These devices are intended for shoulder joint arthroplasty.
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 Description

The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Biomet Comprehensive® Reverse Shoulder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or explicitly stated in this document in the way it would be for a de novo submission or a product with novel technology requiring extensive clinical trials to establish safety and effectiveness.

However, based on the non-clinical tests described, we can infer the acceptance criteria and the "study" (non-clinical testing) that supports the device's performance relative to these criteria.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Non-Clinical Tests)	Reported Device Performance
Fatigue Strength: Maintain structural integrity under a clinically relevant load without fracture or failure. (Specifically, withstand 566N for 5 million cycles).	The humeral bearing and tray construct could withstand a fatigue load of 566N for 5 million cycles. The testing demonstrated that the modifications did not adversely impact the fatigue strength.
Range of Motion (ROM): Conformance to ASTM F1378-12.	Range of Motion analysis provides verification of the Range of Motion (ROM) conformance to ASTM F1378-12.
Wear Rate (Titanium Glenospheres): Inferior to Cobalt Alloy glenospheres.	Not an acceptance criterion for improvement, but a known characteristic: "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." This is a caution for clinical use rather than a performance target.
Biocompatibility of Materials: (Inferred by "Materials: Identical to predicate.")**	Materials are identical to predicate, implying acceptable biocompatibility as previously established for the predicate.

Information not available or not applicable based on the provided document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for the fatigue strength or ROM testing. Non-clinical mechanical tests typically use a smaller number of samples sufficient to demonstrate statistical significance or meet a deterministic threshold.
Data Provenance: The fatigue testing was "performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN)". This indicates a U.S.-based, internal laboratory setting for the non-clinical tests. The tests themselves are prospective for the specific design changes.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical data requiring expert ground truth establishment. The "ground truth" for these tests is the physical performance under controlled conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective data interpretation, not for objective mechanical performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. This is a mechanical implant, not an AI-powered diagnostic device. The document explicitly states "Clinical Tests: None provided."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as it pertains to AI/software performance. The device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests: The "ground truth" is defined by the physical and mechanical properties of the device as measured under controlled laboratory conditions, against established engineering standards (e.g., ASTM F1378-12) and internal test requirements. It's an objective measurement of material and design performance.
For the overall submission: The primary "ground truth" or basis for clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones.

8. The sample size for the training set

This question is not applicable as the document describes a mechanical implant, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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April 15, 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 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 Inc. Kari Hovorka Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 WARSAW, IN 46581

Re: K193373

Trade/Device Name: Comprehensive® Reverse Shoulder Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: March 17, 2020 Received: March 18, 2020

Dear Kari Hovorka:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K193373

Device Name Comprehensive® Reverse Shoulder

Indications for Use (Describe) (IFU 01-50-0903 Biomet® Comprehensive® Reverse Shoulder Products)

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 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.

(IFU 01-50-0890 Biomet® Comprehensive® Reverse Shoulder Screws)

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.

Type of Use (Select one or both, as applicable)

X 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 Comprehensive Reverse Shoulder 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 September 13, 2019.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Primary Contact Person:	Kari HovorkaRegulatory Affairs SpecialistTelephone: (877.652.0830)
Secondary Contact Person:	Jared CooperRegulatory Affairs ManagerTelephone: (574-372-1941)
Date:	December 2, 2019
Subject Device:	Trade Name: Comprehensive® Reverse ShoulderCommon Name: Shoulder Prosthesis,Reverse ConfigurationClassification Name:Shoulder joint metal/polymer semi-constrained cemented prosthesisPHX – Shoulder Prosthesis, Reverse Configuration (21 CFR 888.3660) KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (21 CFR 888.3660)

Predicate Device(s):

Predicates	510(k) Number
Comprehensive Reverse Shoulder	K080642 -Primary
Comprehensive Reverse Shoulder – Humeral Trays	K113069
Comprehensive Reverse Shoulder – E1 (Poly) Humeral Bearings	K113121
Comprehensive Reverse Shoulder – Mini Baseplate	K120121
Comprehensive Reverse Shoulder – Titanium Glenospheres	K131353

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Comprehensive Reverse Shoulder – Screws	K132239
Comprehensive Vault Reconstruction System (VRS)	K152754

