Biomet Comprehensive Reverse Shoulder products are 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.

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.

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 intents 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.

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

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.

The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy*

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada

Anatomic Applications

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate.

Reverse Applications
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.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications 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 application. Huments with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Biomet Comprehensive Reverse Shoulder products are in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy 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 fixations. 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

Comprehensive Shoulder System consists of partial and total shoulder replacement components use in cemented and uncemented applications. The devices are modular components consisting of humeral stems, modular heads and glenoid components for anatomic and humeral tray and glenosphere components for reverse configuration. The purpose of the current submission is to add MR Conditional labeling.

AI/ML Overview

Here's an analysis of the provided information, addressing your questions about acceptance criteria and study details.

Important Note: The provided document is a 510(k) FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, much of the information you've requested regarding specific acceptance criteria, performance metrics, ground truth, and human reader studies is not present in this type of document because it is not required for a 510(k) submission for this type of device (implants). The "acceptance criteria" here implicitly refer to the device not posing new questions of safety or effectiveness compared to its predicates and meeting established standards for its material properties and MR compatibility.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a shoulder replacement system seeking to add "MR Conditional" labeling, the "acceptance criteria" are related to established safety and performance standards for implants, particularly concerning their interaction with Magnetic Resonance (MR) environments. The performance data provided is entirely non-clinical and related to MR compatibility.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Non-Clinical Tests)
Material Properties & Design: Similar to predicate devices, ensuring established biocompatibility, mechanical strength, and functional design.	- Intended Use: Identical to predicate. - Indications for Use: Identical to predicate. - Materials: Identical to predicate. - Design Features: Identical to predicate. - Sterilization: Identical to predicate.
MR Compatibility: The device should not pose an unacceptable risk or generate excessive artifacts in an MR environment and should meet established standards for MR Conditional labeling.	- ASTM F2503-20 (Labeling): Evaluation completed (implies compliance for labeling). - ASTM F2119-07R13 (Artifact): Evaluation completed (implies acceptable artifact levels). - ASTM F2213-17 (Torque): Evaluation completed (implies acceptable torque in MR environment). - ASTM F2052-21 (Displacement Force): Evaluation completed (implies acceptable displacement force in MR environment). - ASTM F2182-19E02 (RF-heating): Evaluation completed (implies acceptable RF-heating). - Preliminary Phantom Evaluation: Completed.

Acceptance Criteria (Implicit)

Reported Device Performance (Non-Clinical Tests)

Material Properties & Design: Similar to predicate devices, ensuring established biocompatibility, mechanical strength, and functional design.

- Intended Use: Identical to predicate. - Indications for Use: Identical to predicate. - Materials: Identical to predicate. - Design Features: Identical to predicate. - Sterilization: Identical to predicate.

MR Compatibility: The device should not pose an unacceptable risk or generate excessive artifacts in an MR environment and should meet established standards for MR Conditional labeling.

- ASTM F2503-20 (Labeling): Evaluation completed (implies compliance for labeling). - ASTM F2119-07R13 (Artifact): Evaluation completed (implies acceptable artifact levels). - ASTM F2213-17 (Torque): Evaluation completed (implies acceptable torque in MR environment). - ASTM F2052-21 (Displacement Force): Evaluation completed (implies acceptable displacement force in MR environment). - ASTM F2182-19E02 (RF-heating): Evaluation completed (implies acceptable RF-heating). - Preliminary Phantom Evaluation: Completed.

Study Details

As this is a 510(k) for a medical implant and not an AI/software device, many of the requested categories related to diagnostic performance or human reading studies are not applicable.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of diagnostic data. For the non-clinical MR compatibility tests, the "sample size" would refer to the number of device components tested according to the referenced ASTM standards. This specific number is not provided in the summary but would be detailed in the full test reports.
- Data Provenance: Not applicable for diagnostic data. The MR compatibility tests are conducted in a controlled laboratory setting (likely in the US, where the company is based), not on patient data.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth, in the AI/diagnostic context, refers to definitively established diagnoses or classifications. For an implant, "ground truth" relates to material science and engineering principles verified by standard testing methods and accredited labs.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are used to resolve discrepancies among expert opinions in diagnostic studies.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI systems, not for physical implants.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study in the AI sense was not done. The "performance" here is for the physical device's interaction with an MR field, which isn't an "algorithm-only" performance.
Type of Ground Truth Used:
- For the core claims of equivalence (materials, design, etc.), the "ground truth" is established engineering and scientific principles, validated by testing against relevant ASTM standards and by comparison to the predicate devices. For MR compatibility specifically, the ground truth is defined by the objective measurements obtained through the standard ASTM test procedures (e.g., measured temperature rise, displacement force, artifact size) and compared against the limits established by those standards to determine "MR Conditional" status.
Sample Size for the Training Set:
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.

