(84 days)
Not Found
No
The description focuses on the mechanical design and materials of a prosthetic implant, with no mention of AI or ML for diagnosis, treatment planning, or device function.
Yes
The device is a prosthetic replacement indicated for the treatment of severe pain, significant disability, and various degenerative, traumatic, or disease-related conditions of the glenohumeral joint, aiming to restore functionality and alleviate symptoms.
No
The device is a prosthetic replacement (humeral stem) intended for surgical implantation to treat severe pain or disability in the glenohumeral joint, not to diagnose a medical condition.
No
The device description clearly describes a physical implant (humeral stem) made of metal, intended for surgical replacement of a shoulder joint. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint due to various musculoskeletal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (humeral stem) designed for surgical implantation. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information about a patient's health status.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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, 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 arthoplasty 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 of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
Product codes
KWT, HSD
Device Description
The Zimmer Trabecular Metal Humeral Stem is intended to be a single use only implant that is used to replace a shoulder joint. This humeral stem uses Trabecular Metal around the proximal part of the stem for biological ingrowth. It also has an anti-rotational fin, a proximal stem collar, suture holes, and a distal fluted stem body. Stems are available in sizes ranging in diameter from 9-18mm and in the lengths of 130mm and 170mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint; humeral head; 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 testing demonstrated that the Zimmer Trabecular Metal Humeral Stem is 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
§ 888.3650 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.”
0
K041549 142
SEP - 1 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley, RAC
Associate, Regulatory Affairs
Telephone: (574) 372-4907
Fax: (574) 372-4605 |
| Date: | August 27, 2004 |
| Trade Name: | Zimmer Trabecular Metal™ Humeral Stem |
| Common Name: | Total Shoulder System |
| Classification Name
and Reference: | Shoulder joint metal/polymer non-constrained
cemented prosthesis. 21 CFR § 888.3650
Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis. 21 CFR § 888.3690 |
| Predicate Device: | The predicate and design basis for the Zimmer
Trabecular Metal" Humeral Stem is the New
Zimmer Shoulder System (Bigliani/Flatow)
(K982981, cleared Dec.17, 1998) and the Bio-
Modular Shoulder System by Biomet, Inc.
(K992119, cleared Sept. 13, 1999). |
| Device Description: | The Zimmer Trabecular Metal Humeral Stem is
intended to be a single use only implant that is used
to replace a shoulder joint. |
| | This humeral stem uses Trabecular Metal around
the proximal part of the stem for biological
ingrowth. It also has an anti-rotational fin, a
proximal stem collar, suture holes, and a distal
fluted stem body. Stems are available in sizes
ranging in diameter from 9-18mm and in the lengths
of 130mm and 170mm. |
1
KO9154t
effective as the predicate devices.
2002
Intended Use: 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 arthoplasty 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 of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. Comparison to Predicate Device: The Zimmer Trabecular Metal Humeral Stem is packaged, manufactured, and sterilized using the same materials and processes as the predicate devices. The subject device also has the same intended use and fixation methods as the predicate devices. Performance Data (Nonclinical Non-Clinical Performance and Conclusions: and/or Clinical): Non-clinical testing demonstrated that the Zimmer Trabecular Metal Humeral Stem is as safe and
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above two wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2004
Ms. Dalene Binkley, RAC Associate, Regulatory Affairs Zimmer. Inc. P.O. Box 708 Warsaw, Indiana 46581
Re: K041549
Trade/Device Name: Trabecular Metal Humeral Stem Regulation Number: 21 CFR 888.3650; 21 CFR 888.3690 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis; Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Regulatory Class: Class II Product Code: KWT, HSD Dated: June 3, 2004 Received: June 9, 2004
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 10 woo wavenor 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); labcling (21 CFR Part 801); good manufacturing practice requirements as set Crrc rate 877, accems (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. Dalene Binkley, RAC
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark H. Milliken
Celia M. Witten, Ph.D., M.D. 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):
Device Name:
Zimmer Trabecular Metal™ Humeral Stem
Indications for Use:
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 arthoplasty 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 of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
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)
Division of General, Restorative
and Neurological Devices
510(K) Number K041549 Page 1 of 1