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 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 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.

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 is lockable with two cortical bone screws and is intended for cementless use only. An optional anti-rotation spoiler can be used with either the cemented stems.

The clenoid 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 ioint 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 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 Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge and may be used with an asymmetric bone defect when there is no possibility to correct this defect without graft or excessive reaming.

AI/ML Overview

This FDA 510(k) summary describes a device, "Lateralized and Augmented Baseplates," that is a modification of existing shoulder prosthesis components. The review focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the new components.

Therefore, the information provided does not fully answer all sections of your request regarding detailed acceptance criteria and a study proving those criteria are met for the new device. However, I can extract the relevant information about the non-clinical testing performed and the general approach to demonstrating equivalence.

Here's a breakdown of the available information based on your request:

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

The document does not provide a formal table of acceptance criteria with specific thresholds for the new Lateralized and Augmented Baseplates. Instead, it refers to prior bench testing conducted for the predicate devices and states that new non-clinical testing for the subject device met acceptance criteria based on those established standards.

Acceptance Criteria (for predicate components, implied for subject device)	Reported Device Performance (for subject device)
Range of Motion (ROM): Based on parameters and assumptions of primary predicates, exceeding ASTM F-1378-18.	ROM analysis demonstrated substantial equivalence to primary predicates and exceeded ASTM F-1378-18.
Glenoid Loosening: Met acceptance criteria per ASTM F2028.	All samples ran to 100,000 cycles with no loosening of glenosphere or baseplate (meeting ASTM F2028 acceptance criteria).

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

The document does not explicitly state the sample sizes for the Range of Motion or Glenoid Loosening tests for the new Lateralized and Augmented Baseplates. It refers to "all samples" for the glenoid loosening test without specifying the number.
The data provenance is not explicitly mentioned as country of origin, but the manufacturer is FX Solutions in Viriat, France. The studies are non-clinical (bench testing).

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

Not applicable. This device assessment relies on established engineering standards (ASTM F-1378-18, ASTM F2028) for non-clinical bench testing, not expert-derived ground truth.

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

Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or subjective assessment. This involved objective measurements against engineering standards.

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 a physical medical device (implant), not an AI/software device that would involve human readers or image interpretation.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for non-clinical testing of the Lateralized and Augmented Baseplates was adherence to established engineering standards (ASTM F-1378-18 for Range of Motion and ASTM F2028 for Glenoid Loosening).

8. The sample size for the training set

Not applicable. This device does not involve a training set in the context of AI or machine learning. Its design and performance are based on engineering principles and testing.

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

Not applicable.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria referred to in this 510(k) is a set of non-clinical bench tests. These tests were performed to demonstrate that the Lateralized and Augmented Baseplates, which are design modifications of previously cleared components, perform similarly to their predicates and meet relevant ASTM standards for mechanical performance.

Range of Motion (ROM) Analysis: This analysis was conducted based on the same parameters and assumptions as previously submitted ROM analyses for the primary predicate devices. It concluded that the subject device demonstrated substantial equivalence in ROM and "exceeding ASTM F-1378-18."
Glenoid Loosening Test: Performed according to ASTM F2028. The report states that "all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate," indicating the device met the acceptance criteria for this standard.

The FDA concluded that "Clinical testing was not necessary to determine substantial equivalence of the Lateralized and Augmented Baseplates to the predicate devices," based on the non-clinical testing and assessment of other factors like materials, manufacturing, and indications for use. This means the non-clinical tests were deemed sufficient to support the substantial equivalence claim.

Summary

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August 25, 2021

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

Re: K210790

Trade/Device Name: 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: August 4, 2021 Received: August 5, 2021

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

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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 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)

K210790

Device Name

Lateralized and Augmented Baseplates

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 clenoid 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 ioint resulting from osteoarthritis or rheumatoid arthritis: -

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary
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, Compliance574.551.1368
Date:	August 17, 2021
Proprietary Name:	Lateralized and Augmented Baseplates
Common Name:	Reverse Shoulder Prosthesis
Product Code(s):	PHX, HSD
Classification Name:	21 CFR 888.3660: shoulder joint metal/polymer semi-constrained cemented prosthesis – Class II21 CFR 888.3690 shoulder joint humeral (hemi-shoulder)metallic uncemented prosthesis – Class II
Substantially EquivalentDevices:	Primary Predicates:Humelock II Reversible Shoulder System (K150488)Baseplate with Screw (K192799)Reference Device:Aequalis PerFORM Reversed, PerFORM+ ReversedGlenoid (K16742, K183696)

Device Description

The Lateralized and Augmented Baseplates are new components for the Humelock II Reversible Shoulder System. They are also components added to the Humelock

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Reversed (K162455) and Humeris Shoulder (K163669), when used for a reverse construct. The Lateralized Baseplate can be used to increase the offset and as needed the Lateralized baseplate with augmentation has an added wedge 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 Lateralized and Augmented Baseplates are the same as those previously cleared compatible components for use as a component in the primary predicate devices. Humelock II Reversible K150488 and Baseplate with Screw K192799, and in the K162455 Humelock Reversed Shoulder System and K163669 Humeris Shoulder, when used for a reverse shoulder construct.

Intended Use / Indications

The patient's ioint 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 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 use only. An optional anti-rotation 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.

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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).

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, Lateralized and Augmented Baseplates, are identical to the primary predicates on indications, material, manufacturing, packaging, single use, sterilization, shelf life, biocompatibility, compatible components. The subject device is a design modification of the primary predicates. The lateralization and augmentation of the subject devices are similar to the reference device. The offset of lateralization is the same as the reference device and the augmentation of the subject device is within the degree of version correction with augmentation of the reference device. The central screw for that variant of the Baseplate options and the peripheral screws of the subject device are within the range of screws available in the reference device system. Any differences between the subject device and the primary predicate device and reference device do not raise new questions of safety and effectiveness; the FX Shoulder Lateralized and Augmented Baseplates are substantially equivalent to the primary predicate and reference device.

Non-Clinical Testing

Previous bench testing has been submitted in the cleared 510(k) submissions for K150488 and K192799. Range of Motion analysis has been completed based upon the same parameters and assumptions as the ROM analysis previously submitted for the primary predicates and demonstrates substantial equivalence as well as exceeding

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ASTM F-1378-18. Glenoid loosening per ASTM F2028 met acceptance criteria and all samples ran to 100,000 cycles with no loosening of glenosphere or baseplate.

Clinical Testing

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

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 predicates submitted here, the Lateralized and Augmented Baseplates are expected to be as safe, as effective, and perform as well as the legally marketed device predicates.

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.”