ITST Intertrochanteric/Subtrochanteric Fixation System

K143321 · Zimmer, Inc. · HSB · May 29, 2015 · Orthopedic

Device Facts

• Record ID: K143321
• Device Name: ITST Intertrochanteric/Subtrochanteric Fixation System
• Applicant: Zimmer, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as: Subtrochanteric Fractures, Intertrochanteric Fractures, Comminuted Fractures, Segmental Fractures, Fractures with Bone Loss, Proximal and Distal Fractures, and Nonunions

Device Story

ITST Intertrochanteric/Subtrochanteric Fixation System is a line extension for closed femoral nailing; system includes intramedullary nails, lag screws, anti-rotation screws, nail caps, and 4.5mm cortical screws. Cortical screws provide distal locking of the nail. Used by orthopedic surgeons in clinical settings to stabilize femoral fractures. Device provides mechanical fixation to facilitate bone healing. No software or AI components.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance data, including dimensional evaluation and biocompatibility testing per ISO 10993-1 and 21 CFR 58. Accelerated aging testing established a 10-year shelf life.

Technological Characteristics

Intramedullary fixation rod system. Components include femoral nails, lag screws, anti-rotation screws, and 4.5mm cortical screws. Materials are consistent with predicate M/DN system. Biocompatibility verified per ISO 10993-1. Mechanical fixation principle.

Indications for Use

Indicated for patients with femoral fractures including subtrochanteric, intertrochanteric, comminuted, segmental, proximal/distal fractures, fractures with bone loss, and nonunions.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• M/DN® Intramedullary Fixation (K142281)

Submission Summary (Full Text)

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May 29, 2015

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

Zimmer, Incorporated Mr. Stephen H. McKelvey Senior Project Manager, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K143321

Trade/Device Name: ITST® Intertrochanteric/Subtrochanteric Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 27, 2015 Received: April 29, 2015

Dear Mr. McKelvey:

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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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.

# Mark N. Melkerson -S

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

#### 510(k) Number (if known) K143321

#### Device Name

ITST® Intertrochanteric/Subtrochanteric Fixation System

Indications for Use (Describe)

The ITST Intramedullary Nail is indicated for use in a variety of femoral fractures, such as:

- · Subtrochanteric Fractures
- · Intertrochanteric Fractures
- Comminuted Fractures
- · Segmental Fractures
- · Fractures with Bone Loss
- Proximal and Distal Fractures
- Nonunions

Type of Use (Select one or both, as applicable)

2 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 A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue letter Z inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif, blue font.

P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131

# 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey, MA, RAC<br>Senior Project Manager, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | November 18, 2014 |
| Trade Name: | ITST® Intertrochanteric/Subtrochanteric Fixation System |
| Common Name: | Rod. Fixation, Intramedullary and Accessories |
| Classification Names<br>and References: | Intramedullary fixation rod<br>(21 CFR 888.3020, HSB) |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | M/DN® Intramedullary Fixation, manufactured by Zimmer<br>(K142281, cleared October 22, 2014). |
| Purpose and Device<br>Description: | The purpose of this submission is to obtain clearance for a<br>line extension to add 4.5mm Cortical Screws to the ITST<br>system. The ITST Intertrochanteric/ Subtrochanteric<br>Fixation System is used for closed nailing of the femur.<br>The system includes femoral intramedullary nails, lag<br>strews, anti-rotation screws, cortical screws and nail caps.<br>Cortical screws are used for distal locking of the nail. |
| Intended Use: | The ITST Intramedullary Nail is indicated for use in a<br>variety of femoral fractures, such as: Subtrochanteric<br>Fractures, Intertrochanteric Fractures, Comminuted<br>Fractures, Segmental Fractures, Fractures with Bone Loss,<br>Proximal and Distal Fractures, and Nonunions |

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| Comparison to Predicate Devices: | Both the subject ITST 4.5mm and predicate M/DN 4.2mm<br>devices are cortical screws with similar diameters. The<br>subject ITST 4.5mm Cortical Screws have identical<br>lengths to the predicate M/DN 4.2mm Cortical Screws.<br>Both devices are made from the same material and have<br>indications for use. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Shelf Life - Accelerated aging testing conducted<br>shows that the sterile devices included in this<br>submission have a shelf life of 10 years.Biocompatibility – Biocompatibility testing of the<br>subject devices was conducted per ISO 10993-1 and<br>Good Laboratory Practices (21 CFR 58). All testing<br>passed.Performance Evaluation -The dimensional |

- evaluation demonstrated that the subject ITST 4.5mm Cortical Screws are safe and effective and substantially equivalent to the predicate M/DN 4.2mm Cortical Screws.
Conclusions: The data presented in this submission show that the changes do not affect the safety and/or effectiveness of the subject devices and that the subject ITST devices will perform in a substantially equivalent manner to the predicate devices.

Clinical Performance and Conclusions:

Clinical trial data and conclusions were not needed for these devices to show substantial equivalence.