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 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 Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless or 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 and Humeris 135 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 baseplate component is intended for cementless use with addition of screws for fixation.

When used in the FX V135 Shoulder Prosthesis:

In an anatomic shoulder configuration, the FX V135 Shoulder Prosthesis 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 FX V135 Shoulder Prosthesis 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 FX V135 Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135 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 Full Wedge Lateralized and Augmented Baseplates are new components added to the reverse shoulder replacement systems including the Humelock II Reversible Shoulder System, the Reversed (K162455), the Humeris Shoulder (K163669, K222936) and the FX V135 Shoulder Prosthesis (K213117, K223801). The Lateralized baseplate with full wedge augmentation is a modification of the primary predicate half wedge lateralized and augmented baseplates (K210790) and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.

Compatible components for use with the Full Wedge Lateralized and Augmented Baseplates are the same as the compatible components for use in the previously cleared reverse shoulder replacement systems.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding orthopedic implants, specifically shoulder joint prostheses. It details the device's indications for use, its classification, and a summary of the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

The request asks for information about the acceptance criteria and a study that proves the device meets these criteria, focusing on aspects typically found in studies for AI/software-driven medical devices. However, this document is for a mechanical orthopedic implant (shoulder baseplates), not an AI or software-driven device. Therefore, many of the requested categories (e.g., number of experts for ground truth, MRMC study, training set ground truth, effect size for human readers) are not applicable to this type of medical device submission.

The "study" in this context refers to non-clinical bench testing to demonstrate mechanical performance, not a study evaluating diagnostic performance of an AI algorithm.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (from testing standards)	Reported Device Performance
Glenoid loosening performance (as per ASTM F2028-17) meets or exceeds predicate.	Found to be substantially equivalent to the primary predicate.
Range of motion analysis meets or exceeds predicate and ASTM F-1378-18.	Demonstrates substantial equivalence as well as exceeding ASTM F-1378-18.

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated for bench testing, but these typically involve a set number of test samples (e.g., 6-12) based on the specific ASTM standard. The document only mentions "bench testing for glenoid loosening" and "range of motion analysis."
Data provenance: Not applicable in the sense of patient data. This is mechanical testing done in a lab setting. It is not specified if the testing was performed in the US or another country, but the manufacturer is based in France.
Retrospective/Prospective: Not applicable for mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth for mechanical testing is established by engineering specifications and standards (e.g., ASTM). No human experts are used in this context to establish a "ground truth" for diagnostic accuracy.

4. Adjudication method for the test set:

Not Applicable. This concept applies to human interpretation of data, typically in diagnostic studies. For mechanical testing, the results are quantitative measurements against predefined criteria.

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:

Not Applicable. This is not an AI/software device. No human reader studies were performed.

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

Not Applicable. This is not an AI/software device.

7. The type of ground truth used:

For mechanical properties: Established by standardized engineering tests and measurements (e.g., ASTM F2028-17 for glenoid loosening, ASTM F-1378-18 for range of motion). These standards define the methodology and acceptable ranges for performance.

8. The sample size for the training set:

Not Applicable. This refers to AI model training data. This document is about a physical implant device, not an AI or software device.

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

Not Applicable. (See point 8)

Summary of Device Performance and Substantial Equivalence:

The document states that the Full Wedge Lateralized and Augmented Baseplates are a modification of previously cleared predicate devices. Substantial equivalence for this device was demonstrated through:

Non-Clinical Testing:
- Bench testing for glenoid loosening (ASTM F2028-17) showed the device is substantially equivalent to the primary predicate.
- Range of motion analysis, based on the same parameters and assumptions as the predicate, demonstrated substantial equivalence and exceeded ASTM F-1378-18.
Comparison to Predicate Device: The new components are "identical to the primary predicate, half wedge lateralized augmented baseplates, on indications, material, manufacturing, packaging, single use, sterilization, shelf life, biocompatibility, compatible components."

Conclusion: The FDA cleared this device based on non-clinical engineering bench testing that confirmed the modified design performed equivalently to, or better than, the predicate device according to established industry standards. Clinical testing was deemed unnecessary as the changes did not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

FX Shoulder USA, Inc. Cory Trier RA/Compliance Associate 15920 Addison Road. Suite 200 Addison, Texas 75001

Re: K240278

Trade/Device Name: Full Wedge Lateralized and Augmented Baseplates 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: April 9, 2024 Received: April 9, 2024

Dear Cory 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

May 15, 2024

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Farzana

Sharmin -S

Digitally signed by Farzana Sharmin -S
Date: 2024.05.15 10:44:13 -04'00'

Farzana Sharmin, Ph.D. 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

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Indications for Us

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240278

Device Name

Full Wedge Lateralized and Augmented Baseplates

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

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).

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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.

When used in the FX V135 Shoulder Prosthesis:

In an anatomic shoulder configuration, the FX V135 Shoulder Prosthesis 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 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.

The humeral stem of the FX V135 Cementless Shoulder is intended for cementless use only, with optional cortical bone screws for the longer stems. The glenoid components of the FX V135 Shoulder System are intended for cemented use only. The dlenoid baseplate component is intended for cementless use with the addition of screws for fixation.

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

escription Use (Part 21 CFR 801 Subpart D)

er-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.

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Applicant/Sponsor:	FX Shoulder USA, Inc.15920 Addison Road Suite 200Addison, Texas 75001Establishment Registration No: 3014128390
Manufacturer:	FX Solutions1663 Rue de MajornasViriat, France 01440Establishment Registration No: 3009532798
Contact Person:	Cory TrierRegulatory/Compliance Associate
Date:	January 31, 2024
Proprietary Name:	Full Wedge Lateralized and AugmentedBaseplates
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 888.3680: shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis ">– Class II

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Device Description

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 suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The humeral stem of the Humelock Reversed Cemented Shoulder Prosthesis is intended for cemented use only. The humeral stem of the Humelock Reversed

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Cementless Shoulder Prosthesis is lockable with two cortical bone screws and is intended for cementless or cemented stems.

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

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.

When used in the FX V135 Shoulder Prosthesis:

In an anatomic shoulder configuration, the FX V135 Shoulder Prosthesis 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).

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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 components, Full Wedge Lateralized and Augmented Baseplates, are identical to the primary predicate, half wedge lateralized augmented baseplates, on indications, material, manufacturing, packaging, single use, sterilization, shelf life, biocompatibility, compatible components. The subject device is a design modification of the primary predicate that do not raise different questions of safety and effectiveness and is substantially equivalent to the primary predicate.

Non-Clinical Testing

Bench testing for glenoid loosening (ASTM F2028-17) was performed and found to be substantially equivalent to the primary predicate. Range of motion analysis has been completed based upon the same parameters and assumptions as the ROM analysis previously submitted for the primary predicate and demonstrates substantial equivalence as well as exceeding ASTM F-1378-18.

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence of the Full Wedge Lateralized and Augmented Baseplates to the predicate device.

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 Full Wedge Lateralized and Augmented Baseplates are 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.”