(279 days)
No
The summary describes a mechanical shoulder implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
This device is a shoulder implant system, which is surgically implanted to restore function and relieve pain in patients with severe shoulder joint conditions, fitting the definition of a therapeutic device.
No
The provided text describes a shoulder implant system used for surgical replacement of the shoulder joint, which is a therapeutic device. It does not mention any diagnostic functions, such as identifying or detecting diseases or conditions.
No
The device description clearly outlines physical components like Humeral Stem, Humeral Head Adapter, and Humeral Head, indicating it is a hardware-based medical device for shoulder arthroplasty.
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 designed to replace or repair the shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis, which are physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status through in vitro analysis.
- Clinical and Non-Clinical Tests: The tests described (FEA, fatigue, range of motion, etc.) are typical for evaluating the mechanical and functional performance of a surgical implant, not the analytical performance of a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 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 alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres 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
Device Description
The Identity Shoulder System 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 comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty 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 constructed is intended to be used with a compatible glenospheres/baseplate component.
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:
- FEA o
- o Axial Pull Off
- Torsional Disassociation O
- Micro-Motion O
- Fatigue O
- Accelerated Corrosion O
- Range of Motion O
- MRI O
Clinical Tests: ● 0 None provided
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.
K193038 Comprehensive Shoulder System
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.
K193373 Comprehensive Reverse Shoulder, K181611 Comprehensive Reverse Shoulder System, K193099 Anatomical Shoulder System, K103404 Bigliani Flatow Shoulder, K840643 Harris Galante Porous Total Hip System
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
September 15, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around an emblem. To the right, there is a blue square with the letters "FDA" in white. Next to the square, the text "U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue.
Zimmer Inc. Patricia Sandborn Beres Regulatory Affairs Principal P.O Box 708 Warsaw, Indiana 46581-0708
Re: K213856
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 Dated: September 14, 2022 Received: September 15, 2022
Dear Patricia Sandborn 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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,
For Victoria Lilling, M.D. 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213856
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 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 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 alloys are inferior to that of cobalt alloy. A Titanium humeral head or Glenospheres 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
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4
510(k) Summary
In accordance with content and format of a 510(k) summary (21 CFR §807.92) and the Safe Medical Devices Act of 1990, the following information is provided for the Identity Shoulder System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.
| Sponsor: | Zimmer Inc.
P.O. Box 708
Warsaw, IN 46581-0708
Establishment Registration Number: 1822565 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres
Regulatory Affairs Principal
Telephone: (574)-376-5271
patty.beres@zimmerbiomet.com |
| Date: | September 13, 2022 |
| Subject Device: | Trade Name: Identity Shoulder System
Common Name: Shoulder joint replacement device |
| | Classification Name:
• MBF -Shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3670)
• KWT - Shoulder joint metal/polymer nonconstrained
cemented prosthesis (21 CFR 888.3650)
• KWS - Shoulder joint metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3660)
• HSD - Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis (21 CFR 888.3690)
• PHX -Shoulder joint metal/polymer semi-constrained
cemented prosthesis (21 CFR 888.3660) |
| Predicate Device(s): | Primary Predicate Device
K193038 Comprehensive Shoulder System
Reference Devices
K193373 Comprehensive Reverse Shoulder
K181611 Comprehensive Reverse Shoulder System
K193099 Anatomical Shoulder System
K103404 Bigliani Flatow Shoulder
K840643 Harris Galante Porous Total Hip System |
5
Purpose and Device Description:
The Identity Shoulder System 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 comprises of several individual components such as Humeral Stem, Fixed Angle Humeral Stem Adapter, Humeral Head Adapter, and Humeral Head. This configuration can be used as a hemiarthroplasty 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 constructed is intended to be used with a compatible glenospheres/baseplate component.
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
6
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 not recommended for patients who lack suspected material sensitivity to cobalt alloy.
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to predicates ●
- Indications for Use: Identical to predicates ●
- Materials: Identical to predicates ●
- . Design Features: Similar to predicates; differences are mainly dimensional and have been shown to not raise different questions of safety and effectiveness.
- Sterilization: Identical to predicates
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests/Justifications:
- FEA o
- o Axial Pull Off
- Torsional Disassociation O
- Micro-Motion O
- Fatigue O
- Accelerated Corrosion O
- Range of Motion O
- MRI O
Summary of Technological Characteristics:
7
- Clinical Tests: ● 0 None provided
Substantial Equivalence Conclusion
The proposed Identity Shoulder System has the same intended use and indications for use as the predicate device. The proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:
- any differences do not raise new questions of safety ● and effectiveness; and
- . the proposed device is as safe and effective as the legally marketed predicate device.