(72 days)
No
The provided text describes a prosthetic shoulder implant and its intended use. There is no mention of AI or ML technology in the device description, intended use, or the sections specifically looking for mentions of AI, DNN, or ML.
Yes
The device is a prosthetic replacement for the glenohumeral joint used to treat severe pain, significant disability, fractures, and avascular necrosis, which directly indicates a therapeutic purpose.
No
The device description clearly states it is a "monoblock glenoid component" intended for "prosthetic replacement" in shoulder arthroplasty, and the indications for use describe conditions requiring surgical intervention, not diagnosis.
No
The device description clearly describes a physical implantable device made of Trabecular Metal and polyethylene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for treating various conditions of the glenohumeral joint (shoulder). This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a prosthetic component (glenoid component) designed to be surgically implanted and articulate with other components. This is a medical device used for treatment, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other information. This device is a surgical implant used to replace a joint.
N/A
Intended Use / Indications for Use
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; un-united 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. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.
Product codes
KWS, KWT
Device Description
The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface composed of direct compression molded polyethylene (UHMWPE). The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449.
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)
Not Found
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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Zimmer TMT, Inc.
10 Pomeroy Road Parsippany, NJ 07054 973.576.0032 www.zimmer.com
JUN 2 9 2007
510(k) Summary
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathleen Rutherford
Associate Director, Regulatory Affairs
Telephone: (973) 576-0139
Fax: (973) 884-8795 |
| Date: | April 16, 2007 |
| Trade Name: | The Trabecular Metal Glenoid- the Bigliani/Flatow Complete Shoulder
Solution |
| Common Name: | Glenoid Component |
| Classification Name and
Reference:
Product Code: | Prosthesis, shoulder, semi & non-constrained, metal/polymer
cemented, 21 CFR 888.3660
KWS and KWT |
DEVICE DESCRIPTION
The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface composed of direct compression molded polyethylene (UHMWPE). The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449.
INDICATIONS FOR USE
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; un-united 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 non-
1
K071090 (pg. 2 of 2)
constrained arthroplasty is not acceptable. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.
SUBSTANTIAL EQUIVALENCE
Documentation was provided which demonstrated that the Gen III Trabecular Metal Glenoid B/F Complete Shoulder Solution is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation.
Device Technological Characteristics & Comparison to Predicate Device
The subject device possesses the same external articulating geometry and dimensions, the same minimum polyethylene thickness, and same sizing options as the predicate devices. The Trabecular Metal and direct compression molded UHMWPE materials, incorporated in the monoblock device are similar to numerous cleared Zimmer Trabecular Metal devices. This 510(k) covers changes in the geometry of the Trabecular Metal base, or keel, as well as a modification to the underside of the UHMWPE articular construct.
The modifications are designed to:
- increase the interfacial area for attachment between the Trabecular Metal and UHMWPE .
- increase the interfacial area between the UHMWPE and the bone cement mantle .
- decrease the likelihood of center pilot post damage during impaction/insertion .
- increase the overall fatigue and static strength of the Trabecular Metal base, making it less . susceptible to damage in instances where it is not completely supported
Conclusion
The Trabecular Metal Glenoid is substantially equivalent to the identified predicate TM Glenoid devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is centered and appears to be the heading of a document or page. The words are all capitalized and evenly spaced.
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007 Zimmer Trabecular Metal Technology, Inc.
% Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054
Re: K071090
Trade/Device Name: The Trabecular Metal Glenoid - the Bigliani/Flatow (B/F) Complete Shoulder Solution Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS. KWS. KWT Dated: April 16, 2007 Received: April 18, 2007
Dear Ms. Rutherford:
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 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.
3
Page 2 - Ms. Kathleen Rutherford
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K07 1090
Device Name: The Trabecular Metal Glenoid- Bigliani/Flatow® The Complete Shoulder Solution Indications for Use:
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatic disease of the glenohumeral joint; un-united 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. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
ign-Off Division of General, Restorative and Neurological Devices
510(k) Number k0 8517