(64 days)
No
The provided text describes a modular shoulder prosthesis and its intended uses. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on non-clinical testing demonstrating safety and effectiveness compared to predicate devices, not on the performance of an AI/ML algorithm.
Yes
The device is a modular total shoulder prosthesis indicated for treating severe pain or disability from various conditions of the glenohumeral joint, thereby providing therapeutic relief.
No
Explanation: The device is a surgical implant (shoulder prosthesis) used for treatment, not for diagnosing medical conditions.
No
The device description clearly states it is a "modular total shoulder prosthesis," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Zimmer Trabecular Metal Reverse Shoulder System is a modular total shoulder prosthesis. Its intended use is for the surgical treatment of various conditions affecting the glenohumeral joint and proximal humerus. This involves implanting a device into the body, not performing tests on samples outside the body.
The information provided describes a surgical implant used to replace or repair a joint, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
KWS, HSD, KWT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, shoulder
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 testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices.
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.”
0
Image /page/0/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 a bold, sans-serif font. The logo is black and white.
Summary of Safety and Effectiveness
11/14 ు 1000
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley
Senior Associate, Regulatory Affairs
Telephone: (574) 372-4907
Fax: (574) 372-4605 |
| Date: | March 14, 2006 |
| Trade Name: | Zimmer Trabecular Metal™ Reverse Shoulder
System, Sizes 8mm and 10mm |
| Common Name: | Total-Shoulder System and Hemi-Shoulder System |
| Classification Name
and Reference: | 1. Prosthesis, Shoulder, Semi-constrained,
metal/polymer cemented (KWS)
2. Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis (HSD)
3. Shoulder joint metal/polymer non-constrained
cemented prosthesis (KWT)
21 CFR § 888.3660, 888.3690 and 888.3650 |
| Predicate Device: | Zimmer Trabecular Metal™ Reverse Shoulder
System, manufactured by Zimmer, Inc., 510(k)
K052906, cleared December 19, 2005. |
| 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. |
. . . . . . . . . . . . . . . . . . . . . . . . .
・・・・・
1
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 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.
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
2
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.
:
・・・・・・・
3
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
4
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
5
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 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.
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