Purpose and DeviceDescription:	The purpose of this submission is:To provide a cumulative assessment of design changes madeto the system since original clearance; The subject Glenosphere devices introduce a modifiedinner surface finish and a pilot hole modification; The subject Humeral Tray and the Humeral Bearingdevices introduced dimensional modifications; To document previously cleared (K152754) compatibilitybetween the Comprehensive® Reverse Shoulder and theTrabecular Metal™ Reverse Shoulder; To update labeling in order to bring the Instructions for Useup to current practices; To insure that the all of the instrumentation/accessories foruse with this system are appropriately associated with a510(k).
	Device Description:The Comprehensive® Reverse Shoulder (CRS) is a total shoulderreplacement system in a reverse configuration. The CRS wasdesigned to provide a complete, seamless system based on theComprehensive Shoulder platform by avoiding the need toremove a well-fixed humeral stem associated with a prioranatomical shoulder arthroplasty for conversion to reverseshoulder arthroplasty. This is made possible because the CRS canutilize any of the existing Comprehensive stems, includingprimary, revision, or fracture stems in cemented or uncementedapplications. The CRS performs its function by replacing thedamaged or diseased articular surfaces of the native shoulder withartificial surfaces with the intent to improve shoulder functionand/or reduce shoulder pain.
Intended Use andIndications for Use:	These devices are intended for shoulder joint arthroplasty.(IFU 01-50-0903 Biomet® Comprehensive® Reverse ShoulderProducts)Biomet Comprehensive Reverse Shoulder products are indicatedfor use in patients whose shoulder joint has a grossly deficientrotator cuff with severe arthropathy and/or previously failedshoulder joint replacement with a grossly deficient rotator cuff.

Purpose and DeviceDescription:

The purpose of this submission is:To provide a cumulative assessment of design changes madeto the system since original clearance; The subject Glenosphere devices introduce a modifiedinner surface finish and a pilot hole modification; The subject Humeral Tray and the Humeral Bearingdevices introduced dimensional modifications; To document previously cleared (K152754) compatibilitybetween the Comprehensive® Reverse Shoulder and theTrabecular Metal™ Reverse Shoulder; To update labeling in order to bring the Instructions for Useup to current practices; To insure that the all of the instrumentation/accessories foruse with this system are appropriately associated with a510(k).

Device Description:The Comprehensive® Reverse Shoulder (CRS) is a total shoulderreplacement system in a reverse configuration. The CRS wasdesigned to provide a complete, seamless system based on theComprehensive Shoulder platform by avoiding the need toremove a well-fixed humeral stem associated with a prioranatomical shoulder arthroplasty for conversion to reverseshoulder arthroplasty. This is made possible because the CRS canutilize any of the existing Comprehensive stems, includingprimary, revision, or fracture stems in cemented or uncementedapplications. The CRS performs its function by replacing thedamaged or diseased articular surfaces of the native shoulder withartificial surfaces with the intent to improve shoulder functionand/or reduce shoulder pain.

Intended Use andIndications for Use:

These devices are intended for shoulder joint arthroplasty.(IFU 01-50-0903 Biomet® Comprehensive® Reverse ShoulderProducts)Biomet Comprehensive Reverse Shoulder products are indicatedfor use in patients whose shoulder joint has a grossly deficientrotator cuff with severe arthropathy and/or previously failedshoulder joint replacement with a grossly deficient rotator cuff.

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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.

(IFU 01-50-0890 Biomet® Comprehensive® Reverse Shoulder Screws)

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.

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

Intended Use: Identical to predicate ●
. Indications for Use: Similar to predicate: the subject devices have similar indications as compared to the predicate devices. The modifications to the indications does not alter the safety or efficacy of the subject devices. The change is not a result of safety or performance issues nor is the intent to significantly improve safety to efficacy. No new risks result from the change in indications wording.
Materials: Identical to predicate.
Design Features: Similar to predicate; the design changes . made to the subject Comprehensive Reverse Shoulder device include addition of a 30-grit blast finish process to the inner surface of the glenosphere components, diameter reduction of the pilot hole of glenosphere components, refinement of tolerance band of the fillet between the taper and base of the tray, and narrowing of the interior notch width of the humeral bearings.
Sterilization: Similar to predicate; ArComXL Humeral Bearings devices were cleared to be sterilized with either EtO or Gas Plasma sterilization in K080642. Subject ArComXL Humeral Bearings devices are provided sterile by Gas Plasma, with no changes to the sterilization parameters as cleared in K080642. The remaining subject components have identical sterilization parameters to predicate devices.

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

Non-Clinical Tests:

Fatigue Strength Testing was completed to demonstrate ● that the modifications do not adversely impact the fatigue strength of the Comprehensive trays and humeral constructs under a clinically motivated unconstrained fixture conditions. The test method noted in the previous testing submitted with K113069, Comprehensive Reverse Humeral Tray Medium Fatigue Strength Determination, and the test report presented in this submission are sufficiently different such that the test results cannot be directly compared. Fatigue testing was performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN) to demonstrate that the Humeral bearing

Summary of Technological Characteristics:

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and tray construct could withstand a fatigue load of 566N for 5 million cycles. Zimmer Biomet established a laboratory fatigue test method and requirement for shoulder implant

system based on extensive literature review as described in the test report.

. Range of Motion analysis provides verification of the Range of Motion (ROM) conformance to ASTM F1378-12.

Clinical Tests:

None provided .

Substantial Equivalence Conclusion:

The subject Comprehensive Reverse Shoulder has the same intended use and similar indications for use as the subject devices. The subject devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that:

any differences do not raise new questions of safety and effectiveness; and
the subject devices are at least as safe and effective as the legally marketed predicate devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
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).(b)
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.”