K Number
K142148
Device Name
ORTHOHELIX STAPLE SYSTEM
Date Cleared
2014-08-21

(16 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.
Device Description
The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.
More Information

Not Found

No
The summary describes a mechanical staple system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Yes
The device is described as "fixation in the hand and foot including fractures, fusions, and osteotomies," indicating it is used to treat medical conditions.

No

The device is a system of staples used for fixation in the hand and foot, which is a therapeutic rather than a diagnostic function.

No

The device description explicitly states it consists of "various sizes of staples" which are physical implantable devices made of nickel titanium alloy. This is hardware, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "fixation in the hand and foot including fractures, fusions, and osteotomies." This describes a surgical implant used to stabilize bones, not a test performed on samples taken from the body to diagnose a condition.
  • Device Description: The device is described as "various sizes of staples used for fixation in the hand and foot." This further confirms it's a physical implant.
  • Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

N/A

Intended Use / Indications for Use

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

Product codes

JDR

Device Description

The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand and foot

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)

Engineering calculations, finite element analysis, mechanical bending and pullout tests per ASTM F564, and corrosion testing per ASTMF2129 were performed to demonstrate substantial equivalence of the subject to the predicate devices. No new issues of safety and effectiveness have been raised.

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

Not Found

Predicate Device(s)

K130832, K070031, K993714

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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

0

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

August 21, 2014

OrthoHelix Surgical Designs, Inc. Mr. Brian Hockett Director of Engineering - Lower Extremity 1065 Medina Road, Suite 500 Medina, Ohio 44256

Re: K142148 Trade/Device Name: OrthoHelix™ Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: July 16, 2014 Received: August 7, 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 (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 (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

510(k) Number (if known): K142148

Device Name: OrthoHelix™ Staple System

Indications for Use:

The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

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 ANOTHER PAGE OF NEEDED)

AND/OR

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:Liz Altenau
Contact Person:Brian Hockett or Liz Altenau
Date Prepared:7/16/14
Device Information
Trade Name:OrthoHelix™ Staple System
Common Name:Bone Staple

Classification Name: Staple, Fixation, Bone

Device Classification:

Single/multiple component metallic bone fixation appliances and accessories Class II per 21 CFR 888.3030 Panel: Orthopedic, Product Code: JDR

Material Composition: Nickel Titanium Alloy

  • Device Description: The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.
    The OrthoHelix™ Staple System is indicated for fixation in the hand and foot Intended Use: including fractures, fusions, and osteotomies.

Substantial Equivalence: The new OrthoHelix staples are substantially equivalent to the existing Orthohelix Staple System (K130832), the Stryker (Memometal Technologies) EasyClip Staple (K070031), and the BioMedical Enterprises Inc. Speed Staple (K993714). This submission is a modification to the OrthoHelix Staple System to add new staple sizes. The OrthoHelix Staple System conforms to ASTM F2063 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. Engineering calculations, finite element analysis, mechanical bending and pullout tests per ASTM F564, and corrosion testing per ASTMF2129 were performed to demonstrate substantial equivalence of the subject to the predicate devices. No new issues of safety and effectiveness have been raised.