(139 days)
Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing and analysis.
Yes
The device is indicated for the treatment of severe pain or significant disability due to various conditions affecting the glenohumeral joint, aiming to restore function and alleviate symptoms.
No
Explanation: The Zimmer Trabecular Metal Shoulder System is described as a shoulder prosthesis intended for surgical replacement (arthroplasty) due to various joint pathologies, not for identifying or diagnosing a disease.
No
The device description and intended use clearly describe a physical orthopedic implant system (shoulder prostheses, base plates, humeral stems, glenoid components) used for surgical procedures. There is no mention of software as the primary or sole component of the device.
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 treating conditions of the shoulder joint (degenerative disease, fractures, avascular necrosis, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a shoulder prosthesis, which is a physical implant.
- Anatomical Site: The device is used within the body (glenohumeral joint, humeral head, proximal humeral). IVDs are used in vitro (outside the body) to examine specimens from the body.
- Performance Studies: The performance studies focus on mechanical testing of the implant (fatigue, micro-motion, screw pullout), which is typical for orthopedic devices, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting markers, or providing diagnostic information.
Therefore, the Zimmer Trabecular Metal Shoulder System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthroplasty/Total 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 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. 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 (comma separated list FDA assigned to the subject device)
PHX, KWT, KWS, HSD
Device Description
The proposed Base Plates and Humeral Stems are a line extension of the Zimmer Trabecular Metal Reverse Shoulder System, which consists of conventional and reverse, semi- and non-constrained shoulder prostheses for total or hemiarthroplasty 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, humeral head, proximal humeral
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)
Performance testing was conducted on the proposed devices per FDA's Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. Also, testing/analysis were performed to evaluate the safety of the device based on risks identified in Zimmer's Design Failure Mode Effects Analysis (DFMEA). This included fatigue testing/analysis of the Base Plate and the Humeral Stems. Additionally, micro-motion and screw pullout forces were analyzed/compared between the predicate base plate and the proposed base plate with increased lateral offset.
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3650 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
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
Re: K121543
Trade/Device Name: Zimmer Trabecular Metal 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: August 31, 2012 Received: September 4, 2012
Dear Mr. Francalancia:
This letter corrects our substantially equivalent letter of October 11, 2012.
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. Iisting 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/ResourcesforYou/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
121543(i/j)
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Trabecular Metal Shoulder System
Indications for Use:
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthroplasty/Total 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 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. In 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
б
(Please do not write below this line - Continue on another page if needed) Device Evaluation (ODE) Page 1 of 1 ion of Surgical. Orthopedic 510(k) Number
3
121543 (1/3)
.
OCT 1 1 2012
Summary of Safety and Effectiveness
.
zummer
| Sponsor: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anthony Francalancia
Senior Specialist, Regulatory Affairs
Telephone: (574) 372-4570
Fax: (574) 372-4605 |
| Date: | October 11, 2012 |
| Trade Name: | Zimmer® Trabecular Metal™ (TM) Reverse
Shoulder System, Base Plates and Humeral Stems |
| Product Code / Device: | KWT - Shoulder joint metal/polymer non-
constrained cemented prosthesis. KWS - Shoulder
joint metal/polymer semi-constrained cemented
prosthesis. HSD - Shoulder joint humeral (hemi-
shoulder) metallic uncemented prosthesis. |
| Regulation Number / Description: | 21 CFR § 888.3650 - Shoulder joint metal/polymer
non-constrained cemented prosthesis. 21 CFR §
888.3660 - Shoulder joint metal/polymer semi-
constrained cemented prosthesis. 21 CFR §
888.3690 - Shoulder joint humeral (hemi-shoulder)
metallic uncemented prosthesis. |
| Predicate Device: | Zimmer Trabecular Metal Reverse Shoulder
System, manufactured by Zimmer, K052906,
cleared December 19, 2005.
Zimmer Trabecular Metal Reverse Shoulder
System, manufactured by Zimmer, K060704,
cleared May 19, 2006. |
| Device Description: | The proposed Base Plates and Humeral Stems are a
line extension of the Zimmer Trabecular Metal
Reverse Shoulder System, which consists of
conventional and reverse, semi- and non- |
3
4
K121543(2/3)
Intended Use:
constrained shoulder prostheses for total or hemiarthroplasty applications.
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthronlasty/Total 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 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).
5
K12/543 (3/3)
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.
The proposed devices are line extensions to the predicate devices. They share the same indications for use/intended use, utilize the same materials and manufacturing processes, and have similar technical features as their predicates.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
Performance testing was conducted on the proposed devices per FDA's Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. Also, testing/analysis were performed to evaluate the safety of the device based on risks identified in Zimmer's Design Failure Mode Effects Analysis (DFMEA). This included fatigue testing/analysis of the Base Plate and the Humeral Stems. Additionally, micro-motion and screw pullout forces were analyzed/compared between the predicate base plate and the proposed base plate with increased lateral offset.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.