Humeris® 135 Shoulder System

K222936 · Fx Shoulder USA, Inc. · PHX · Nov 7, 2022 · Orthopedic

Device Facts

• Record ID: K222936
• Device Name: Humeris® 135 Shoulder System
• Applicant: Fx Shoulder USA, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 Story

Humeris 135 Shoulder System; modular shoulder prosthesis for anatomic or reverse arthroplasty. System includes humeral stems (cemented/cementless), glenoid components, and new humeral cups/spacers providing 135-degree articulation angle. Implanted by orthopedic surgeons in clinical/hospital settings. Device replaces damaged joint surfaces to relieve pain and restore function. Cementless stems utilize Ti-6Al-4V alloy with plasma-sprayed CP Titanium and hydroxyapatite coating; cemented stems utilize Ti-6Al-4V alloy with polished distal surface. System integrates with previously cleared glenospheres and humeral cups. Benefits include improved range of motion and joint stability for patients with severe arthritis or rotator cuff deficiency.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including range of motion analysis and construct fatigue testing.

Technological Characteristics

Materials: Ti-6Al-4V alloy (ISO 5832-3/ISO 5832-2), CP Titanium, hydroxyapatite. Components: Humeral stems, glenoid baseplates, humeral cups, spacers. Configuration: Anatomic or reverse. Fixation: Cemented or cementless. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring total or hemi-shoulder replacement due to osteoarthritis, rheumatoid arthritis, or complex clinical scenarios (e.g., revision of prior implants) in anatomic configuration. Indicated for primary or revision total shoulder arthroplasty in patients with massive, non-repairable rotator cuff tears in reverse configuration. Requires anatomically suitable joint and functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Humeris® Shoulder System (K163669)

Reference Devices

• Humelock II® Reversible Shoulder System (K150488)
• Humelock Reversed® Shoulder System (K162455)

Submission Summary (Full Text)

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November 23, 2022

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency in blue text.

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

Re: K222936

Trade/Device Name: Anatomic & Reverse 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

Dear Cory 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 November 7, 2022. Specifically, FDA is updating this SE Letter as an administrative correction. The original SE letter was not signed.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Victoria Lilling, M.D., OHT6: Office of Orthopedic Devices, [phone], [e-mail].

Sincerely,

Victoria A. Lilling -S Lilling -S Lilling -S
Victoria A. Lilling -S Lilling -S Lilling -S
Date: 2022.11.23 17:57:03 -0500

Victoria Lilling, M.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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

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

November 7, 2022

Re: K222936

Trade/Device Name: Humeris® 135 Shoulder System 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: September 23, 2022 Received: September 26, 2022

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 Mav 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 [phone] or 301-796-7100).

Sincerely.

Victoria Lilling, M.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

Enclosure

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## Indications for Use

510(k) Number (if known) K222936

Device Name Humeris® 135 Shoulder System

#### Indications for Use (Describe)

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 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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(k) Summary

| Applicant/Sponsor: | FX Shoulder USA, Inc.<br>13465 Midway Road, Suite 101<br>Dallas, Texas 75244<br>Establishment Registration No: 3014128390 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | FX Solutions<br>1663 Rue de Majornas<br>Viriat, France 01440<br>Establishment Registration No: 3009532798 |
| Contact Person: | Cory Trier<br>Quality Assurance Associate |
| Date: | September 23, 2022 |
| Proprietary Name: | Humeris® 135 Shoulder System |
| Common Name: | Reverse Shoulder Prosthesis |
| Product Code(s): | PHX, KWT, HSD |
| Classification Name: | 21 CFR 888.3660: shoulder joint metal/polymer<br>semi-constrained cemented prosthesis – Class II<br>21 CFR 888.3650: Shoulder joint metal/polymer<br>semi-constrained cemented prosthesis – Class II<br>21 CFR 888.3690 shoulder joint glenoid (hemi-<br>shoulder) metallic uncemented prosthesis – Class I |
| Substantially Equivalent<br>Devices: | Primary Predicate:<br>Humeris® Shoulder System (K163669) |

# Device Description

The Humeris® 135 Shoulder System adds new components to the previously cleared Humeris Shoulder System (K163669). The additional new components are humeral

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cups eccentric symmetric and a Humeris humeral spacer, which provide a 135 degree angle for articulation with the previously cleared glenospheres and humeral cups (K150488 Humelock II® Reversible Shoulder System and K162455 Humelock Reversed® Shoulder System) when used in a reverse shoulder construct.

The Humeris Shoulder System can be used in either an anatomic or a reverse configuration and includes both cementless and cemented variants of the humeral stems.

The Humeris Cementless Humeral Stem is manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 with a plasma sprayed commercially pure Titanium (CP Ti) and hydroxyapatite (HA) coating at the distal end.

The Humeris Cemented Humeral Stem is also manufactured from Ti-6Al-4V allov conforming to ISO 5832-2 with a trapezoidal a polished surface at the distal end.

## Intended Use / Indications for Use

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 o rheumatoid arthritis;
- . Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a previously implanted primary component, a humeral plate or a humeral nail).

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

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

The humeral stem of the Humeris Cementless Shoulder is intended for cementless use only. The humeral stem of the Humeris Cemented Shoulder is intended for cemented use only.

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

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## Summary of Technologies / Substantial Equivalence

The new Humeris 135 Humeral Cup Eccentric Symmetric and Humeris humeral spacer, are substantially equivalent to the primary predicate in that it is identical to the primary predicate on indications, material, packaging, single use, sterilization, shelf life, pyrogen testing, biocompatibility, compatible components. The subject device, Humeris 135 Humeral Cup and humeral spacer, are added to the cleared Humeris Shoulder System and is a design modification of the currently cleared humeral cup, does not raise different questions of safety and effectiveness and is substantially equivalent to the primary predicate.

## 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 Humeris135 Shoulder System 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 Humeris 135 Shoulder System to the predicate device.

#### Summary

Based upon the risk assessment and pre-clinical testing to characterize device performance, substantial equivalence to the predicate device is demonstrated. The Humeris 135 Shoulder System is substantially equivalent based upon indications. design, material, packaging, single use, sterilization, shelf life. The Humeris 135 Shoulder System is expected to be as safe, as effective, and perform as well as the legally marketed predicate device.