremity Plating System with Variable Angle Technology (K100618)
• Extremity Medical HammerFiX IP Fusion System (K133636)
• Bioretec ActivaPin (K061164)
• Arthrex Bio-Pin (K050259)

Submission Summary (Full Text)

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

August 21, 2014

Tornier, OrthoHelix Surgical Designs, Inc. Mr. Brian Hockett Director of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K141004

Trade/Device Name: Intraosseous Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: August 4, 2014 Received: August 6, 2014

Dear Mr. Brian Hockett:

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

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Page 2 - Mr. Brian Hockett

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

# Lori A. Wiggins -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

K141004 510(k) Number TBD:

Device Name: Intraosseous Fixation System

Indications for Use:

The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) SUMMARY

### Submitter Information

| Submitter's Name: | OrthoHelix Surgical Designs, Inc. |
|-------------------|-----------------------------------|
| Address: | 1065 Medina Rd, Suite 500 |
| | Medina, Ohio 44256 |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Amanda Martin and Simon Sjovold |
| Contact Person: | Brian Hockett |
| Date Prepared: | 8/20/2014 |

### Device Information

| Trade Name: | Intraosseous Fixation System |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Fixation Device |
| Classification Name: | Pin, Fixation, Smooth |
| Device Classification: | Pin, Fixation, Smooth (Class II per 21 CFR 888.3040)<br>Panel: Orthopedic, Product Code: HTY |
| Material Composition: | Titanium Alloy and Polyetheretherketone (PEEK) |
| Device Description: | The Intraosseous Fixation System consists of various size implants to<br>stabilize and aid in the fixation of fracture, fusions, and osteotomies of<br>the phalanges. The implants are offered in different lengths and<br>diameters. All implants are manufactured from implant grade<br>titanium alloy or PEEK. |
| Intended Use: | The Intraosseous Fixation System is intended to stabilize and aid in the<br>fixation of fractures, fusions, and osteotomies of phalanges. |
| Substantial Equivalence: | The Intraosseous Fixation System is substantially equivalent to the<br>OrthoHelix Intraosseous Fixation System (K120165), MMI Smart Toe<br>(K070598), OrthoHelix MaxLock Extreme Extremity Plating System<br>with Variable Angle Technology (K100618), Extremity Medical<br>HammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164)<br>and Arthrex Bio-Pin (K050259). Mechanical 4 point bend, axial pull-<br>out, insertion and removal torque and torque to failure testing were<br>performed to establish substantial equivalence. No new issues of<br>safety and effectiveness have been raised. |