the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration;
irreducible 3-and 4-part proximal humeral fractures;
avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Hemiarthroplasty/Total application:

the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration;
irreducible 3-and 4-part proximal humeral fractures;
avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

Device Description

The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.

AI/ML Overview

The provided document describes the acceptance criteria and a non-clinical study for the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (Compared to predicate device Zimmer Trabecular Metal™ Reverse Shoulder System, K052906)	Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices.
Similarity in Materials and Processes (to predicate device K052906)	The subject device is packaged, manufactured, and sterilized using the same or similar materials and processes as the predicate device.
Similar Intended Use (to predicate device K052906)	The subject device also has similar intended use as the predicate device.
Similar Fixation Methods (to predicate device K052906)	The subject device also has similar fixation methods as the predicate device.

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

The document does not specify a separate "test set" in the context of evaluating a medical imaging or AI device. Instead, it refers to non-clinical performance testing. No sample size for a test set (e.g., number of patients or images) is provided, as this is a medical device and not a diagnostic AI system with patient data.

The data provenance is non-clinical testing, meaning it likely involved bench testing, mechanical simulations, and material characterization rather than human subject data. The country of origin for the data is not explicitly stated beyond the submitter's location (Warsaw, IN, USA).

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

Not applicable. As this is a medical implant system and not an AI-driven diagnostic device evaluated with a test set requiring expert ground truth annotations, this information is not relevant to the described study. The "ground truth" for this type of device would be established by engineering and material science standards for safety and efficacy.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of "ground truth" establishment by experts or adjudication methods in the context of this non-clinical performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission (a shoulder implant device).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (shoulder implant), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant. The "standalone performance" of this device would refer to its physical function and integrity, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance evaluation is established through engineering standards, material specifications, and biomechanical principles. This includes demonstrating mechanical strength, durability, and biocompatibility that are comparable to or better than the predicate device. The document explicitly states "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices." This implies that the 'ground truth' for establishing safety and effectiveness relied on established scientific and engineering methodologies for implantable devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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Summary of Safety and Effectiveness

11/14 ు 1000

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene T. BinkleySenior Associate, Regulatory AffairsTelephone: (574) 372-4907Fax: (574) 372-4605
Date:	March 14, 2006
Trade Name:	Zimmer Trabecular Metal™ Reverse ShoulderSystem, Sizes 8mm and 10mm
Common Name:	Total-Shoulder System and Hemi-Shoulder System
Classification Nameand Reference:	1. Prosthesis, Shoulder, Semi-constrained,metal/polymer cemented (KWS)2. Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis (HSD)3. Shoulder joint metal/polymer non-constrainedcemented prosthesis (KWT)21 CFR § 888.3660, 888.3690 and 888.3650
Predicate Device:	Zimmer Trabecular Metal™ Reverse ShoulderSystem, manufactured by Zimmer, Inc., 510(k)K052906, cleared December 19, 2005.
Device Description:	The Zimmer Trabecular Metal™ Reverse ShoulderSystem is a modular total shoulder prosthesis thatwas designed specifically to include patients withnon-functional rotator cuffs. It was developed toeither encompass a traditional shoulder prostheses, areverse design or be transformed into a hemi-prosthesis depending on clinical cases encounteredduring the surgical procedure.

. . . . . . . . . . . . . . . . . . . . . . . . .

・・・・・

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Intended Use:

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

Reverse application:

the treatment of severe pain or significant o disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration; O
irreducible 3-and 4-part proximal humeral O fractures:
avascular necrosis of the humeral head, or other O difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Hemiarthroplasty/Total application:

the treatment of severe pain or significant 0 disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration; 0
irreducible 3-and 4-part proximal humeral o fractures:
avascular necrosis of the humeral head, or other റ difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

Comparison to Predicate Device: The Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are packaged, manufactured, and sterilized using the same or similar materials and processes as the predicate

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Image /page/2/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a stylized letter "Z" inside of a circle, followed by the word "zimmer" in lowercase letters. The letter "Z" and the word "zimmer" are both in black.

device. The subject device also has similar intended use and fixation methods as the predicate device.

Performance Data (Nonclinical and/or Clinical):

complete the station of the state of the same of the commended to

Non-Clinical Performance and Conclusions:

Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices.

・・・・・・・

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2006

Zimmer, Inc c/o Ms. Dalene T. Binkley Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K060704

Trade/Device Name: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, KWT Dated: April 25, 2006 Received: April 24, 2006

Dear Ms. Binkley:

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

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Page 2 - Ms. Dalene T. Binkley

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. 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/industry/support/index.html.

Sincerely yours.

Herbert Lewin us

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:

and the second the security of the state of the states of the

Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm

Indications for Use:

The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

Reverse application:

the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic ャ disease of the glenohumeral joint;
ununited humeral head fractures of long duration;
irreducible 3-and 4-part proximal humeral fractures;
avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Hemiarthroplasty/Total application:

ー the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
ununited humeral head fractures of long duration; -
irreducible 3-and 4-part proximal humeral fractures; -
avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

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

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

をしていますと思いますと、ここですまたまま

(Please do not write below this line - Continue

Concurrence of CDRH, Office of Delives Box of Carros Restorative and Neurological

Page 1 of 1

510(k) Number K060704

001

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and 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,” and
(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,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(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 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”