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 is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with 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 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 FX V135™ Shoulder Prosthesis is a shoulder replacement system that may be used as a total or hemi shoulder replacement in either an anatomic or a reversed shoulder construct. The new components of the system included in this submission are the FX V135™ Additional Humeral Stems that are added to the system as a line extension of the cementless humeral stems.
The FX V135™ Shoulder Prosthesis is manufactured from Ti-6l-4V ELI alloy conforming to ISO 5832-3 and are available in diameters of 8-16mm in the diaphysis dependent upon the epiphyseal size 32, 36, and 40mm. The longer stems added to the system are available in lengths 120mm, 180mm and 200mm. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating. The distal end of the humeral stem is cylindrical and bead blasted with unthreaded screw holes oriented in the medial / lateral direction for optional fixation using cortical bone screws.
The FX V135™ Shoulder Prosthesis incorporates a female taper for attachment of compatible components.
The FX V135™ Shoulder Prosthesis can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomic shoulder configuration.
For reverse configuration, the FX V135™ Shoulder Prosthesis can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a qlenoid baseplate (with or without a central screw), optional post extensions and standard (compression) and locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups mate with the FX V135™ Additional Humeral Stems to complete the reverse configuration.

AI/ML Overview

The provided text is a 510(k) summary for the FX V135™ Shoulder Prosthesis, which is a medical device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing independent performance against a specific set of acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies is not available in this document because the device's clearance relied on non-clinical testing and comparison to existing devices, not a new clinical study with performance benchmarks.

Here's an breakdown of why the requested information cannot be fully provided based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable: The document does not define specific "acceptance criteria" for clinical performance. Instead, it states that "Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135™ Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device." This refers to non-clinical mechanical testing, not clinical outcomes.

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

Not Applicable (for clinical data): The document explicitly states: "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device." Therefore, there is no clinical "test set" with associated sample size or data provenance in this submission. For the non-clinical fatigue testing, specific sample sizes are not provided in this summary.

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

Not Applicable: No clinical ground truth was established for a test set, as no clinical study was deemed necessary.

4. Adjudication method for the test set:

Not Applicable: No clinical test set and thus no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No: The document states that clinical testing was not necessary. Therefore, an MRMC study was not conducted.

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

Not Applicable: This device is a physical medical implant (shoulder prosthesis), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The type of ground truth used:

Not Applicable (for clinical ground truth): As no clinical study was conducted, there's no clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the non-clinical testing would be the engineering specifications and performance standards met by the predicate device and reproduced by the subject device.

8. The sample size for the training set:

Not Applicable: This is a physical medical device, not an AI model, so there is no "training set."

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

Not Applicable: As above, no training set.

Summary based on the provided text:

The device, FX V135™ Shoulder Prosthesis, obtained 510(k) clearance by demonstrating "substantial equivalence" to existing predicate devices (FX V135™ Shoulder Prosthesis (K213117), Humelock Reversed® Shoulder (K162455), and Encore Humeral Shoulder Stem (K141990)).

The primary evidence provided in this summary to support this claim comes from non-clinical testing:

"Range of motion analysis demonstrated comparability to the predicate device."
"Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed."

The conclusion is that these non-clinical tests indicate the performance is "adequate for its intended use and substantially equivalent to the predicate device." The document explicitly states, "Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device."

Therefore, the device meets its "acceptance criteria" (which are performance benchmarks derived from the predicate device and established through non-clinical testing) by demonstrating comparable range of motion and successful completion of fatigue testing without failures or loosening. This approach leverages the pre-existing FDA clearance of the predicate devices.

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). 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.

June 5, 2023

FX Shoulder USA, Inc Cory Trier Quality Assurance Associate 13465 Midway Road, Suite 101 Dallas. Texas 75244

Re: K223801

Trade/Device Name: FX V135TM Shoulder Prosthesis 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 Dated: May 5, 2023 Received: May 5, 2023

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 (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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Joseph P. Joseph P. Russell -S Date: 2023.06.05 Russell -S 16:29:19 -04'00'

For: Farzana Sharmin, Ph.D. 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) K223801

Device Name FX V135™ Shoulder Prosthesis

Indications for Use (Describe)

In an anatomic shoulder configuration, the FX V135™ 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 FX V135™ Shoulder is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with 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 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.

