This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Pelvis II Implant System. The Pelvis II Implant System is an internal fixation device that consists of three different types of plates used with compatible screws to fit different types of fractures in the pelvis. The subject components will be available sterile and non-sterile.

AI/ML Overview

The provided text describes a 510(k) submission for the Pelvis II Implant System, which is an internal fixation device for pelvic fractures. It details the device's intended use, indications for use, and a comparison to a predicate device. The document explicitly states that clinical testing was not required for this submission.

Therefore, the study information requested (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) cannot be extracted from this document as no such clinical study was conducted or referenced for demonstrating the device meets performance acceptance criteria. The approval was based on non-clinical laboratory testing demonstrating substantial equivalence to a predicate device.

Here's a breakdown based on the provided text's limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission states, "Clinical testing was not required for this submission." The approval was based on substantial equivalence demonstrated through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No clinical test set was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. No clinical test set with expert ground truth was used.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical testing was not required for this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a medical implant device, not an AI/algorithm device.

7. The Type of Ground Truth Used:

Not applicable. No clinical ground truth was established as clinical testing was not required. The "ground truth" for substantial equivalence was based on predefined mechanical properties and performance standards for similar orthopedic implants, demonstrated through non-clinical laboratory testing.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/algorithm device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/algorithm device that requires a training set.

Summary of Device Performance and Acceptance Criteria from Non-Clinical Testing:

The document briefly mentions non-clinical testing:

Acceptance Criteria (Implied): Mechanical performance standards and characteristics deemed substantially equivalent to the predicate device (K001614 - Stryker Trauma Pelvic Set). These would typically involve metrics like static strength, fatigue life, and possibly material properties, all of which are common for orthopedic implants.
Reported Device Performance: "Testing demonstrated that the Pelvis II Implant System is substantially equivalent to the predicate device currently cleared for marketing."
Study: "Stryker Pelvis II Static and Fatigue Plate Testing" was performed.

This 510(k) submission relied on demonstrating substantial equivalence through mechanical and material testing, rather than clinical performance data against specific acceptance criteria relevant to diagnostic accuracy or clinical outcomes.

Summary

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K131132

510(k) Summary

Proprietary Name:

Common Name:

Classification Name and Reference:

Device Class:

Product Code(s):

For Information Contact:

April 22, 2013

Date Prepared:

Description:

Intended Use:

The Pelvis II Implant System is intended for reconstruction, stabilization and rigid fixation of fractures in the pelvis in adult patients.

MAY 3 1 2013

Pelvis II Implant System

Bones Screws Bone Plates

Single/multiple component metallic bone fixation appliances and accessories 21 CFR §888.3030

Class II

HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone

Elijah N. Wreh Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: 201-831-5691 Fax: 201-831-4691

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Indications for Use:

Indications for the Pelvis II Implant System will include fractures of the following regions of the pelvis:

. Anterior Column
. Anterior Column combined with posterior hemi-transverse
. Quadrilateral surface

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the following device:

K001614 - Stryker Trauma Pelvic Set , .

Non-Clinical Testing:

Non-clinical laboratory testing was performed for the Pelvis II Implant System components to determine substantial equivalence. Testing demonstrated that the Pelvis II Implant System is substantially equivalent to the predicate device currently cleared for marketing.

The following test was performed:

Stryker Pelvis II Static and Fatigue Plate Testing .

Clinical Testing:

Clinical testing was not required for this submission:

Conclusion:

The Pelvis II Implant System is substantially equivalent to the predicate device identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: May 31, 2013

Stryker Trauma AG % Mr. Elijah Wreh Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K131132

Trade/Device Name: Pelvis II Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: May 1, 2013 Received: May 2, 2013

Dear Mr. Wreh:

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-Gosmetic-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 hability w 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

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Page 2 - Mr. Elijah Wreh

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" (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

510(k) Number (if Known): K131132

Device Name: Pelvis II implant System

Indications for Use:

Indications for the Pelvis II implant System will include fractures of the following regions of the pelvis ring:

하 Anterior Column
Anterior Column combined with posterior hemi-transverse #
Quadrilateral surface .

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Elizabeth L. Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 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.