Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain; revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures.

The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

Device Description

The Coonrad Morrey Total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in regular, small and extra small sizes, in right and left configurations.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Coonrad/Morrey Total Elbow prosthesis. It is a submission for substantial equivalence to a predicate device, not a study evaluating a new AI/ML-based device. Therefore, the questions related to AI/ML device performance (acceptance criteria, sample sizes for test/training, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable to this document.

The document indicates that the modified device (modified stem lengths for ulnar assemblies) is substantially equivalent to its predicate device (Coonrad/Morrey Total Elbow, K001989).

Here's the relevant information based on your request, highlighting what is not applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This is a 510(k) submission for substantial equivalence of an updated mechanical implant, not an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" here is the demonstration of substantial equivalence.

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance
Device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.	Nonclinical analysis indicates that the modified device is substantially equivalent to the predicate.

2. Sample Sizes used for the Test Set and Data Provenance

Not Applicable for an AI/ML context. The submission mentions "nonclinical analysis" to support substantial equivalence. This would typically involve engineering analysis, bench testing, and comparisons to the predicate device's design specifications and performance, rather than a "test set" of patient data for an algorithm. No sample sizes for testing or data provenance are specified in this document.

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

Not Applicable. No "test set" in the context of AI/ML evaluation is described. The assessment relied on engineering and design comparison.

4. Adjudication Method for the Test Set

Not Applicable.

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

Not Applicable. This study is not relevant for a mechanical elbow prosthesis.

6. Standalone Performance Study (Algorithm Only)

Not Applicable. This is not an algorithm.

7. Type of Ground Truth Used

Not Applicable for an AI/ML context. The "ground truth" for this submission would be the established safety and effectiveness of the predicate device and engineering principles ensuring the modified device meets those standards.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML device.

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

Not Applicable.

Summary based on the document:

Device Type: Coonrad/Morrey Total Elbow, a metal/polymer constrained elbow prosthesis.
Submission Type: 510(k) premarket notification for substantial equivalence.
Modification: Ulnar Assemblies of modified stem length.
Predicate Device: Coonrad/Morrey Total Elbow (K001989).
Performance Data: "Results of nonclinical analysis indicate that the modified device is substantially equivalent to the predicate." This suggests engineering analysis and bench testing were performed to compare the modified device's characteristics (e.g., strength, fit) to the original.
The FDA concluded that the device is "substantially equivalent" for its stated indications for use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, stylized "Z" inside of a circle, followed by the word "zimmer" in a sans-serif font. The logo is black and white and appears to be a company logo.

KOS 3189

DEC 9 2005

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Laura D. Williams, RACManager, Corporate Regulatory AffairsTelephone: (574) 372-4523Fax: (574) 372-4605
Date:	November 11, 2005
Trade Name:	Coonrad/Morrey Total Elbow
Common Name:	Total Elbow Prosthesis
Classification Nameand Reference	Elbow joint metal/polymer constrained elbowprosthesis - 21 CFR § 888.3150
Predicate Device:	Coonrad/Morrey Total Elbow,manufactured by Zimmer, Inc.,K001989, cleared July 25, 2000

Device Description: The Coonrad Morrey Total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in regular, small and extra small sizes, in right and left configurations.

Intended Use:

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KCS3189 (pg 2 of 2)

Image /page/1/Picture/1 description: The image contains the logo for Zimmer. The logo consists of a large, stylized letter "Z" inside of a circle. To the right of the circle is the word "zimmer" in a smaller, sans-serif font.

Comparison to Predicate Device:

Ulnar Assemblies of modified stem length are being added to accommodate varying anatomy. All other dimensions will remain unchanged compared to the predicate devices.

Performance Data (Nonclinical and/or Clinical):

Results of nonclinical analysis indicate that the modified device is substantially equivalent to the predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.

DEC 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Laura D. Williams, RAC Manager, Corporate Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K053189

Trade/Device Name: Coonrad/Morrey Total Elbow Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: November 11, 2005 Received: November 15, 2005

Dear Ms. Williams:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 310(t) presidentially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate for use stated in the cherosure) to regally manetteent date of the Medical Device American be of Drya commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the Fed devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent appen to the general controls provisions of the Act. The r ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of use tice, 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 If your device is classified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations on may be subject to such additional controller Entroller Controller.
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peachartergarine your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a succession in other requirements of the Act that I'DA has made a decemination administered by other Federal agencies. You must or any Federal statutes and regulations annualing, but not limited to: registration and listing (21 comply with an the Ace 31equirements, and manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Laura D. Williams, RAC

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and myour he FDA finding of substantial equivalence of your device to a legally promation notineation: "The PDF and elessification 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 If you dosire 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 other Ectorers, 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K053189

Indications for Use

510(k) Number (if known):

Device Name:

Coonrad/Morrey Total Elbow

Indications for Use:

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) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number_ K053189

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”