(153 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a total joint replacement intended to relieve pain and restore function in a damaged or diseased shoulder joint, which are therapeutic aims.
No
The device description clearly states it is an orthopaedic total joint intended to replace a damaged or diseased natural shoulder joint, and the indications for use describe conditions for which it would be implanted, not diagnosed.
No
The device description clearly states it is an "orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint," which is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes a device for replacing a damaged or diseased shoulder joint through surgery. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details an orthopedic total joint replacement system, including components like a baseplate, liner, and stems. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant used to treat conditions affecting the shoulder joint.
N/A
Intended Use / Indications for Use
Anatomic Applications
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- 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.
Reverse Applications
The Comprehensive Reverse Shoulder is 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 neeessary.
Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWT, PAO, MBF
Device Description
The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components.
The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).
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:
- Dissociation Testing
- Shear Testing
- Insertion Testing
- Biocompatibility Assessment
- Packaging Assessment
Clinical Tests:
- None provided
Substantial Equivalence Conclusion:
Based on the information contained within this submission, it is concluded that the Comprehensive Convertible Glenoid - Vivacit-E Liner is substantially equivalent to the identified predicate and reference devices. The subject device has similar technological characteristics to the previously cleared devices, and the performance data and analyses demonstrate that:
- . anv differences do not raise new questions of safety and effectiveness; and
- the proposed device is as safe and effective as the legally marketed predicate devices.
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.
K992119, K030710, K093803, K191625
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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biomet Manufacturing Corp. Patricia Beres Regulatory Affairs Principal 56 East Bell Drive Warsaw, Indiana 46582
November 4, 2021
Re: K211729
Trade/Device Name: Comprehensive® Convertible Glenoid - Vivacit-E Liner Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, PAO, MBF Dated: October 5, 2021 Received: October 7, 2021
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 (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 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
1
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 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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 Jiping Chen, PhD Acting Division 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211729
Device Name
Comprehensive® Convertible Glenoid - Vivacit-E Liner
Indications for Use (Describe)
Anatomic Applications
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis.
-
- Revision where other devices or treatments have failed.
-
- 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.
Reverse Applications
The Comprehensive Reverse Shoulder is 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 neeessary.
Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
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)
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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a contrast against the white background.
510(k) Summary
| Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres
patty.beres@zimmerbiomet.com
(574) 267-6639 |
| Date: | November 1, 2021 |
| Subject Device: | Trade Name: Comprehensive® Convertible Glenoid –
Vivacit-E Liner
Common Name: Shoulder prosthesis
Classification Name:
• PHX - Shoulder joint metal/polymer semi-
constrained cemented prosthesis (21 CFR 888.3660) |
| | • KWS - Shoulder joint, metal/polymer, semi-
constrained, cemented prosthesis (21 CFR
888.3660) |
| | • KWT - Shoulder joint metal/polymer non-
constrained cemented prosthesis (21 CFR
888.3650) |
| | • PAO - Shoulder joint metal/polymer semi-
constrained cemented prosthesis (21 CFR
888.3660) |
| | • MBF - Shoulder joint metal/polymer/metal
nonconstrained or semi-constrained porous-coated
uncemented prosthesis (21 CFR 888.3670) |
Predicate Device(s):
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| Primary Predicate | ||
| Comprehensive | ||
| Convertible Glenoid | Biomet Manufacturing Corp. | K130390 |
| Reference Predicates for Testing | ||
| Bio-Modular Shoulder | ||
| System | Biomet Manufacturing Corp. | K992119, K030710, |
| K093803 | ||
| Reference Predicates for Materials, Sterilization and Packaging |
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a darker shade of gray.
| Persona Revision Knee
| System | Zimmer Inc. | K191625 |
|---|---|---|
| --------------------------------- | ------------- | --------- |
| Device | |
|---|---|
| Description: | The proposed device is an orthopaedic total joint intended |
| to replace the damaged or diseased natural shoulder joint | |
| in shoulder arthroplasty to provide pain relief and restore | |
| function. It is modular in design, consisting of a baseplate | |
| held to the bone with bone screws and a modular liner. | |
| The device is designed to be implanted as the glenoid | |
| component of an anatomic total shoulder with the option | |
| to convert to a reverse shoulder configuration without | |
| removal of the metal components. | |
| The current submission is to expand the product offering | |
| by the addition of a liner manufactured from Vivacit-E | |
| Vitamin E Highly Crosslinked Polyethylene (VEHXPE). | |
| Indications for Use: | Anatomic Applications |
- Non-inflammatory degenerative joint disease
including osteoarthritis and avascular necrosis. - Rheumatoid arthritis.
- Revision where other devices or treatments have
failed. - 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. |
| | Reverse Applications
The Comprehensive Reverse Shoulder is 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. |
| | Comprehensive Convertible Glenoid Baseplate
components are intended for cementless applications with
the addition of screw fixation. |
5
Image /page/5/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: Identical to primary predicate ●
- Indications for Use: Identical to primary predicate ●
- Materials: Identical to reference predicate
- Design Features: Identical to primary predicate with the exception of removal of cosmetic tabs
- . Sterilization: The predicate Convertible Glenoid E1 Liners were Gamma sterilized whereas the subject Convertible Glenoid Vivacit-E Liners are EtO sterilized similar to the reference predicate device.
Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests: ●
- Dissociation Testing O
- Shear Testing O
- Insertion Testing O
- Biocompatibility Assessment O
- Packaging Assessment O
Clinical Tests: ●
- 0 None provided
Substantial Equivalence Conclusion
Based on the information contained within this submission, it is concluded that the Comprehensive Convertible Glenoid - Vivacit-E Liner is substantially equivalent to the identified predicate and reference devices. The subject device has similar technological characteristics to the previously cleared devices, and the performance data and analyses demonstrate that:
- . anv differences do not raise new questions of safety and effectiveness; and
- the proposed device is as safe and effective as the legally marketed predicate devices.