(29 days)
This device is intended for cemented use in treatment of the following:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- Omarthrosis.
- Rheumatoid arthritis.
- Revision of shoulder prosthesis.
- Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
The keeled glenoid component is part of the Anatomical Shoulder System. It provides surgeons with another bone anchorage option while maintaining the system's articular surface geometry.
This document is a Summary of Safety and Effectiveness for the Zimmer Anatomical Shoulder™ System Keeled Glenoid, which is a shoulder prosthesis.
Based on the provided text, the device's acceptance criteria and the study that proves it meets those criteria are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Testing completed as part of the design assurance process demonstrated that this device is safe. |
| Effectiveness | Testing completed as part of the design assurance process demonstrated that this device is effective. |
| Substantial Equivalence | The device is substantially equivalent to the predicate device (Anatomica All-Polyethylene Glenoid Component, Zimmer GmbH, K990136). The only modification is minor and does not change the intended use or fundamental scientific technology. |
| Manufacturing Processes | The device is manufactured, packaged, and sterilized using the same materials and processes as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- The document refers to "Testing completed as part of the design assurance process" which implies non-clinical testing.
- Sample Size: Not specified.
- Data Provenance: The data is described as "Non-Clinical Performance" and directly linked to "design assurance." This indicates in-house testing by the manufacturer (Zimmer, Inc.) rather than external or patient data. It is retrospective in the sense that it's part of the product development and verification process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The testing described is non-clinical performance, so it wouldn't involve expert establishment of ground truth in the same way clinical studies do. The "truth" here would be derived from engineering specifications and testing standards.
4. Adjudication Method for the Test Set
- This information is not provided. Given that the testing is non-clinical, an adjudication method for a test set (as typically seen in clinical trials with human readers/assessors) is not applicable or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
- No, a standalone study (in the context of an algorithm) was not done. This is a medical device (implant), not a software algorithm. The "standalone" performance here refers to the device's physical and mechanical performance, which was assessed through non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the non-clinical testing would be based on engineering specifications, mechanical testing standards, and established material properties. For example, tests for strength, wear, and fatigue would have predefined pass/fail criteria based on industry standards and the predicate device's performance.
8. The sample size for the training set
- Not applicable. This document describes a medical implant, not a device involving machine learning or AI that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable. As stated above, this device does not utilize AI/ML, so there is no training set or associated ground truth establishment in that context.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. A horizontal line is present below the word "zimmer".
+1
K 051623 1 •
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 | |
|---|---|---|
| Contact Person: | Brandon HipsherSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 | |
| Date: | June 16, 2005 | |
| Trade Name: | Anatomical Shoulder™ System Keeled Glenoid | |
| Common Name: | Shoulder Prosthesis | |
| Classification Nameand Reference: | Shoulder joint metal/polymer semi-constrainedcemented prosthesis21 CFR § 888.3660 | |
| Predicate Device: | Anatomica All-Polyethylene Glenoid Component,manufactured by Zimmer GmbH, K990136, clearedMarch 1, 1999 | |
| Device Description: | The keeled glenoid component is part of theAnatomical Shoulder System. It provides surgeonswith another bone anchorage option whilemaintaining the system's articular surface geometry. | |
| Intended Use: | This device is intended for cemented use in thetreatment of the following:Advanced wear and tear of the shoulderjoint resulting from degenerative,posttraumatic or rheumatoid arthritis.Omarthrosis.Rheumatoid arthritis.Revision of shoulder prosthesis.Traumatology: the only cone to be used intraumatological indications is thetraumatology cone. |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image contains the logo for Zimmer. The logo consists of a large, bold letter 'Z' enclosed in a circle, followed by the word 'zimmer' in a smaller, bold font. The 'Z' in the circle is the most prominent element, with the word 'zimmer' positioned to its right.
| ﻟﻤﺤﺎﻓﻈﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Comparison to Predicate Device:
Except for a minor modification, the Anatomical Shoulder Keeled Glenoid is identical to the predicate device. This modification does not change the intended use or the fundamental scientific technology. The device is manufactured, packaged and sterilized using the same materials and processes.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
JUL 19 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K051623
K051623
Trade/Device Name: Anatomical Shoulder™ System Keeled Glenoid Regulation Number: 21 CFR 888.3660 Kegulation Name: 21 CFR 866.5000
Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS Dated: June 16, 2005 Received: June 20, 2005
Dear Mr. Hipsher:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is a marketed in interstate for use stated in the enclosure) to legally marketed predicate devices marketed in interstant for use stated in the encrosule) to regary mancess producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance whiles approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the generation, listing of Y ou may, merefore, market the dovres, seejest to annual registration, listing of
general controls provisions of the Act include requirements for annual registerading and general controls provisions of the fist 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 (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation ED may be subject to such additional controls. Extrong mayor one of on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In a be found in the Code of Peach Regar
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 Please be advised that FDA s issualled of a budeum and other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decernmanon and Jour and Jour Federal agencies. You must in provision and ligit of any Federal statutes and regulations and interest by the not limited to: registration and issues and comply with an the Act 3 requirements, news manufacturing practice requirements as set CFK Part 807), idoeiing (21 CFR Part 801), good and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Mr. Brandon Hipsher
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will be of substantial equivalence of your device of your device to a legally prematicated predicated on "The 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 11 you a some of Compliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Companise market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal 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,
signature
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K051623 (1)
Indications for Use
510(k) Number (if known):
Device Name:
. . . .
Anatomical Shoulder™ System Keeled Glenoid
Indications for Use:
This device is intended for cemented use in treatment of the following:
- · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- · Omarthrosis.
- Rheumatoid arthritis.
- · Revision of shoulder prosthesis.
- · Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
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)
Eun.th
Cision Sign-Off) on of General, Restorative
Page 1 of 1
§ 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.”