Alliance Glenoid

K191814 · Zimmer, Inc. · KWS · Oct 23, 2019 · Orthopedic

Device Facts

• Record ID: K191814
• Device Name: Alliance Glenoid
• Applicant: Zimmer, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Oct 23, 2019
• 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 Glenoid is a series of shoulder glenoid components; includes monoblock polyethylene (2 or 3 pegs) and modular glenoids (3 or 4 pegs). Modular central posts utilize Tivanium substrate with either Trabecular Metal (TM) sleeve or Porous Plasma Spray (PPS) coating. Device used with existing humeral stem/head components for total shoulder replacement. Implanted by orthopedic surgeons in clinical settings. Monoblock components require bone cement; modular components may be cemented or uncemented (TM/porous posts). Provides stable glenoid surface for shoulder joint articulation; restores joint function; addresses degenerative disease or fracture. Surgeon selects appropriate size/configuration based on patient anatomy.

Clinical Evidence

No clinical data provided. Evidence is based on non-clinical bench testing including accelerated corrosion, fatigue of modular connection, glenoid loosening (rocking horse), range of motion, wear analysis, porous structure characterization, and MR evaluation.

Technological Characteristics

Glenoid prosthesis; materials include polyethylene, Tivanium, Trabecular Metal (TM), and Porous Plasma Spray (PPS). Standards: ASTM F2028 (corrosion, fatigue, loosening), ASTM F1378 (ROM, wear), ASTM 1854/F1160/F1044/F1147/F1978 (porous structure), ASTM F2119/F2052/F2182 (MR evaluation). Modular and monoblock configurations. Cemented or uncemented application.

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 problems where other treatments are inadequate. May be used in revision procedures when 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

• Modular Hybrid Glenoid (K060694)
• Bio-Modular Shoulder System - Pegged Glenoid (K030710)

Reference Devices

• Solar 2 Anatomic Shoulder (K040432)
• Comprehensive Augmented Glenoid (K172502)
• Trabecular Metal Glenoid (K071090)
• Bigliani/Flatow Glenoid (K030710)

Submission Summary (Full Text)

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October 23, 2019

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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Zimmer Inc. Patricia Sandborn Beres Regulatory Affairs Principal P.O. Box 708 Warsaw, Indiana 46581-0708

# Re: K191814

Trade/Device Name: Alliance 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: September 20, 2019 Received: September 23, 2019

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 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

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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 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 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) K191814

Device Name Alliance 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. Difficuit 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.

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 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: | October 21, 2019 |
| Subject Device: | Trade Name: Alliance Glenoid<br>Common Name: Anatomic Glenoid Prosthesis<br>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 | Modular Hybrid Glenoid | Biomet | K060694 |
| Secondary Predicate | Bio-Modular Shoulder<br>System - Pegged Glenoid | Biomet | K030710 |
| Reference Predicates | | | |
| Reference Predicate for<br>2-Pegged Glenoid | Solar 2 Anatomic Shoulder | Stryker | K040432 |
| Reference Predicate for<br>PPS Coating | Comprehensive<br>Augmented Glenoid | Biomet | K172502 |
| Reference Predicate for<br>TM material | Trabecular Metal Glenoid | Zimmer | K071090 |
| Reference Predicate for<br>testing | Bigliani/Flatow Glenoid | Zimmer | K030710 |

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# Purpose and Device Description:

The Alliance Glenoid is a series of glenoid components which includes monoblock polyethylene glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs glenoids. All glenoid types are available in various sizes. The central posts of the modular 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.
- 2. Rheumatoid arthritis.
- Correction of functional deformity. 3.
- Fractures of the proximal humerus, where other 4. 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.

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

- Intended Use: Identical 0
- 0 Indications for Use: Similar - surgeon may opt to use the primary implants in a revision surgery
- 0 Materials: All materials have previously been used for shoulder glenoid replacement components

# Intended Use and Indications for Use:

# Summary of Technological Characteristics:

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- Design Features: Similar to predicates ●
- . Sterilization: Identical to predicate

Summarv of Performance Data (Nonclinical and/or Clinical)

#### Non-Clinical Tests: .

- O Accelerated Corrosion (ASTM F2028)
- Fatigue of Modular Connection (ASTM F2028) O
- o Glenoid Loosening (Rocking Horse) (ASTM F2028)
- Range of Motion (ROM) (ASTM F1378) O
- Wear Analysis (ASTM F1378) o
- o Porous Structure Characterization - TM (ASTM 1854)
- Porous Structure Characterization PPS (ASTM o 1854, ASTM F1160, ASTM F1044, ASTM F1147, ASTM F1978)
- MR Evaluation (ASTM F2119, ASTM F2052, o ASTM F2182)
- Clinical Tests: ●
- None provided o

Substantial Equivalence Conclusion

The proposed Alliance 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