When used in the Humelock II Reversible Shoulder System: The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

When used in the Humelock Reversed Shoulder System:

The Humelock Reversed Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

During primary or revision surgery, if the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or the glenoid bone fractures during the procedure, a taper adapter can be used to convert the Humelock Reversed Shoulder to an anatomic hemi-shoulder prosthesis.

The humeral stem of the Humelock Reversed Cemented Shoulder Prothesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prothesis is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotational spoiler can be used with either the cementless or the cemented stems.

The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

When used in the Humeris Shoulder System:

In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The glenoid components of the Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

Device Description

The Glenoid Baseplate with Screw is a new component added to the Humelock II® Reversible Shoulder System, Humelock Reversed® Shoulder System, and Humeris® Shoulder System, when used for a reverse shoulder construct. Compatible components for use with the Glenoid Baseplate with Screw are the same as those previously cleared compatible components for use as a component in the primary predicate device, K150488, K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.

AI/ML Overview

This FDA 510(k) clearance document for the "Glenoid Baseplate with Screw" does not describe a study that involves software, AI, or human readers, or that uses acceptance criteria based on metrics like sensitivity, specificity, or AUC.

Instead, this document is for a medical device (a shoulder implant component). The "acceptance criteria" and "device performance" discussed relate to mechanical testing of the implant, not diagnostic or predictive performance.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, because this type of information is simply not present in this document.

Here's what I can extract related to the mentioned "acceptance criteria" which is limited to mechanical performance:

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

Acceptance Criteria	Reported Device Performance
Torque properties per ISO 6475-1	Results demonstrated "greater than the acceptance criteria per the standard."

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 for Test Set: Not specified. Standard mechanical testing typically uses a specific number of samples for each test, but the exact number is not detailed here.
Data Provenance: Not explicitly stated, but the manufacturer is FX Solutions in Viriat, France (01440). It's reasonable to infer the testing was conducted by or for the manufacturer, potentially in France or a certified testing facility elsewhere. The testing is non-clinical, meaning it's conducted in a lab setting, not on patient data.

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):

Not applicable. "Ground truth" in this context would refer to the mechanical properties of the device as defined by a standard. Experts are typically involved in setting the standard and performing the tests, but no specific number or qualifications are mentioned as this isn't a diagnostic performance study.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical testing of a physical device.

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, an MRMC study was not done. This document is for a physical medical implant, not an AI device or software.

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

Not applicable. This document is for a physical medical implant, not an algorithm.

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

The "ground truth" for the device's mechanical performance is based on the specifications outlined in the ISO 6475-1 standard for torque properties.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

FX Shoulder USA, Inc. Kathy Trier VP Regulatory, Quality, Clinical, Compliance 13465 Midway Road, Suite 101 Dallas, Texas 75244

Re: K192799

Trade/Device Name: Glenoid Baseplate with Screw Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: January 17, 2020 Received: January 21, 2019

Dear Kathy Trier:

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

February 21, 2020

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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/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 mediation-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,

FOR 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) K192799

Device Name Glenoid Baseplate with Screw

Indications for Use (Describe)

When used in the Humelock II Reversible Shoulder System:

The Humelock II Reversible Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

When used in the Humelock Reversed Shoulder System:

The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

When used in the Humeris Shoulder System:

In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

In a reverse shoulder configuration, the Humeris Shoulder is indicated for primary or revision total shoulder athroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear.

The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

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The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only. The Humeris Shoulder System are intended for cemented use only. The glenoid baseplate component is intended for cementless use with the addition of screws for fixation.

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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7. 510(k) Summary

Applicant/Sponsor:	FX Shoulder USA, Inc.13465 Midway Road, Suite 101Dallas, Texas 75244Establishment Registration No: 3014128390
Manufacturer:	FX Solutions1663 Rue de MajornasViriat, France 01440Establishment Registration No: 3009532798
Contact Person:	Kathy Trier, Ph.D.VP Regulatory, Quality, Clinical, Compliance
Date:	February 20, 2020
Proprietary Name:	Glenoid Baseplate with Screw
Common Name:	Reverse Shoulder Prosthesis
Product Code(s):	PHX, HSD
Classification Name:	21 CFR 888.3660: shoulder joint metal/polymersemi-constrained cemented prosthesis - Class II21 CFR 888.3690 shoulder joint glenoid (hemi-shoulder) metallic uncemented prosthesis - Class II
Substantially EquivalentDevices:	Primary Predicate:Humelock II Reversible Shoulder System (K150488)Humelock Reversed Shoulder System (K162455)Humeris Shoulder System (K163669)

Device Description

The Glenoid Baseplate with Screw is a new component added to the Humelock II® Reversible Shoulder System, Humelock Reversed® Shoulder System, and Humeris®

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Shoulder System, when used for a reverse shoulder construct. Compatible components for use with the Glenoid Baseplate with Screw are the same as those previously cleared compatible components for use as a component in the primary predicate device, K150488, K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder System, when used for a reverse shoulder construct.

Intended Use / Indications

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stems are intended for cemented or cementless use. The metaglene baseplate is intended for cementless use with the addition of screws for fixation.

When used in the Humelock Reversed Shoulder System:

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate and post extension are intended for cementless use with the addition of screws for fixation.

When used in the Humeris Shoulder System:

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In an anatomic shoulder configuration, the Humeris Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:

A severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis;
Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Summary of Technologies / Substantial Equivalence

The new component, Glenoid Baseplate with Screw, is substantially equivalent to the primary predicate in that it is identical to the primary predicate on indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components. The subject device is a design modification of the primary predicate that does not raise new questions of safety and effectiveness and is substantially equivalent to the primary predicate.

Non-Clinical Testing

Mechanical testing included torque properties of the worst case Central Screw in accordance with ISO 6475-1 and demonstrated results greater than the acceptance criteria per the standard.

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence of the Glenoid Baseplate with Screw to the predicate devices.

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Summary

Based upon the assessment of substantial equivalence regarding the indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, and the nonclinical testing and assessment of the risk associated with the design modification of the primary predicate submitted here, the Glenoid Baseplate with Screw is expected to be as safe, as effective, and perform as well as the legally marketed device predicate.

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.”