The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T", straight "L" and oblique "L" configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

AI/ML Overview

Here's an analysis of the provided text regarding the Zimmer Universal Locking System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (bone plates and screws). For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical properties (e.g., strength, fatigue life) rather than diagnostic accuracy as one might find for an AI-powered diagnostic tool. Similarly, "ground truth" and "expert consensus" are not applicable in the same way. The document explicitly states that clinical data and conclusions were not needed for this device. This means there was no study involving human patients to assess its clinical performance in terms of diagnostic effectiveness. The evaluation was primarily based on non-clinical (laboratory) performance testing and demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance equivalent to predicate device for internal fracture fixation.	Test results "demonstrate that the device is safe and effective." (Specific quantitative criteria and results are not provided in this summary.)
Biocompatibility equivalent to predicate device.	Manufactured from the "same materials" as the predicate device. (Implying equivalent biocompatibility).
Similar design characteristics to predicate device.	"Similar in design to the predicate device."

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

Sample Size for Test Set: Not explicitly stated as this was a non-clinical (laboratory) performance study, not a clinical trial with patient data. The "test set" would consist of manufactured devices subjected to various mechanical tests.
Data Provenance: Non-clinical (laboratory) testing. Not applicable for country of origin or retrospective/prospective as it doesn't involve patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not Applicable. This device is a bone plating system, not a diagnostic tool requiring expert interpretation of results. "Ground truth" in this context would be defined by engineering specifications and material science standards.

4. Adjudication Method for the Test Set

Not Applicable. As there was no expert review of patient data, no adjudication method like 2+1 or 3+1 was used. The evaluation would have been based on engineering measurements and comparisons to design specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not an AI-powered diagnostic device, so a MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance Study

No. This device does not involve an algorithm. The assessment was of the physical device itself.

7. Type of Ground Truth Used

Engineering Specifications and Material Science Standards. For a medical implant like this, "ground truth" would be defined by established mechanical and material properties required for safe and effective internal fixation, typically based on industry standards, validated testing methods, and comparison to the predicate device's known performance.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this device's evaluation. This is a physical product, not a machine learning model.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the Zimmer logo. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the word 'zimmer' in a smaller, sans-serif font. The 'Z' in the circle is the most prominent element, drawing the eye with its size and enclosure.

Summary of Safety and Effectiveness

K063303

NOV 2 2 2006

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony FrancalanciaSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605
Date:	October 31, 2006
Trade Name:	Zimmer® Universal Locking System
Common Name:	2.7mm Locking Plate System
Classification Nameand Reference:	Plate, Fixation, Bone (21 CFR § 888.3030)Screw, Fixation, Bone (21 CFR § 888.3040)
Predicate Device:	Zimmer® Universal Locking System 3.5mm Platesand Screws, manufactured by Zimmer, Inc.,K060710, cleared April 26, 2006.
Device Description:	The Zimmer Universal Locking System is a plateand screw system intended for internal fracturefixation. The plate selection consists of dualcompression, reconstruction, tubular, straight "T",straight "L" and oblique "L" configurations. Platesaccommodate either standard or locking screws viafigure-8 shaped holes.
Intended Use:	The Universal Locking System is indicated fortemporary internal fixation and stabilization ofosteotomies and fractures, including comminutedfractures, supracondylar fractures, extra-articularfractures, fractures in osteopenic bone, nonunionsand malunions.
Comparison to Predicate Device:	The Zimmer Universal Locking System 2.7mmplates and screws have the same intended use,similar performance characteristics, are

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a stylized letter "Z" enclosed in a circle, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white.

manufactured from the same materials and are similar in design to the predicate device.

Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and are connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer. Inc. % Mr. Anthony Francalancia Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

NOV 2 2 2006

Re: K063303

Trade/Device Name: Universal Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codc: HRS Dated: October 31, 2006 Received: November 1, 2006

Dear Mr. Francalancia:

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 such 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); 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.

{3}------------------------------------------------

Page 2 – Mr. Anthony Francalancia

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210 Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

Barbara Buechner

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

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Universal Locking System, 2.7mm Locking Plates and Screws

Zimmer Universal Locking Plate System

Indications for Use:

The Universal Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including;

Comminuted fractures .
Supracondylar fractures .
Extra-articular fractures .
Fractures in osteopenic bone .
Nonunions .
Malunions .

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 if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Starbare bruchn

(Division Sign-Cif) Division of General, Restorative, and Neurological Devices

510(k) Number K063303

Page 1 of 1

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.