Summary

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March 15, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two distinct elements: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized depiction of a human figure, while the FDA portion includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Biomet Manufacturing Corp. Aishwarya Pandey Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46582

Re: K214001

Trade/Device Name: Comprehensive® Shoulder System, 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, MBF, HSD Dated: December 14, 2021 Received: December 21, 2021

Dear Aishwarya Pandey:

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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Farzana Farzana Sharmin -S Sharmin -S Date: 2023.03.15

For Jiping Chen, MD, Ph.D., M.P.H. Division 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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510(k) Number (if known) K214001

Device Name

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Biomet® Comprehensive® Reverse Shoulder Screws)

Indications for Use (Describe)

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)

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

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K214001

Device Name

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Biomet® Comprehensive® Reverse Shoulder Products)

Indications for Use (Describe)

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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K214001

Device Name

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Biomet® Shoulder Joint Replacement Prostheses)

Indications for Use (Describe)

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

Difficult clinical management problems, including cuff arthropathy, 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.

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K214001

Device Name

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Biomet® Comprehensive® Convertible Glenoid Prostheses)

Indications for Use (Describe)

Anatomic Applications

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

1. Rheumatoid arthritis.

Revision where other devices or treatments have failed.

1. Correction of functional deformity.

Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may be suitable or may be inadequate.

Reverse Applications

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.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K214001

Device Name

Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Comprehensive® RSA Baseplates)

Indications for Use (Describe)

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.

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 ether 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

{9}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Aishwarya PandeyRegulatory Affairs SpecialistTelephone: 574.373.3740Fax: +1(574)-373-3740
Date:	March 15, 2023
Subject Device:	Trade Name: Comprehensive® Shoulder System, Comprehensive®Reverse Shoulder SystemCommon Name: Shoulder replacement prosthesis
	Classification Name:PHX - Shoulder Prosthesis, Reverse Configuration (21 CFR 888.3660) KWS - Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis (21 CFR 888.3660) PAO - Shoulder joint metal/polymer (+additive) semi-constrained cemented prosthesis (21 CFR 888.3660) KWT - Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR 888.3650) MBF - Shoulder joint metal/polymer/metal Nonconstrained or semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3670) HSD - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis (21 CFR 888.3690)

Predicate Device(s):

Primary Predicate	510(k) Number
Comprehensive Primary Shoulder	K193038
Comprehensive Reverse Shoulder System	K193373
Comprehensive Augmented Baseplates	K172502
Comprehensive Convertible Glenoid	K211729

Device Description

Indications for Use:

Biomet Comprehensive Reverse Shoulder Screws- IFU 01-50-0890

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy failed shoulder joint

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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.

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.

Biomet® Comprehensive® Reverse Shoulder Products- IFU 01-50-0903

Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy 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.

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.

Biomet® Shoulder Joint Replacement Prostheses- IFU 01-50-0944

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, including cuff arthropathy, 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.

Humeral components with a porous coated surface coating are indicated for either cemented biological fixation applications.

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The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.

*The Titanium Versa-Dial Humeral Head Prosthesis is not for sale in Canada.

Biomet® Comprehensive® Convertible Glenoid Prostheses- IFU 01-50-1256

Anatomic Applications

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.
1. Rheumatoid arthritis.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 5.
Difficult clinical management problems, including cuff arthropathy, where other methods of 6. treatment may not be suitable or may be inadequate.

Reverse Applications

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications 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 application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Comprehensive Augmented Glenoid Components. Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (aka Comprehensive® RSA Baseplates)- IFU 01-50-1284

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.

{13}------------------------------------------------

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 predicate ●
Indications for Use: Identical to predicate ●
Materials: Identical to predicate ●
Design Features: Identical to predicate
Sterilization: Identical to predicate ●

Summary of Performance Data

(Nonclinical and/or Clinical)

Non-Clinical Tests:
- o Evaluation of MR compatibility to support MR Conditional labeling
  - ASTM F2503-20 (Labeling) o
  - ASTM F2119-07R13 (Artifact) O
  - O ASTM F2213-17 (Torque)
  - ASTM F2052-21 (Displacement Force) O
  - ASTM F2182-19E02 (RF-heating) Preliminary Phantom O Evaluation
Clinical Tests: ●
- o None provided

Substantial Equivalence

Conclusion

Based on the information contained within this submission, it is concluded that the Comprehensive Shoulder System is substantially equivalent to the identified predicate device.

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.”