Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

K172502 · Biomet Manufacturing Corp · PHX · Jan 3, 2018 · Orthopedic

Device Facts

• Record ID: K172502
• Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Jan 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Biomet Comprehensive 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 Comprehensive 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. Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application 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 applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Story

Comprehensive Augmented Glenoid Baseplates and alternate versions of existing Standard/Mini Baseplates; intended for reverse shoulder arthroplasty. Devices feature augmented backside geometry (three sizes: Small, Medium, Large) to address anatomical needs; utilize porous plasma spray (PPS) coating and Zimmer Calcicoat coating for fixation. Used in surgical settings by orthopedic surgeons for total shoulder replacement. Provides structural support for shoulder joint reconstruction in patients with rotator cuff deficiency. Benefits include pain relief and restoration of function. No changes to base geometry; manufacturing process updated for coating application.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including PPS and HA/TCP coating pore size/porosity analysis and glenoid loosening/disassociation shear testing.

Technological Characteristics

Shoulder joint prosthesis components. Materials: substrate and porous coating consistent with predicates; includes Calcicoat® (HA/TCP) coating. Features: augmented backside geometry (Small, Medium, Large). Fixation: cementless with screw fixation or cemented. Sterilization: validated methods consistent with predicates.

Indications for Use

Indicated for patients with grossly deficient rotator cuff and severe arthropathy, or failed shoulder joint replacement with gross rotator cuff deficiency. Requires functional deltoid muscle and suitable anatomy. Indicated for primary, fracture, or revision total shoulder replacement for pain relief and disability. Titanium glenospheres indicated for patients with Cobalt Alloy sensitivity.

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 Reverse Shoulder – Mini Baseplate (K120121)
• Comprehensive Reverse Shoulder (K080642)
• Equinoxe Reverse Total Shoulder System (K110708)
• Comprehensive Reverse Shoulder – Titanium Glenosphere (K131353)

Submission Summary (Full Text)

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January 3, 2018

Biomet Manufacturing Corp Patricia Sandborn Beres Regulatory Affairs Specialist 56 E. Bell Drive Warsaw, Indiana 46582

Re: K172502

Trade/Device Name: Comprehensive Augments, Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, PAO, KWS, KWS, KWT, MBF Dated: December 1, 2017 Received: December 4, 2017

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K172502 |
| Device Name | Comprehensive Reverse Shoulder Standard and Mini Baseplates<br>Comprehensive Augmented Glenoid Baseplates |
| Indications for Use (Describe) | Biomet Comprehensive 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 Comprehensive 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. |
| | |
| | Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy. |
| | |
| | Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application 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 applications. 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 shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside, followed by the words "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color. The logo is clean and modern, and it is likely used to represent the company's brand.

### 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Comprehensive Glenoid Components 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 August 12, 2005.

| Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1835034 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres<br>Regulatory Affairs Principal<br>Telephone: [phone])<br>Fax: fax [phone]) |
| Date: | January 3, 2018 |
| Subject Device: | Trade Name: Comprehensive Augmented Glenoid Components,<br>Comprehensive Standard Baseplate, Comprehensive Mini Baseplate<br>Common Name: Shoulder Replacement Prosthesis<br>Classification Name:<br>• PHX- Shoulder Prosthesis, Reverse Configuration (21<br>CFR888.3660)<br>• PAO- prosthesis, shoulder, semi-constrained, metal/polymer +<br>additive, cemented (21 CFR 888.3660)<br>• KWS - prosthesis, shoulder, semi-constrained, metal/polymer<br>cemented (21 CFR 888.3660)<br>• KWT - prosthesis, shoulder, non-constrained, metal/polymer<br>cemented (21 CFR 888.3650)<br>• MBF - prosthesis, shoulder, semi-constrained, metal/polymer,<br>uncemented (21 CFR 888.3670) |

### Predicate Device(s):

| Device | Manufacturer | 510(k) Number |
|----------------------------------------------------------|----------------|---------------|
| Comprehensive Reverse Shoulder – Mini<br>Baseplate | Biomet, Inc. | K120121 |
| Comprehensive Reverse Shoulder | Biomet, Inc. | K080642 |
| Equinoxe Reverse Total Shoulder System | Exactech, Inc. | K110708 |
| Comprehensive Reverse Shoulder – Titanium<br>Glenosphere | Biomet, Inc | K131353 |

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| Purpose and Device Description: | This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates\ components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.<br><br>The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and Indications for Use: | <b>Reverse Applications:</b><br>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.<br><br>The Comprehensive 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.<br><br>Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.<br><br>Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.<br><br>Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. |

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## Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: Identical to predicate ●
- Indications for Use: Identical to predicate
- Materials: Substrate and porous coating is the same as the . predicate; Calcicoat® coating has been previously cleared for orthopedic products
- Design Features: Identical or similar to predicates .
- Sterilization: Identical assurance level and validation methods to ● predicate (new vendor)

#### Summary of Performance Data:

| <b>Non-Clinical Tests:</b> PPS and HA/TCP Coating Pore Size and Porosity Glenoid Loosening/Disassociation Test Method Shear testing justification <b>Clinical Tests:</b> None provided |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Substantial Equivalence Conclusion:</b> The proposed Comprehensive Glenoid Baseplates have the same intended use and indications for use as the predicate devices. The proposed devices have 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 devices are at least as safe and effective as the legally marketed predicate devices.