K Number
K133523
Device Name
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
Manufacturer
Date Cleared
2014-02-06

(83 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet.
Device Description
The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm.
More Information

Not Found

No
The summary describes a mechanical implant made of superelastic material and its intended use and performance testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.

No
The device is a bone staple used in surgical procedures for bones and joints, which is an implantable medical device, not a therapeutic device designed for therapy or treatment delivery.

No.
The device is described as an implant used for treating bone fractures, osteotomies, and arthrodesis, not for diagnosing medical conditions.

No

The device description clearly states it is comprised of "superelastic bone staples" made of Nitinol, which are physical implants. This is a hardware device, 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 "osteotomy and arthrodesis of bones and joints of the hands and feet." This describes a surgical procedure performed directly on the patient's body.
  • Device Description: The device is a "Superelastic Implant Bone Staples" made of Nitinol. This is a physical implant used to stabilize bones.
  • Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.

The device is a surgical implant used for treatment, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

"The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet ."

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

JDR

Device Description

"The Instratek STAPIX™ Superelastic Implant Bone Staples kits are comprised of superelastic bone staples in 16 configurations. The Nitinol staples have a finished A(f) temperature of 10°C +/7° to ensure that the material is superelastic at room and body temperatures. The Instratek STAPIX™ Superelastic Implant is indicated for use in the treatment of bone fractures, osteotomies, and arthrodesis for the reconstructive surgeon. The device is intended for hand and foot surgery. STAPIX™ bone staples are made from superelastic nickel titanium that does not require cold storage or heating. Implant sizes range from 9mm to 24mm."

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bones and joints of the hands and feet

Indicated Patient Age Range

Not Found

Intended User / Care Setting

reconstructive surgeon

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)

"Performance testing consisted of bending fatigue, static bending, and corrosion."

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.

K070031, K122113, K051408

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

§ 888.3030 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

:

510(K) SUMMARY K133523

| Submission Correspondent
and Owner: | Instratek, Inc.
15200 Middlebrook Dr., Suite G
Houston, TX 77058
USA |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
President |
| Date summary prepared: | February 4, 2014 |
| Device trade name: | STAPIX™ Superelastic Implant Bone Staples |
| Device common name: | Bone Staple |
| Device classification name: | Staple, Fixation, Bone
JDR at 21 CFR Part 880.3030 |
| Legally marketed device to
which the device is
substantially equivalent: | Memometal Easyclip Cleared March 19, 2007 under K070031
Memory Metal Staples, Easyclip Cleared March 12, 2013 under
K122113
InteliFUSE, cleared June 29, 2005 under K051408 |
| Description of the device: | The Instratek STAPIX™ Superelastic Implant Bone Staples kits are
comprised of superelastic bone staples in 16 configurations. The
Nitinol staples have a finished A(f) temperature of 10°C +/7° to
ensure that the material is superelastic at room and body
temperatures. The Instratek STAPIX™ Superelastic Implant is
indicated for use in the treatment of bone fractures, osteotomies,
and arthrodesis for the reconstructive surgeon. The device is
intended for hand and foot surgery. STAPIX™ bone staples are
made from superelastic nickel titanium that does not require cold
storage or heating. Implant sizes range from 9mm to 24mm. |
| Intended use of the device: | The Instratek STAPIX™ Superelastic Implant is indicated for use in
osteotomy and arthrodesis of bones and joints of the hands and feet. |
| Technological
characteristics: | The proposed device has the same technological characteristics as
the predicate devices. |
| Testing: | Performance testing consisted of bending fatigue, static bending,
and corrosion. |
| Conclusions: | The results of the comparison of design, materials, intended use and
technological characteristics demonstrate that the device is as safe
and effective as the legally marketed predicate devices. |

.

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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, with three curved lines representing its wings.

Public Health Service

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

February 6, 2014

Instratek, Incorporated Mr. Jeff Seavey President 15200 Middlebrook, Suite G Houston, Texas 77058

Re: K133523

Trade/Device Name: STAPIX™ Superelastic Implant Bone Staples 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: December 12, 2013 Received: December 13, 2013

Dear Mr. Seavey:

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

2

Page 2 - Mr. Jeff Seavey

device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Vincen制动Devlin -S

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

3

INDICATIONS FOR USE STATEMENT

510(k) Number:

K133523

Device Name:

STAPIX™ Superelastic Implant Bone Staples

Indications for Use:

The Instratek STAPIX™ Superelastic Implant is indicated for use in osteotomy and arthrodesis of bones and joints of the hands and feet .

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices