Rush Medullary Pins by Zimmer, Inc.

Rush Medullary Pins are indicated for use in fixation of bone fractures, for bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.

Device Description

The Rush Medullary Pin is inserted into the medullary canal of long bones to provide internal shaft fracture fixation. It achieves stabilization through the opposition of dynamic forces. The beveled point enables the surgeon to insert from the side of the bone with little chance of driving the pin through the opposing cortex. These devices are made from stainless steel.

AI/ML Overview

The provided text is for a medical device (Rush Medullary Pins) that is a physical implant used for bone fixation, not an AI/ML powered device. Therefore, the questions related to AI/ML device performance, such as sample size for training/test sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.

The document discusses the substantial equivalence of the Rush Medullary Pins to a predicate device.

Acceptance Criteria and Device Performance (Based on "Comparison to Predicate Device" and "Performance Data" sections):

Acceptance Criteria	Reported Device Performance
Biocompatibility	Biocompatibility testing on the Rush Pin material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
Material Mechanical Properties	The subject devices conformed to material mechanical property standard ISO 5838-1.
Bending Strength	An engineering analysis showed that the subject and predicate devices have identical material and cross-sectional geometrical properties, and their bending strengths are substantially equivalent.
Shape	The subject Rush Medullary Pins are identical in shape to the predicate devices.
Materials	The subject Rush Medullary Pins are identical in materials to the predicate devices.
Performance Characteristics	The subject Rush Medullary Pins are identical in performance characteristics to the predicate devices.
Substantial Equivalence (Overall)	The data presented in the submission demonstrate that the subject devices are substantially equivalent to the predicate devices, despite differences in length (diameters are equivalent to predicate devices). The indications for use were also shown to be substantially equivalent. The subject device is provided non-sterile, as is the predicate device, further establishing equivalence.

Study Details:

Sample size used for the test set and the data provenance: Not applicable. The evaluation was based on non-clinical performance (biocompatibility, material properties, engineering analysis) and comparison to a predicate device, not on a test set of data like in AI/ML studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood in AI/ML is not relevant for this type of device submission.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device, not an AI/ML product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used: Not applicable. The "ground truth" here is compliance with established standards (ISO 10993-1, ISO 5838-1) and demonstrating substantial equivalence to a legally marketed predicate device through physical and engineering properties.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

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 P.O. Box 708 Warsaw, Indiana 46581

Re: K150626

Trade/Device Name: Rush Medullary Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 10, 2015 Received: March 11, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

May 1, 2015

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Page 2 - Mr. Stephen H. McKelvey

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.

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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name Rush Medullary Pins

Indications for Use (Describe)

Rush Medullary Pins are indicated for use in fixation of bone reconstruction, and for skeletal traction in alignment of long bone fracture segments.

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

×
Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

Page 1 of 1

ng Services (301) 443-6740 EF 9

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Image /page/3/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in lowercase blue letters. The font used for "zimmer" is sans-serif and appears to be a custom design.

510(k) Summary
Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Stephen H. McKelveySenior Project Manager, Trauma Regulatory AffairsTelephone: (574) 372-4944Fax: (574) 371-8760
Date:	March 10, 2015
Trade Name:	Rush Medullary Pins
Common Name:	Rush Pins
Classification Namesand References:	Pin, Fixation, Smooth (HTY)21 § CFR 888.3040, Smooth or threaded metallic bonefixation fastener
Classification Panel:	Orthopedics/87
Predicate Device(s):	Ortho Solutions Limited Trauma Implants forOsteosynthesis (including Rush Medullary Pins)K110895 - cleared 12/19/2011
Purpose and Device Description:	The Rush Medullary Pin is inserted into the medullarycanal of long bones to provide internal shaft fracturefixation. It achieves stabilization through the oppositionof dynamic forces. The beveled point enables the surgeonto insert from the side of the bone with little chance ofdriving the pin through the opposing cortex. Thesedevices are made from stainless steel.
Intended Use:	Rush Medullary Pins are indicated for use in fixation ofbone fractures, for bone reconstruction, and for skeletaltraction in alignment of long bone fracture segments.

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Comparison to Predicate Device:	The subject Rush Medullary Pins are identical in shape,materials, and performance characteristics to the predicatedevices. Only the lengths of the subject and predicatedevices differ. The subject Rush Medullary Pins withdiameters equivalent to the predicate devices but withdifferent lengths were shown to be substantially equivalentto the predicate devices. The indications for use for thesubject and predicate devices were shown to besubstantially equivalent. The subject device is providednon-sterile as is the predicate device.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:

Comparison to Predicate Device:

The subject Rush Medullary Pins are identical in shape,materials, and performance characteristics to the predicatedevices. Only the lengths of the subject and predicatedevices differ. The subject Rush Medullary Pins withdiameters equivalent to the predicate devices but withdifferent lengths were shown to be substantially equivalentto the predicate devices. The indications for use for thesubject and predicate devices were shown to besubstantially equivalent. The subject device is providednon-sterile as is the predicate device.

Performance Data (Nonclinicaland/or Clinical):

Non-Clinical Performance and Conclusions:

· Biocompatibility Biocompatibility testing on the Rush Pin material was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
· Performance Evaluation The subject devices were considered for conformance to material mechanical property standard ISO 5838-1, and were found to be in conformance with the standard. The engineering analysis shows the subject and predicate devices have identical material and cross-sectional geometrical properties, their bending strengths are substantially equivalent.

Conclusions: The data presented in this submission demonstrate that the subject devices are substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

· Clinical data and conclusions were not needed for this submission.

Regulation Number and Section

§ 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.