(29 days)
No
The summary describes a mechanical implant (glenoid component) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a keeled glenoid component of a shoulder prosthesis, used to treat advanced wear and tear of the shoulder joint resulting from various forms of arthritis and for revision of shoulder prostheses, which are all therapeutic interventions.
No
The device, a keeled glenoid component for shoulder replacement, is intended for treatment of joint conditions and revision surgery, not for diagnosing them. Its purpose is to physically replace a damaged part of the shoulder, which is a therapeutic function.
No
The device description clearly states it is a "keeled glenoid component," which is a physical implant used in shoulder surgery. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- This device is a surgical implant (a keeled glenoid component) intended for cemented use within the shoulder joint to treat conditions like arthritis.
The description clearly indicates it's a physical component implanted during surgery, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
This device is intended for cemented use in the 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.
Product codes
KWS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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".
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K 051623 1 •
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 | |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Brandon Hipsher
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 | |
| Date: | June 16, 2005 | |
| Trade Name: | Anatomical Shoulder™ System Keeled Glenoid | |
| Common Name: | Shoulder Prosthesis | |
| Classification Name
and Reference: | Shoulder joint metal/polymer semi-constrained
cemented prosthesis
21 CFR § 888.3660 | |
| Predicate Device: | Anatomica All-Polyethylene Glenoid Component,
manufactured by Zimmer GmbH, K990136, cleared
March 1, 1999 | |
| Device Description: | 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. | |
| Intended Use: | This device is intended for cemented use in the
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. | |
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| 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.
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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
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