Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatoid, 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 for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

Device Description

The New Zimmer Shoulder features modular and monoblock cobalt-chrome alloy humeral stems intended for use with or without cement in total shoulder arthroplasty. The cobaltchrome alloy humeral heads feature female Morse-type tapers which facilitate assembly with the modular humeral stems. The keeled glenoid component is manufactured from UHMWPE. It is intended for cemented use only.

AI/ML Overview

The provided text describes a 510(k) submission for the "New Zimmer Shoulder System." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the New Zimmer Shoulder System. Instead, it states:

Criterion	Reported Performance
Taper performance	"demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices."
Glenoid component performance	"demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices."

2. Sample Size for the Test Set and Data Provenance

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Performance Testing" section states that "Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices," but it does not specify what type of testing or how many samples were involved.

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

The document does not mention the use of experts to establish ground truth or their qualifications. The testing described appears to be device-specific mechanical or functional testing rather than clinical evaluation requiring expert consensus on patient data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as there is no indication of human-reviewed test sets or expert evaluations requiring adjudication.

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

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through component testing, not direct comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a physical shoulder joint prosthesis, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device would be based on engineering specifications, material science standards, and biomechanical parameters that define the safety and effectiveness of the components (taper and glenoid). The summary indicates that the testing demonstrated "safe and effective and substantially equivalent to predicate devices," implying that the performance was measured against established standards for shoulder prostheses.

8. Sample Size for the Training Set

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm requiring a training set.

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

This is not applicable as the device is a physical shoulder prosthesis, not an AI algorithm.

Summary

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K 982181

Image /page/0/Picture/1 description: The image shows the logo for Zimmer, which includes a stylized letter Z inside of a circle. The word "zimmer" is written in lowercase letters below the logo. The text "DEC 17" is visible in the upper right corner of the image.

P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131

Summary of Safety and Effectiveness New Zimmer Shoulder System

Submitted by
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

1998

Prepared by .

Laura D. Williams Specialist Regulatory Affairs Telephone: 219-372-4523 Fax: 219-372-4605

. IDate
August 25, 1998
. Trade Name
New Zimmer® Shoulder System
. Common Name
Shoulder Prosthesis

● Classification Name

Shoulder Joint Metal/Polymer Nonconstrained Cemented Prosthesis

Substantial Equivalence Summary .

The New Zimmer Shoulder System utilizes design features common to one or more of the following devices:

Device	K Number(s)	Decision Date
Fenlin Total Shoulder	K852137	2/12/86
Fenlin RCD Total Shoulder	K870262	4/3/87
Zimmer Total Shoulder II	K790987	6/22/79
3-M Neer II Shoulder Prosthesis	K895226	11/3/89

Image /page/0/Picture/22 description: The image shows a geometric design. The design appears to be a complex arrangement of triangles and lines, possibly forming a larger hexagonal or star-like shape. The image is black and white, which emphasizes the geometric patterns and lines. The design is intricate and symmetrical.

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Summary of Safety and Effectiveness New Zimmer Shoulder System (Continued)

Device	K Number(s)	Decision Date
3-M Modular Shoulder System	K920362	7/22/93
Osteonics Shoulder Components	K955731	3/5/96
	K962082	8/13/96
Kirschner Modular II-C Total Shoulder System	K940537	8/29/95
Intermedics Select Shoulder	K962315	9/3/96
	K962238	8/9/96
DePuy Global Total Shoulder	K914695	1/16/92

Device Description .

Intended Use

This prosthesis is intended to be implanted to replace a shoulder joint.

Prosthetic replacement with this device may be indicated for 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 for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

The components of the New Zimmer Shoulder System are intended for single use only. The glenoid component is designed for cement fixation only; the humeral stem may be implanted by press-fit or cement fixation.

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Summary of Safety and Effectiveness New Zimmer Shoulder System (Continued)

Performance Testing .

Testing performed on the taper and the glenoid component demonstrated that the New Zimmer Shoulder System is safe and effective and substantially equivalent to predicate devices.

RA07801K.510.D0C

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

DEC 17 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Laura D. Williams Specialist, Requlatory Affairs Zimmer, Inc. P.O. Box 708 46581-0708 Warsaw, Indiana

K982981 Re: The New Zimmer® Shoulder System Trade Name: Regulatory Class: III Product Codes: KWT and HSD Dated: August 25, 1998 August 26, 1998 Received:

Dear Ms. Williams:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laura D. Williams

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page | of |

510(k) Number (if known): Қ982981

Device Name: New Zimmer Shoulder System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

picòello

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K982981

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

RA07801K.510

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”