(387 days)
No
The summary describes a shoulder replacement system and a new coated humeral head component. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, a TiN Coated Humeral Head used in shoulder replacement systems, is indicated for treating conditions like severe pain and/or disability resulting from arthritis and fractures, all of which aim to restore function and alleviate symptoms, thereby providing therapy to the patient.
No
Explanation: The document describes a TiN Coated Humeral Head, which is a component of shoulder replacement systems. Its intended use is for surgical implantation to treat various shoulder conditions (e.g., fractures, arthritis). It is a prosthetic device used for treatment, not for diagnosing a condition.
No
The device description clearly states it is a physical component (TiN Coated Humeral Head) for a shoulder replacement system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the shoulder joint to treat various conditions like fractures, arthritis, and revision surgeries. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a component of a shoulder replacement system, specifically a humeral head with a coating. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the TiN Coated Humeral Head, as described, is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used in the Humelock II Cemented Shoulder System:
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
- Proximal humeral fractures
- 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 humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
TiN coated Heads are not intended for hemi- shoulder arthroplasty.
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).
TiN coated Heads are not intended for hemi- shoulder arthroplasty.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
KWT, PHX
Device Description
The TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 risk management process" (September 2016). Nonclinical biocompatibility testing is the same as the reference device and includes Acute System Toxicity Study; Cytotoxicity; 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; 90 Day 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.
Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
July 16, 2020
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square. 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: K191698
Trade/Device Name: TiN Coated Humeral Head Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, PHX Dated: July 7, 2020 Received: July 8, 2020
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 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
1
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,
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
Enclosure
2
Indications for Use
510(k) Number -K191698
Device Name TiN Coated Humeral Head
Indications for Use (Describe)
When used in the Humelock II Cemented Shoulder System:
The Humelock II Cemented Shoulder System is indicated for use in total and hemi-shoulder replacement to treat:
- Proximal humeral fractures
-
- 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 humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
TiN coated Heads are not intended for hemi- shoulder arthroplasty.
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).
TiN coated Heads are not intended for hemi- shoulder arthroplasty.
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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
| 510(k) Summary | |
|---|---|
| Applicant/Sponsor: | FX Shoulder USA, Inc. |
| 13465 Midway Road, Suite 101 | |
| Dallas, Texas 75244 | |
| Establishment Registration No: 3014128390 | |
| Manufacturer: | FX Solutions |
| 1663 Rue de Majornas | |
| Viriat, France 01440 | |
| Establishment Registration No: 3009532798 | |
| Contact Person: | Kathy Trier, Ph.D. |
| VP Regulatory, Clinical, Quality, Compliance | |
| ktrier@fxshoulder.com | |
| 800.280.0775 | |
| Date: | July 15, 2020 |
| Proprietary Name: | TiN Coated Humeral Heads |
| Common Name: | Anatomic Shoulder Prosthesis |
| Product Code(s): | KWT, PHX |
| Classification Name: | 21 CFR 888.3650: shoulder joint metal/polymer |
| non-constrained cemented prosthesis - Class II | |
| Substantially Equivalent | |
| Devices: | Primary Predicate: |
| Humelock II Cemented Shoulder System (K123814) | |
| Predicate: | |
| Humeris™ Shoulder System (K163669) | |
| Reference Device: | |
| LINK® Endo-Model® Knee System with PorEx®; | |
| LINK® Sled Knee System with PorEx® (K152431) |
Device Description
The TiN Coated Humeral Head is a new component for Humelock II total shoulder replacement systems. The TiN Coated Humeral Head has a titanium nitride (TiN) coating, which is applied to the predicate humeral heads made of cobalt chromium molybdenum (CoCr). Compatible components for use with the TiN coated humeral heads
5
to complete the total shoulder replacement construct are the same as those previously cleared compatible components for use with the CoCr humeral heads in the respective predicate devices, including the primary predicate (K123814) and K163669 for the Humeris Shoulder System.
Intended Use / Indications
When used in the Humelock II Cemented Shoulder System: The Humelock II Cemented Shoulder System is indicated for use in total and hemishoulder replacement to treat:
-
- Proximal humeral fractures
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis 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 humeral stem and glenoid components of the Humelock II Cemented Shoulder System are intended for cemented use only.
TiN coated Heads are not intended for hemi-shoulder arthroplasty
When used with 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).
TiN coated Heads are not intended for hemi-shoulder arthroplasty.
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.
6
Summary of Technologies / Substantial Equivalence
The TiN Coated Humeral Head 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 humeral head, 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 risk management process" (September 2016). Nonclinical biocompatibility testing is the same as the reference device and includes Acute System Toxicity Study; Cytotoxicity; 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; 90 Day 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.
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence of the TiN Coated Humeral Head 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 TiN Coated Humeral Head.