K Number
K141004
Device Name
INTRAOSSEOUS FIXATION SYSTEM
Date Cleared
2014-08-21

(125 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.
Device Description
The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.
More Information

Not Found

No
The summary describes a mechanical fixation system and does not mention any software, algorithms, or AI/ML capabilities.

Yes
The device is described as assisting in the "fixation of fractures, fusions, and osteotomies," which are medical conditions, and its function involves stabilizing these conditions, directly aiming to treat or alleviate problems in the human body.

No
The device is described as an "Intraosseous Fixation System" intended to "stabilize and aid in fixation of fractures, fusions, and osteotomies." This indicates a therapeutic or supportive function rather than a diagnostic one.

No

The device description explicitly states that the system consists of "various size implants" manufactured from "implant grade titanium alloy or PEEK," which are physical hardware components.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • Device Description and Intended Use: The provided information clearly states that the Intraosseous Fixation System is used to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges. This is a surgical implant used directly within the body to treat a physical condition.
  • Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information.

Therefore, based on the provided description, the Intraosseous Fixation System is a surgical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

HTY

Device Description

The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy or PEEK.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

phalanges

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Mechanical 4 point bend, axial pull-out, insertion and removal torque and torque to failure testing were performed to establish substantial equivalence. No new issues of safety and effectiveness have been raised.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120165, K070598, K100618, K133636, K061164, K050259

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with the head tilted upwards.

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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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)

Page 1 of 1_

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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)
Panel: Orthopedic, Product Code: HTY
Material Composition:Titanium Alloy and Polyetheretherketone (PEEK)
Device Description:The Intraosseous Fixation System consists of various size implants to
stabilize and aid in the fixation of fracture, fusions, and osteotomies of
the phalanges. The implants are offered in different lengths and
diameters. All implants are manufactured from implant grade
titanium alloy or PEEK.
Intended Use:The Intraosseous Fixation System is intended to stabilize and aid in the
fixation of fractures, fusions, and osteotomies of phalanges.
Substantial Equivalence:The Intraosseous Fixation System is substantially equivalent to the
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)
and Arthrex Bio-Pin (K050259). Mechanical 4 point bend, axial pull-
out, insertion and removal torque and torque to failure testing were
performed to establish substantial equivalence. No new issues of
safety and effectiveness have been raised.