(75 days)
Not Found
No
The document describes a mechanical shoulder implant system and its components, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical and range of motion analysis.
Yes.
The device is an orthopedic implant (shoulder replacement system) used to treat degenerative joint disease, fractures, and other functional deformities, which are therapeutic interventions.
No
This device is an implantable orthopedic system (shoulder arthroplasty) designed for treatment, not for diagnosing conditions.
No
The device description clearly states it is a "comprehensive collection of components" including physical implants like Humeral Stem, Humeral Head, Humeral Tray, and Humeral Bearing. The 510(k) is for additional sizes/styles of these physical components. This is a hardware medical device, not software-only.
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 replacing or repairing the shoulder joint due to various conditions like arthritis, fractures, and rotator cuff deficiency. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a collection of components (stems, heads, trays, bearings) designed for surgical implantation in the shoulder. This aligns with a medical device used in surgery, not a diagnostic test performed on biological samples.
- 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) to provide information for diagnosis, monitoring, or screening.
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
Hemiarthoplasty/Conventional Total Application:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Correction of functional deformity.
- · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. 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 may be used cemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Product codes (comma separated list FDA assigned to the subject device)
MBF, KWT, KWS, HSD, PHX, PAO
Device Description
The Identity Shoulder System cleared previously in K213856 is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component.
The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 Tests/Justifications:
• Finite Element Analysis (FEA)
· Range of Motion Analysis
· Magnetic Resonance Imaging (MRI)
Clinical Tests None provided
Conclusion
Non-clinical testing demonstrated that the new devices do not represent new worst-case configurations than the predicate, and the subject device is substantially equivalent to the predicate device identified.
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.
K213856, K201315, K220914, K181611
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
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
0
June 12, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
Zimmer Inc. Patricia Beres Regulatory Affairs Principal 1800 West Center St. Warsaw, Indiana 46580
Re: K240876
Trade/Device Name: Identity Shoulder System Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porouscoated uncemented prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWS, HSD, PHX, PAO Dated: May 2, 2024 Received: May 2, 2024
Dear Patricia Beres:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Joseph P. Joseph P. Russell -S Russell-s Date: 2024.06.12 15:56:26 -04'00"
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Identity Shoulder System
Indications for Use (Describe)
Hemiarthoplasty/Conventional Total Application:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- · Rheumatoid arthritis.
- · Correction of functional deformity.
- · Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are indicated for use in patients whose shoulder ioint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. 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 may be used cemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K240876 Page 1 of 3
| 510(k) #: K240876 | 510(k) Summary | | K240876 Page 1 of 3
Prepared on: 2024-05-02 | 21 CFR 807.92(a)(1) |
|-----------------------------------------------------------|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------------------|
| Contact Details | | | | |
| Applicant Name | | Zimmer Inc. | | |
| Applicant Address | | 1800 West Center St. Warsaw IN 46580 United States | | |
| Applicant Contact Telephone | | 754-376-5271 | | |
| Applicant Contact | | Ms. Patricia Beres | | |
| Applicant Contact Email | | patty.beres@zimmerbiomet.com | | |
| Device Name | | | | 21 CFR 807.92(a)(2) |
| Device Trade Name | | Identity Shoulder System | | |
| Common Name | | Shoulder joint metal/polymer/metal nonconstrained or semi-constrained
porous-coated uncemented prosthesis | | |
| Classification Name | | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | | |
| Regulation Number | | 888.3670 | | |
| Product Code(s) | | MBF, KWT, KWS, HSD, PHX, PAO | | |
| Legally Marketed Predicate Devices
21 CFR 807.92(a)(3) | | | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | | Product Code |
| K213856 | Identity Shoulder System | | | MBF |
| K201315 | PERFORM Humeral System - Stem | | | PAO |
| K220914 | Tornier Perform Humeral System - Fracture | | | PHX |
| K181611 | Comprehensive Reverse Shoulder System | | | PHX |
Device Description Summary
21 CFR 807.92(a)(4)
The Identity Shoulder System cleared previously in K213856 is a comprehensive collection of components designed with the intention of providing the modularity and adaptability necessary to facilitate individual anatomical adjustment and restoration of the glenohumeral joint during shoulder arthroplasty.
The Identity Shoulder System in the anatomic configuration is comprised of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head. This configuration can be used as a hemi-athroplasty with the humeral head articulating against the natural glenoid bone or as an anatomic total shoulder replacement with a compatible glenoid component.
The components of the Identity Shoulder System may also be used in the reverse configuration. Individual components include a Humeral Stem, Humeral Tray and Humeral Bearing, This construct is intended to be used with a compatible glenosphere/baseplate component.
The current 510(k) is for additional sizes/styles of humeral trays and bearings for the reverse configuration. Extra Extended trays in 3 heights in a neutral configuration are being additional lateralization. A uniforn thickness
5
K240876 Page 2 of 3
bearing is also being added in an effort to improve internal/external range of motion and reduce potential of scapular notching.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Hemiarthoplasty/Conventional Total Application:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- · Correction of functional deformity.
· Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Difficult clinical management problems, including cuff arthropathy, where other may not be suitable or may be inadequate.
Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
Reverse Application:
Zimmer Biomet Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Zimmer Biomet Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
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 may be used cemented or uncemented (biological fixation).
The Titanium Humeral Head and Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy.
Indications for Use Comparison
The indications for use of the subject devices are identical to the primary predicate Identity Shoulder System.
Technological Comparison
The proposed device has similar technological characteristics as the primary predicate system.
The following items are identical to the predicate Identity Shoulder System, cleared in K213856.
• Component Materials, raw and contact
• MRI Conditional Status and MRI language
- Sterilization methods and validations
- · Packaging materials, methods and validations
- Shelf Life validations
· Biocompatibility
The rationale for substantial equivalence is based on consideration of the following characteristics:
- · Materials: Identical to primary predicate device
- · Design Features: Similar to predicate devices
- Packaging: Identical to predicate devices
- · Sterilization: Identical to primary predicate device
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-Clinical Tests/Justifications:
• Finite Element Analysis (FEA)
· Range of Motion Analysis
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
· Magnetic Resonance Imaging (MRI)
Clinical Tests None provided
Conclusion
Non-clinical testing demonstrated that the new devices do not represent new worst-case configurations than the predicate, and the subject device is substantially equivalent to the predicate device identified.