(58 days)
No
The document describes a mechanical implant system for shoulder arthroplasty and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a prosthesis intended to treat severe pain or disability in the glenohumeral joint, indicating a therapeutic purpose.
No
The device is a shoulder prosthesis used for arthroplasty (replacement of a joint), not for diagnosing medical conditions.
No
The device description clearly states it consists of "conventional and reverse, semi- and non constrained shoulder prostheses," which are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating conditions of the shoulder joint (degenerative disease, fractures, avascular necrosis, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description confirms it's a shoulder prosthesis, which is a physical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The anatomical site is the shoulder joint, which is consistent with a surgical implant.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthroplasty/Total application:
- 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.
Reverse application:
- 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 (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) 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 humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.
Product codes
PHX, KWT, KWS, HSD
Device Description
The Zimmer Trabecular Metal Reverse Shoulder System consists of conventional and reverse, semi- and non constrained shoulder prostheses for total or hemiarthroplasty applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
glenohumeral joint, 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 Performance and Conclusions:
The components of the Zimmer Trabecular Metal Reverse Shoulder System have been evaluated for compatibility in the MRI environment, per Guidance for Industry and FDA Staff, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", August 2008. Based upon the results, the subject shoulder implants are recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this submission
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052906, K060704, K121543, K122692
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a human profile.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2016
Zimmer, Incorporated Mr. Anthony Francalancia Senior Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K130661
Trade/Device Name: Zimmer® Trabecular Metal™ Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS, HSD Dated: March 11, 2013 Received: March 18, 2013
Dear Mr. Francalancia:
This letter corrects our substantially equivalent letter of May 9, 2013.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
1
Page 2 - Mr. Anthony Francalancia
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
SIO(k) Number (if known): K130661
Device Name:
Zimmer® Trabecular Meta[TM Reverse Shoulder System
Indications for Use:
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemjartbroplasty!fotal applicatjop:
- 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.
Reverse application:
-
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 (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) 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 humeral components are intended for either cemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. fn the USA. the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.
| Prescription Use X | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
{Please do not write below this line -Continue on another page if needed )
Concurrence of CORH, Office of Device Evaluation (ODE)
Page I of I
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3
K130661 (1/3)
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
510(k) Summary
MAY 0 9 2013
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Names/References:
Classification Panel:
Predicate Device(s):
Zimmer. Inc. P.O. Box 708 Warsaw. IN 46581-0708
Anthony Francalancia Senior Specialist, Regulatory Affairs Telephone: (574) 372-4570 Fax: (574) 372-4605
March 11, 2013
Zimmer® Trabecular Metal™ Reverse Shoulder System
Reverse Shoulder System Implants
KWT - 21 CFR § 888.3650 - Shoulder joint metal/polymer non-constrained cemented prosthesis. KWS - 21 CFR & 888.3660 - Shoulder joint metal/polymer semi-constrained cemented prosthesis. HSD - 21 CFR § 888.3690 -Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
Orthopedics/87
Zimmer Trabecular MetalTM Reverse Shoulder System. manufactured by Zimmer, K052906, cleared December 19. 2005.
Zimmer® Trabecular MetalTM Reverse Shoulder System, Sizes 8mm and 10mm, manufactured by Zimmer, K060704, cleared May 19, 2006.
Zimmer® Trabecular MetalTM Reverse Shoulder System, Base Plates and Humeral Stems, manufactured by Zimmer, K121543, cleared October 11, 2012. Zimmer Trabecular Metal™ Reverse Shoulder System,
Non-Porous Humeral Stems, manufactured by Zimmer. K 122692, cleared December 3, 2012.
Purpose and Device Description:
The Zimmer Trabecular Metal Reverse Shoulder System consists of conventional and reverse, semi- and non
4
Intended Use:
constrained shoulder prostheses for total or hemiarthroplasty applications.
Indications for Use: The Zimmer Trabecular Metal Shoulder System is indicated for the following: Hemiarthroplasty/Total application:
- 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.
Reverse annlication:
- 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 (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) 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 arthroplastv (conventional or reverse applications).
The humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.
Comparison to Predicate Device:
This submission is for a labeling modification to the predicates. The labeling modification consists of the
36
5
K130661 (3/3)
addition.of Magnetic Resonance Imaging (MRI) compatibility information to the Package Insert, and application of the "MR Conditional" symbol on the package label.
Non-Clinical Performance and Conclusions:
The components of the Zimmer Trabecular Metal Reverse Shoulder System have been evaluated for compatibility in the MRI environment, per Guidance for Industry and FDA Staff, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", August 2008. Based upon the results, the subject shoulder implants are recommended to bear the "MR Conditional" labeling and include MR compatibility safety information within the package insert.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this submission
Performance Data (Nonclinical and/or Clinical):