The DePuy Proximal Tibia Plating System is intended for treatment of nonunions, osteotomies, malunions, osteopenic bone and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic and fractures with associated shaft fractures.

Device Description

The technological characteristics of the DePuy Proximal Tibia Plating System are similar to the predicate devices including design and material.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "Proximal Tibia Plating System." It describes the device's intended use and its substantial equivalence to previously marketed devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

The document states: "The DePuy Proximal Tibia Plating System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This indicates that the demonstration of substantial equivalence relied on pre-clinical data, likely bench testing or engineering analyses, rather than clinical studies involving human subjects or extensive performance evaluations against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Based on the provided text, the following information is NOT available:

A table of acceptance criteria and the reported device performance: This document only describes the device and its intended use, not performance metrics or acceptance criteria.
Sample size used for the test set and the data provenance: No test sets or clinical data are mentioned. The equivalence is based on "pre-clinical data."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts or ground truth establishment is described.
Adjudication method for the test set: No test set or adjudication is mentioned.
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: This device is a bone fixation system, not an AI-powered diagnostic tool, so an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as it's not an algorithm.
The type of ground truth used: Not applicable, as there's no clinical performance study described.
The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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K090877 (pg. 1 of 1)

Section 5 — 510(k) Summary

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6441	JUN 26 2009
Contact Person:	Suzana Otaño, Project Manager, Regulatory Affairs
Date Prepared:	March 30, 2009
Proprietary Name:	Proximal Tibia Plating System
Common Name:	Plate, Fixation, Bone
ClassificationName:	Single/multiple component metallic bone fixation appliancesand accessories (21 CFR § 888.3030)
Predicate Devices:	The DePuy Proximal Tibia Plating System is substantiallyequivalent to currently marketed devices.
Intended Use:	The DePuy Proximal Tibia Plating System is intended fortreatment of nonunions, osteotomies, malunions, osteopenicbone and fractures of the proximal tibia, including simple,comminuted, lateral wedge, depression, medial wedge,bicondylar combination of lateral wedge and depression,periprosthetic and fractures with associated shaft fractures.
TechnologicalCharacteristics:	The technological characteristics of the DePuy Proximal TibiaPlating System are similar to the predicate devices includingdesign and material.
Summary ofSubstantialEquivalence:	The DePuy Proximal Tibia Plating System is substantiallyequivalent to currently marketed devices as demonstrated withpre-clinical data. No new issues of safety or efficacy havebeen raised.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

JUN 26 2009

9200 Corporate Boulevard

Food and Drug Administration

Public Health Service

Rockville MD 20850

DePuy Orthopaedics. Inc. % Ms. Suzana Otaño Project Manager 700 Orthopaedic Drive Warsaw, Indiana 46581

Re: K090877

Trade/Device Name: Proximal Tibia Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Codes: HRS, HWC Dated: March 30, 2009 Received: March 31, 2009

Dear Ms. Otaño:

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. .

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Suzana Otaño

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buellm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4 - Indications for Use Statement

510(k) Number:

Device Name:

K090877

Proximal Tibia Plating System

Indications For Use:

X Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (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)

(Division Sign-Off)

Division of Surgical, Orthopedia and Restorative Devices

510(k) Number K090872

Page 1 of 1

Proximal Tibia Plating System Traditional 510(k) DePuy Orthopaedics, Inc.

Page 19 of 112

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.