Comprehensive® Convertible Glenoid - Vivacit-E Liner

K211729 · Biomet Manufacturing Corp · PHX · Nov 4, 2021 · Orthopedic

Device Facts

• Record ID: K211729
• Device Name: Comprehensive® Convertible Glenoid - Vivacit-E Liner
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Nov 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. 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.

Device Story

Modular shoulder prosthesis for total joint replacement; replaces damaged/diseased natural shoulder joint to provide pain relief and restore function. System comprises baseplate (fixed to bone via screws) and modular liner. Subject device expands existing product line by introducing liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE). Implanted in clinical setting by orthopedic surgeons; device allows conversion between anatomic and reverse shoulder configurations without removing metal components. Output is physical restoration of joint mechanics; clinical benefit is improved shoulder function and pain reduction.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing including dissociation, shear, and insertion testing, alongside biocompatibility and packaging assessments.

Technological Characteristics

Modular shoulder prosthesis; glenoid baseplate with screw fixation; liner material: Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE). Design features include modularity for anatomic or reverse configurations. Sterilization: Ethylene Oxide (EtO).

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or cuff arthropathy requiring revision or primary shoulder arthroplasty. Reverse shoulder application indicated for patients with grossly deficient rotator cuff and severe arthropathy or failed prior replacement, provided patient is anatomically suited and has functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Comprehensive Convertible Glenoid (K130390)

Reference Devices

• Bio-Modular Shoulder System (K992119, K030710, K093803)
• Persona Revision Knee System (K191625)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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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

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Revision where other devices or treatments have failed.
- 4. Correction of functional deformity.
- 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

6. 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.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres<br>[e-mail]<br>[phone] |
| Date: | November 1, 2021 |
| Subject Device: | Trade Name: Comprehensive® Convertible Glenoid –<br>Vivacit-E Liner<br>Common Name: Shoulder prosthesis<br>Classification Name:<br>• PHX - Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis (21 CFR 888.3660) |
| | • KWS - Shoulder joint, metal/polymer, semi-<br>constrained, cemented prosthesis (21 CFR<br>888.3660) |
| | • KWT - Shoulder joint metal/polymer non-<br>constrained cemented prosthesis (21 CFR<br>888.3650) |
| | • PAO - Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis (21 CFR<br>888.3660) |
| | • MBF - Shoulder joint metal/polymer/metal<br>nonconstrained or semi-constrained porous-coated<br>uncemented prosthesis (21 CFR 888.3670) |

# Predicate Device(s):

| Device | Manufacturer | 510(k) Number |
|-----------------------------------------------------------------|----------------------------|------------------------------|
| Primary Predicate | | |
| Comprehensive<br>Convertible Glenoid | Biomet Manufacturing Corp. | K130390 |
| | | |
| Reference Predicates for Testing | | |
| Bio-Modular Shoulder<br>System | Biomet Manufacturing Corp. | K992119, K030710,<br>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<br>System | Zimmer Inc. | K191625 |
|---------------------------------|-------------|---------|
|---------------------------------|-------------|---------|

| Device | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | The proposed device is an orthopaedic total joint intended<br>to replace the damaged or diseased natural shoulder joint<br>in shoulder arthroplasty to provide pain relief and restore<br>function. It is modular in design, consisting of a baseplate<br>held to the bone with bone screws and a modular liner.<br>The device is designed to be implanted as the glenoid<br>component of an anatomic total shoulder with the option<br>to convert to a reverse shoulder configuration without<br>removal of the metal components. |
| | The current submission is to expand the product offering<br>by the addition of a liner manufactured from Vivacit-E<br>Vitamin E Highly Crosslinked Polyethylene (VEHXPE). |
| Indications for Use: | Anatomic Applications<br>1. Non-inflammatory degenerative joint disease<br>including osteoarthritis and avascular necrosis.<br>2. Rheumatoid arthritis.<br>3. Revision where other devices or treatments have<br>failed.<br>4. Correction of functional deformity.<br>5. Fractures of the proximal humerus, where other<br>methods of treatment are deemed inadequate.<br>6. Difficult clinical management problems, including<br>cuff arthropathy, where other methods of treatment<br>may not be suitable or may be inadequate. |
| | Reverse Applications<br>The Comprehensive Reverse Shoulder is indicated for use in<br>patients whose shoulder joint has a grossly deficient rotator<br>cuff with severe arthropathy and/or previously failed<br>shoulder joint replacement with a grossly deficient rotator<br>cuff. The patient must be anatomically and structurally<br>suited to receive the implants and a functional deltoid<br>muscle is necessary. |
| | Comprehensive Convertible Glenoid Baseplate<br>components are intended for cementless applications with<br>the addition of screw fixation. |

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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.