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 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 System 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 hemishoulder 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.q. 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 Humelock TiN Coated Glenosphere is a new component for Humelock II, Humelock Reversed, and Humeris reversed total shoulder replacement systems. The Humelock TiN Coated Glenosphere has a titanium nitride (TiN) coating, which is applied to the predicate glenosphere made of cobalt chromium molybdenum (CoCr). Compatible components for use with the Humelock TiN Coated Glenosphere to complete the reversed total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr glenospheres in the primary predicate device, K150488 and are also components in K162455 for the Humelock Reversed Shoulder System and K163669 for the Humeris Shoulder, when used for a reverse shoulder construct.

AI/ML Overview

This document describes the Humelock TiN Coated Glenosphere, a new component for shoulder replacement systems. Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance (Summary)
Biocompatibility	Acute System Toxicity Study	Completed; same as reference device
	Cytotoxicity Study	Completed; same as reference device
	GC/MS Fingerprint Study	Completed; same as reference device
	Irritation Study	Completed; same as reference device
	Sensitization Study	Completed; same as reference device
	Bone Implantation Study	Referenced for subject device
	28 Day Muscle Implantation Study	Referenced for subject device
	90 Day Muscle Implantation Study	Referenced for subject device
Material Characterization	Characterization of TiN coating	Demonstrates substantial equivalence to reference device coating
Mechanical Performance	Wear testing (worst-case loading & environment)	Completed; analysis of surface roughness, UHMWPE, and metal particles done
	Mechanical testing for the complete system	Previously submitted with the cleared predicate device
Safety and Effectiveness	Risk analysis, design controls, verification & validation activities	Demonstrate TiN coating does not increase risk or raise new questions of safety and effectiveness.
Substantial Equivalence (Overall)	Identical to primary predicate in indications, design, dimensions, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components, instrumentation, surgical technique.	Device is identical to primary predicate material (CoCr) with the addition of TiN coating. The coating technology is substantially equivalent to the reference device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific tests. The document mentions "wear testing" and "biocompatibility testing" but doesn't provide the number of devices or samples used for these non-clinical tests.
Data Provenance: All testing mentioned is non-clinical (e.g., in-vitro, material characterization, animal studies). There is no patient data involved in this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable as the evaluation relies solely on non-clinical testing and substantial equivalence to previously cleared devices and a reference device. There are no "ground truth" labels established by human experts on a clinical test set.

4. Adjudication Method for the Test Set

This is not applicable as there is no clinical test set requiring human adjudication.

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 comparative effectiveness study was not done. This submission is for a physical medical device (implant component) and does not involve AI or human readers.

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

No, a standalone algorithm performance study was not done. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established through objective scientific methods and standards for material characterization, mechanical testing, and biocompatibility, as well as the established safety and effectiveness profiles of the predicate and reference devices. For instance, biocompatibility is evaluated against ISO standards, and mechanical wear is measured.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

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July 22, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K191146

Trade/Device Name: Humelock TiN Coated Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, HSD

Dear Kathy Trier:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 15, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Owens, OHT6: Office of Orthopedic Devices, 301-796-5650, Michaelc.Owens@fda.hhs.gov.

Sincerely.

Image /page/0/Picture/9 description: The image shows the name "Michael C. Owens -S" on the left side of the image. On the right side of the image, it says "Digitally signed by Michael C. Owens -S" followed by the date "2020.07.22" and the time "14:24:54 -04'00'".

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

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Image /page/1/Picture/0 description: The image contains 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 the FDA logo, which 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.

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

Re: K191146

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

July 15, 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,

Michael C. Owens -S

Digitally signed by Michael C. Owens -S Date: 2020.07.15 11:13:55 -04'00'

Enclosure

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Indications for Use

510(k) Number (if known) K191146

Device Name Humelock TiN Coated Glenosphere

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 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 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 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 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)

X 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, Clinical, Quality, Compliancektrier@fxshoulder.com800.280.0775
Date:	July 13, 2020
Proprietary Name:	Humelock TiN Coated Glenosphere
Common Name:	Shoulder Prosthesis, Reverse Configuration
Product Code(s):	PHX, KWT, HSD
Classification Name:	21 CFR 888.3660: shoulder joint metal/polymersemi-constrained cemented prosthesis – Class II
Substantially Equivalent Devices:	Primary Predicate:Humelock II Reversible Shoulder System (K150488)Predicates:Humelock Reversed Shoulder System (K162455)Humeris Shoulder System (K163669)Reference Device:LINK® Endo-Model® Knee System with PorEx®; LINK®Sled Knee System with PorEx® (K152431)

Device Description

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with the Humelock TiN Coated Glenosphere to complete the reversed total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr glenospheres in the primary predicate device, K150488 and are also components in K162455 for the Humelock Reversed Shoulder System and K163669 for the Humeris Shoulder, 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 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: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.q. 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 Humelock TiN Coated Glenosphere is substantially equivalent to the primary predicate in that it is identical to the primary predicate on indications, design, dimensions, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components, instrumentation and surgical technique. It is identical to the primary predicate material CoCr. The change, subject of this 510(k), is to add the titanium nitride (TiN) coating to the surface of the glenosphere, which is substantially equivalent to the technology of coating on the reference device based upon the characterization and testing in accordance with the same scientific methods and standards. Differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness.

Non-Clinical Testing

Biocompatibility testing has been completed in accordance with FDA Guidance titled, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk manaqement process" (September 2016).Non-clinical biocompatibility testing is the same as the reference device and includes Acute System Toxicity Study: Cytotoxicity Study: GC/MS Fingerprint Study: Irritation Study: Sensitization Study. Characterization of the TiN coating demonstrates substantial equivalence of the subject device to the coating of the reference device - Bone Implantation Study, 28 Day Muscle Implantation Study: 90Day Muscle Implantation Study are referenced for the subject device. Wear testing under worst case loading and worst case environment with analysis of surface roughness and both UHMWPE and metal particle analysis have been completed.

Mechanical testing for the complete system was previously submitted with the cleared predicate device.

Clinical Testing

Clinical testing was not necessary to determine substantial equivalence of the Humelock TiN Coated Glenosphere to the predicate devices.

Conclusion

The subject device is identical to the primary predicate with the only modification of added TiN coating. The evidence reviewed to demonstrate substantial equivalence includes risk analysis, design controls, biocompatibility, wear properties of the TIN coating, and verification and validation activities to demonstrate that the TiN coating does not increase risk and does not raise new questions of safety and effectiveness of the Humelock TiN Coated Glenosphere.

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.”