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:	Cory TrierQuality Assurance Associate260.610.1028
Date:	June 2, 2023
Proprietary Name:	FX V135™ Shoulder Prosthesis
Common Name:	Anatomic and Reverse Shoulder Prosthesis
Product Code(s):	PHX, KWT, HSD
Classification Name:	21 CFR 888.3650: shoulder joint metal/polymernon-constrained cemented prosthesis – Class II21 CFR 888.3660: Shoulder joint metal/polymersemi-constrained cemented prosthesis – Class II21 CFR 888.3690 shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis – Class I
Substantially EquivalentDevices:	Primary Predicate:FX V135™ Shoulder Prosthesis (K213117)Reference Device:Humelock Reversed® Shoulder (K162455)Encore Humeral Shoulder Stem (K141990)

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Device Description

The FX V135™ Shoulder Prosthesis is manufactured from Ti-6l-4V ELI alloy conforming to ISO 5832-3 and are available in diameters of 8-16mm in the diaphysis dependent upon the epiphyseal size 32, 36, and 40mm. The longer stems added to the system are available in lengths 120mm, 180mm and 200mm. The proximal portion of the humeral stem has a plasma sprayed commercially pure Titanium (CP-Ti) and Hydroxyapatite (HA) coating. The distal end of the humeral stem is cylindrical and bead blasted with unthreaded screw holes oriented in the medial / lateral direction for optional fixation using cortical bone screws.

The FX V135™ Shoulder Prosthesis incorporates a female taper for attachment of compatible components.

The FX V135™ Shoulder Prosthesis can be used with previously cleared components including a taper adapter, a centered or offset humeral head and a 2 peg or 3 or 4 peg cemented glenoid for use in an anatomic shoulder configuration.

For reverse configuration, the FX V135™ Shoulder Prosthesis can be used with a humeral cup and optional spacer, a centered or eccentric glenosphere with or without a central screw, a qlenoid baseplate (with or without a central screw), optional post extensions and standard (compression) and locking bone screws around the periphery of the baseplate. The previously cleared Humeral Cups mate with the FX V135™ Additional Humeral Stems to complete the reverse configuration.

Intended Use / Indications

ln an anatomic shoulder configuration, the FX V135™ 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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In a reverse shoulder configuration, the FX V135™ Shoulder System is indicated for primary or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with 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.

Summary of Technologies / Substantial Equivalence

The new FX V135™ Shoulder Prosthesis is substantially equivalent to the primary predicate in that they are identical to the primary predicate on indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components and identical in design except for length. The subject devices are longer than the primary predicate with 120mm, 200mm lengths. The new FX V135™ Shoulder Prosthesis is similar in design to the Reference Device K162455 with distal holes for cortical bone screws and similar in design to the Reference Device K141990 with proximal suture holes and within the size range. The subject device, FX V135™ Shoulder Prosthesis, is added to the cleared FX V135™ Shoulder System as a line extension, does not raise different questions of safety and effectiveness, and is substantially equivalent to the predicates.

Non-Clinical Testing

Range of motion analysis demonstrated comparability to the predicate device. Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results of these tests indicate that the performance of the FX V135™ Shoulder Prosthesis is adequate for its intended use and substantially equivalent to the predicate device.

Clinical Testing

Clinical testing is not necessary to determine substantial equivalence of the FX V135™ Shoulder Prosthesis to the predicate device.

Conclusions

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Based upon the risk assessment and pre-clinical testing to characterize device performance, substantial equivalence to the predicate device is demonstrated. The FX V135™Shoulder Prosthesis is substantially equivalent based upon indications, design, material, packaging, single use, sterilization, shelf life. The FX V135™ Shoulder Prosthesis is expected to be as safe, as effective, and perform as well as the legally marketed predicate device.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”