Comprehensive Reverse Shoulder System

K181611 · Biomet Manufacturing Corp · PHX · Sep 24, 2018 · Orthopedic

Device Facts

• Record ID: K181611
• Device Name: Comprehensive Reverse Shoulder System
• Applicant: Biomet Manufacturing Corp
• Product Code: PHX · Orthopedic
• Decision Date: Sep 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Comprehensive Reverse Shoulder products are indicated for use 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 coating are indicated for either cemented or uncemented biological fixation applications.

Device Story

Comprehensive Reverse Shoulder System is a line extension of existing shoulder arthroplasty implants. System includes new 36mm and 40mm tray and liner locking mechanisms and a 40mm glenosphere. Components are implanted by orthopedic surgeons in a clinical/OR setting to replace the shoulder joint. Device restores joint function in patients with rotator cuff deficiency. Surgeons select components based on patient anatomy and material sensitivity (e.g., Titanium vs. Cobalt Alloy). Output is a reconstructed shoulder joint providing pain relief and improved mobility. System utilizes established materials (Ti-6AL-4V, Co-28Cr-6Mo, and highly cross-linked polyethylene) and surgical techniques consistent with predicate devices.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical bench testing, including assembly force, locking mechanism fatigue, tray fatigue, liner torque-out, taper strength, finite element analysis (FEA), range of motion (ROM) analysis, and wear rationale.

Technological Characteristics

Materials: Ti-6AL-4V, Co-28Cr-6Mo, and highly cross-linked ultrahigh molecular weight polyethylene (Prolong/Vivacit-E). Features: 36mm/40mm tray and liner locking mechanisms, 40mm glenosphere, centric and offset (+3, +6) tapers. Fixation: Porous coating, Hydroxyapatite (HA) coating, or cemented options. Sterilization: Identical to predicate. No software or electronic components.

Indications for Use

Indicated for patients with grossly deficient rotator cuff, severe arthropathy, or failed shoulder joint replacement. Requires anatomically/structurally suitable anatomy and functional deltoid muscle. Indicated for primary, fracture, or revision total shoulder replacement for pain relief and disability due to gross rotator cuff deficiency. 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 Humeral Shoulder Tray (K113069)
• Comprehensive Reverse Shoulder - Titanium Glenosphere (K131353)
• Trabecular Metal Reverse Shoulder System, Vivacit-E® Vitamin E Highly Crosslinked Polyethylene Liners (K133378)

Reference Devices

• Comprehensive Reverse System (K080642)
• Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components (K013991)

Submission Summary (Full Text)

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March 27, 2019

Zimmer, Inc. Dalene Binkley Regulatory Affairs Project Manager 345 East Main Street Warsaw, Indiana 46580

Re: K181611

Trade/Device Name: Comprehensive Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, PAO, KWT Dated: August 23, 2018 Received: August 24, 2018

Dear Dalene Binkley:

This letter corrects our substantially equivalent letter of September 24, 2018.

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.

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

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

510(k) Number (if known)

### K181611

Device Name Comprehensive Reverse Shoulder System

#### Indications for Use (Describe)

Comprehensive Reverse Shoulder products are indicated for use 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 coating are indicated for either cemented or uncemented biological fixation applications.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |

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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 Comprehensive Reverse Shoulder System 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>345 East Main Street<br>Warsaw, IN 46580<br>Establishment Registration Number: 1822565 | | |
|----------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Contact Person: | Dalene Binkley<br>Regulatory Affairs Project Manager<br>Telephone: [phone]<br>Fax: [phone] | | |
| Date: | June 18, 2018 | | |
| Subject Device: | | Trade Name: Comprehensive Reverse Shoulder System | |
| | | Common Name: Shoulder Prosthesis, Reverse<br>Configuration | |
| | | Classification Name: | |
| | | • PHX- Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis (21 CFR 888.3660) | |
| | | • KWS - Shoulder joint metal/polymer semi-constrained<br>cemented prosthesis (21 CFR 888.3660) | |
| | | • PAO - Shoulder joint metal/polymer (+additive) semi-<br>constrained cemented prosthesis (21 CFR 888.3360) | |
| | | • KWT - Shoulder joint, metal/polymer, non-constrained,<br>cemented prosthesis (21 CFR 888.3650) | |
| Predicate Device(s): | K113069<br>(Primary)<br>K131353 | Comprehensive Reverse<br>Humeral Shoulder Tray<br>Comprehensive Reverse<br>Shoulder - Titanium<br>Glenosphere | Biomet<br>Manufacturing Corp<br>Biomet<br>Manufacturing Corp |
| | K133378 | Trabecular Metal Reverse<br>Shoulder System, Vivacit-E®<br>Vitamin E Highly Crosslinked<br>Polyethylene Liners | Zimmer, Inc. |

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| Reference Devices: | | |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| K080642 | Comprehensive Reverse System | Biomet Manufacturing Corp |
| K013991 | Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components | Zimmer, Inc. |
| Purpose and Device Description: | The purpose of this submission is to include newly designed trays, liners and a glenosphere into the Comprehensive Reverse Shoulder System.<br><br>The devices are a line extension of the Comprehensive Reverse Shoulder System and consists of new 36mm and 40mm tray and liner locking mechanism designs as well a a new 40mm glenosphere. The highly cross-linked ultrahigh molecular weight (HXPE) polyethylene liners are offered either in Prolong® (Standard) or Vivacit-E (Vitamin E). The tray taper geometry as well as the material (Ti-6AL-4V and Co-28Cr-6Mo) and thickness offerings are identical (standard, +5mm, +10mm) to the predicate. The trays will still be offered with a centric (standard) taper as well as two other offset tapers (+3 and +6) to provide more offerings to the surgeon. | |
| Intended Use and Indications for Use: | 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.<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 | |

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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.

# 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: The polyethylene liners (Prolong and ● Vivacit-E), Co-Cr-Mo and Titanium trays and glenospheres are identical to those predicates currently marketed.
- Design Features: The design features of the subject device are similar to those predicates currently marketed. The design differences have not identified any issues that would impact the safety and efficacy of the devices.
- . Sterilization: Identical assurance level and validation methods to the primary predicate.

# Summary of Performance Data (Nonclinical and/or Clinical)

Non-clinical testing demonstrated that the proposed devices meets performance requirements as defined by Design Control activities and is substantially equivalent to the predicate device in terms of safety and efficacy.

- Non-Clinical Tests: ●
- o Assembly Force
- Locking Mechanism Fatigue O
- Tray Fatigue O
- Tray and Liner Fatigue O
- Liner Torque-Out O
- Taper Strength O
- Finite Element Analysis (FEA) O

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- Range of Motion (ROM) O
- Wear Rationale O
- MRI Conditional O
- Clinical Tests: Clinical data and conclusions were not ● needed for this device.

### Substantial Equivalence Conclusion

The proposed devices are line extensions to the predicate devices. They share the same indications for use/intended use, utilize the same materials and manufacturing processes, and have similar technical features as their predicates. No new issues of safety and efficacy have been raised.