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

The provided submission K082527 describes a Zimmer Universal Locking System: 3.5mm Locking Plates and Screws. This is a physical orthopedic device and therefore the acceptance criteria and study described will not align with typical AI/ML device evaluations. The summary indicates that non-clinical (laboratory) performance testing was conducted to demonstrate safety and effectiveness. This means no studies involving human subjects or AI/ML evaluations are described in this document.

For the requested information:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria Reported Device Performance
Device safety Demonstrated safe
Device effectiveness Demonstrated effective
Performance characteristics Similar to predicate devices
Sample size used for the test set and the data provenance: Not applicable. The device is a physical orthopedic implant. Performance was evaluated through non-clinical laboratory testing, not a dataset of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering and biomechanical testing specifications, not expert consensus on medical images or diagnoses.
Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of medical cases, not for the performance testing of physical orthopedic implants.
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: No, an MRMC study was not done. This device is an orthopedic implant, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: For this physical device, the "ground truth" would be established by engineering specifications, material properties, and biomechanical performance standards adhered to during non-clinical laboratory testing.
The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the conventional sense.
How the ground truth for the training set was established: Not applicable.

Acceptance Criteria	Reported Device Performance
Device safety	Demonstrated safe
Device effectiveness	Demonstrated effective
Performance characteristics	Similar to predicate devices

Summary

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K082527

DEC 1 8 2008

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Anthony Francalancia, RACSenior Associate, Regulatory AffairsTelephone: (574) 372-4570Fax: (574) 372-4605
Date:	August 29, 2008
Trade Name:	Zimmer® Universal Locking System: 3.5 mmLocking Plates and Screws (Tivanium® Ti-6Al-4VAlloy, CP Grade Titanium)
Common Name:	3.5mm TiULS 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"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:○ Comminuted fractures○ Supracondylar fractures○ Extra-articular fractures○ Fractures in osteopenic bone○ Nonunions○ Malunions

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Comparison to Predicate Device:

The Zimmer Universal Locking System: 3.5mm Locking Plates and Screws (Tivanium Ti-6A1-4V Alloy, CP Grade Titanium) have the same intended use, similar performance characteristics and are similar in design to the prodicate devices.

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 cffective.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC 1 8 2008

Re: K082527

Trade/Device Name: Zimmer® Universal Locking System: 3.5 mm Locking Plates and Screw (Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium) 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: December 8, 2008 Received: December 9, 2008

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

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Page 2 - Mr. Anthony Francalancia

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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 System: 3.5 mm Locking Plates and Screws (Tivanium® Ti-6Al-4V Alloy, CP Grade Titanium)

Indications for Use:

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

Comminuted fractures o
Supracondylar fractures .0
Extra-articular fractures o
O Fractures in osteopenic bone
Nonunions ಂ
Malunions 0

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of 1
510(k) Number	K082527

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.