Alliance Augmented Glenoid

K193180 · Zimmer, Inc. · KWS · Feb 24, 2020 · Orthopedic

Device Facts

• Record ID: K193180
• Device Name: Alliance Augmented Glenoid
• Applicant: Zimmer, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Feb 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5. Difficult clinical management problems, where other methods of treatment may not 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. The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

Device Story

Alliance Augmented Glenoid is a shoulder joint prosthesis component; part of a total shoulder replacement system. Device features an augmented wedge (12.5-degree) on the undersurface to correct glenoid bone defects. Inputs: patient anatomy during surgical implantation. Operation: surgeon implants glenoid component into the glenoid cavity; modular posts (Tivanium substrate with Trabecular Metal sleeve or Porous Plasma Spray coating) provide fixation. Used in clinical settings by orthopedic surgeons. Output: physical prosthetic surface for humeral head articulation. Benefit: restores joint function and corrects bone deformity in patients with degenerative or traumatic shoulder conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, specifically glenoid loosening (rocking horse) testing per ASTM F2028.

Technological Characteristics

Materials: UHMWPE and Ti-6Al-4V. Modular posts feature Tivanium substrate with Trabecular Metal (TM) sleeve or Porous Plasma Spray (PPS) coating. Design: 12.5-degree augment wedge added to undersurface. Sterilization: Gamma radiation (SAL 10-6). Testing: ASTM F2028 (Glenoid Loosening/Rocking Horse).

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or difficult clinical management cases requiring total shoulder replacement. Optional use in revision procedures where healthy bone stock exists.

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

• Alliance Glenoid (K191814)
• Aequalis Perform+ (K150583)

Submission Summary (Full Text)

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February 24, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.

Zimmer Inc. Patricia Beres Regulatory Affairs Principal P.O. Box 708 WARSAW, IN 46581-0708

## Re: K193180

Trade/Device Name: Alliance Augmented Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT Dated: January 23, 2020 Received: January 24, 2020

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 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Michael C. Owens Acting 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

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# Indications for Use

510(k) Number (if known) K193180

Device Name Alliance Augmented Glenoid

#### Indications for Use (Describe)

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- 2. Rheumatoid arthritis.
- 3. Correction of functional deformity.
- 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- 5. Difficult clinical management problems, where other methods of treatment may not 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.

The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span><span>Prescription Use (Part 21 CFR 801 Subpart D)</span></div> | |
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span><span>Over-The-Counter Use (21 CFR 801 Subpart C)</span></div> | |

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## 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 ALLIANCE AUGMENTED GLENOID 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: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708<br>Establishment Registration Number: 1822565 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres<br>Regulatory Affairs Principal<br>Telephone: [phone] extension 1278)<br>Email: [e-mail] |
| Date: | November 15, 2019 |
| Subject Device: | Trade Name: Alliance Augmented Glenoid<br>Common Name: Anatomic Glenoid Prosthesis |
| | Classification Name:<br>• KWS - Prosthesis Shoulder, Semi-Constrained<br>Metal/Polymer Cemented (21 CFR 888.3660)<br>• KWT - Prosthesis, Shoulder, Non-Constrained<br>Metal/Polymer (21 CFR 888.3650) |

Predicate Device(s):

| Predicates | Device | Manufacturer | 510(k)<br>Number |
|---------------------|-------------------|--------------|------------------|
| Primary Predicate | Alliance Glenoid | Zimmer, Inc. | K191814 |
| Reference Predicate | Aequalis Perform+ | Tornier | K150583 |

## Purpose and Device Description:

The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular

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glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

- 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis. 2.
- 3. Correction of functional deformity.
- 4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
- 5. Difficult clinical management problems, 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.

The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

Summary of Technological Characteristics:

The following items are identical between the proposed and predicate devices:

- . Indications for use
- Articulating Geometry
- Sizing (Size 2-5) ●
- . Modular Post attachment
- Polyethylene peripheral peg design and splay
- Material (UHMWPE and Ti-6Al-4V) ●
- Sterilization method (gamma radiation, SAL 10-6) ●
- Instrument Materials

This submission proposed the following design change:

- Addition of a 12.5-degree augment wedge to the ● under surface of the component.
- Addition of associated implant specific instruments ●

## Intended Use and Indications for Use:

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- Updated packaging/sterilization references ●
## Summary of Performance Data (Nonclinical and/or Clinical)

- Non-Clinical Tests: ●
- o Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Clinical Tests: ● O None provided

Substantial Equivalence Conclusion

The proposed Alliance Augmented Glenoid 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 at least as safe and effective as the legally marketed predicate device