(42 days)
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.
The Humeris® 135 Shoulder System adds new components to the previously cleared Humeris Shoulder System (K163669). The additional new components are humeral 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.
This document, K222936, is an FDA 510(k) Premarket Notification for the Humeris® 135 Shoulder System. It asserts substantial equivalence to a previously cleared predicate device rather than presenting a de novo study with novel performance criteria. Therefore, the traditional concept of "acceptance criteria" for a new device's performance, as would be found in a clinical trial or a study designed to prove a device meets specific accuracy or efficacy thresholds, is not directly applicable to this submission.
Instead, the acceptance criteria here are focused on demonstrating substantial equivalence to a predicate device. This means the device performs at least as safely and effectively as the predicate, without raising new questions of safety or effectiveness. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing presented to support this claim of substantial equivalence.
Based on the provided text, here's a breakdown of the information requested, framed within the context of a 510(k) submission for substantial equivalence:
Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)
The acceptance criteria for a 510(k) device like the Humeris® 135 Shoulder System are primarily met by demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, fundamental technological characteristics, and similar performance to the predicate, or that any differences do not raise new questions of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (for Substantial Equivalence) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use | The Humeris® 135 Shoulder System has the identical intended use compared to the primary predicate: Anatomic (total and hemi-shoulder replacement for osteoarthritis/rheumatoid arthritis, revision) and Reverse Shoulder (primary or revision total shoulder arthroplasty for massive, non-repairable rotator cuff tears). Any modifications (new humeral cups, spacer) align with these uses. |
| Material | Manufactured from Ti-6Al-4V alloy conforming to ISO 5832-3 (cementless) or ISO 5832-2 (cemented), with plasma sprayed CP Ti and HA coating at the distal end for cementless variant. This is noted as being comparable to the predicate. |
| Design | The Humeris® 135 Shoulder System adds new components (humeral cups eccentric symmetric and a humeral spacer) that provide a 135-degree angle for articulation. These are described as design modifications of the currently cleared humeral cup and are stated not to raise different questions of safety and effectiveness. |
| Packaging, Single Use, Sterilization, Shelf Life, Pyrogen Testing, Biocompatibility | Stated to be identical to the primary predicate device. |
| Compatible Components | Stated to be identical to the primary predicate device, articulating with previously cleared glenospheres and humeral cups. |
| Mechanical Performance (Range of Motion) | Range of motion analysis demonstrated comparability to the predicate device. |
| Mechanical Performance (Construct Fatigue) | Construct fatigue testing was completed with test constructs completing all cycles with no failures and taper connections remaining firmly fixed. The results indicate adequate performance for intended use. |
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the "Range of motion analysis" or "Construct fatigue testing." These types of tests typically involve a defined number of test articles (e.g., specific numbers of implants subjected to fatigue cycling) rather than patient samples.
- Data Provenance: The testing described (Range of motion analysis, Construct fatigue testing) is non-clinical/bench testing. It is conducted in a controlled laboratory environment, not on human subjects. Therefore, provenance like country of origin for patient data or retrospective/prospective status is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This is a 510(k) submission primarily relying on bench testing and comparison to a predicate device. The concept of "ground truth" established by experts for a test set (e.g., for diagnostic accuracy) is not applicable here.
- The determination of substantial equivalence is made by the FDA based on the submission and relevant regulations. Design engineers, materials scientists, and biomechanical engineers would have conducted and interpreted the non-clinical tests.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or outcomes, where human expert consensus is needed to establish ground truth or evaluate performance. This submission relies on non-clinical engineering tests.
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 medical device (shoulder prosthesis) with no AI component or interpretative function. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical implant, not an algorithm or diagnostic imaging device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the non-clinical testing, the "ground truth" is defined by established engineering and material science standards, specifications, and test methodologies (e.g., ISO standards, ASTM standards). The "truth" is whether the device meets predefined mechanical performance thresholds (e.g., completing a certain number of fatigue cycles without failure, demonstrating comparable range of motion as determined by engineering analysis).
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as this is not an AI/ML device requiring a training set.
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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, (240) 402-4017, Victoria.Lilling@FDA.HHS.gov.
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 (1-800-638-2041 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) | |
|---|---|
| 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: | Cory TrierQuality 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/polymersemi-constrained cemented prosthesis – Class II21 CFR 888.3650: Shoulder joint metal/polymersemi-constrained cemented prosthesis – Class II21 CFR 888.3690 shoulder joint glenoid (hemi-shoulder) metallic uncemented prosthesis – Class I |
| Substantially EquivalentDevices: | Primary Predicate: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.
§ 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.”