The Universal Locking 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 and malunions.

Device Description

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" and oblique "T" configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Zimmer Universal Locking System." It is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria in a detailed clinical study.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size) is not present in this type of regulatory submission because it is not required for a 510(k) clearance process.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not provided. A 510(k) submission generally does not include specific quantitative acceptance criteria tables and detailed performance data against them in the same way a PMA would. Instead, it refers to equivalence to predicate devices.
The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." However, it does not provide the specific results or the acceptance criteria used for this testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document only mentions "non-clinical (laboratory) performance testing," which implies mechanical or bench testing. It does not refer to a "test set" in the context of clinical data or human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical "test set" with expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical "test set" is described.

5. 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 device is a mechanical bone fixation system, not an AI-driven diagnostic or assistive tool for human readers. No MRMC study would be relevant or expected for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical bone fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in the traditional sense. For a mechanical device, "ground truth" typically relates to engineering specifications, material properties, and biomechanical performance rather than clinical diagnoses. The document mentions "non-clinical (laboratory) performance testing," which would assess parameters like strength, fatigue life, etc., often against established industry standards for predicate devices.

8. The sample size for the training set

Not applicable/Not provided. This device does not involve machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. As above, no training set for AI is involved.

Summary of what is available:

Device: Zimmer Universal Locking System (plate and screw system for internal fracture fixation).
Study described: "Non-clinical (laboratory) performance testing."
Purpose of testing: To demonstrate that the device is "safe and effective" and comparable to predicate devices. The document explicitly states: "The Zimmer Universal Locking System plates have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices."
Predicate Devices: Zimmer® ECT® Internal Fracture Fixation system and Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684).

In the context of a 510(k) for a conventional medical device like this, the "study that proves the device meets the acceptance criteria" is the non-clinical (laboratory) performance testing that shows substantial equivalence to the predicate devices in terms of performance characteristics. The acceptance criteria would generally be that the device performs at least as well as or similarly to the predicate devices in relevant biomechanical and material tests. However, the specific details of those tests and their numerical acceptance criteria are not included in this high-level summary.

Summary

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Image /page/0/Picture/0 description: The image shows the Zimmer logo. The logo consists of a circle with a stylized "Z" inside it, followed by the word "zimmer" in lowercase letters. The "Z" is black, and the circle is white with a black outline.

Traditional 510(k) Premarket Notification

Summary of Safety and Effectiveness

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Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony FrancalanciaSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605
Date:	March 15, 2006
Trade Name:	Zimmer® Universal Locking System
Common Name:	3.5mm Locking Plate System
Classification Nameand Reference:	Plate, Fixation, Bone (21 CFR § 888.3030)Screw, Fixation, Bone (21 CFR § 888.3040)
Predicate Devices:	Zimmer® ECT® Internal Fracture Fixation system(Pre-amendment device).Synthes Small Fragment Dynamic CompressionLocking (DCL) System (K000684, cleared April 28,2000).
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"and oblique "T" 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 plates havethe same intended use, similar performance

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Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.

characteristics, are manufactured from similar materials and are similar in design to the predicate devices.

Performance Data:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 2005

Zimmer, Inc. c/o Mr. Anthony Francalancia Senor Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K060710

Trade/Device Name: Zimmer Universal Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS. HWC Dated: March 15, 2006 Received: March 16, 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 max 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. Your 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

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Page 2 - Mr. Anthony Francalancia

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. 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nil RP Ozil
Mark N. Melkerson

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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Indications for Use

510(k) Number (if known):

Device Name:

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)

(Division Sign-Off)

Niel R.C. Ogle for mxp

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Division of General, Restorative, and Neurological Devices

510(k) Number K060710

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.