(117 days)
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes
Explanation: The device is a reverse shoulder prosthesis indicated for patients with severe shoulder arthropathy and a deficient rotator cuff, which is a condition requiring medical intervention to alleviate symptoms and improve function.
No
The device is a prosthesis, specifically a reverse shoulder prosthesis, designed for surgical implantation to replace a diseased or damaged shoulder joint. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is made up of physical components (glenophere, baseplate, and fixation component) manufactured from medical grade titanium alloy and cobalt chromium molybdenum alloy. It also mentions sterilization and mechanical performance testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "REVERSE PROSTHESIS" for surgical implantation in patients with specific shoulder conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder implant (glenosphere, baseplate, screws) made from medical-grade materials. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical testing, sterilization, packaging, and biocompatibility – all relevant to a surgical implant, but not to the analytical performance of an IVD.
In summary, the provided information describes a surgical implant used to treat a medical condition, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Product codes
PHX, KWS, KWT
Device Description
The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.
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
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1), and bacterial endotoxin (LAL) validations and rationales were conducted and provided to demonstrate substantial equivalence. Mechanical performance testing including Axial disassembly of baseplate/glenophere taper connection per ASTM F2009; Shear disassembly of baseplate/glenosphere taper connection per ASTM F1829; Torsion, Driving Torque, Self tapping performance, and Axial Pullout per ASTM F543; baseplate with compensation loosening test per ASTM F2028; Range of Motion, reverse prosthesis per ASTM F1378; fixation on baseplate testing; post fatigue shear disassembly per ASTM F2028/ASTM F2009; Post Fatigue Torsion per ISO 7206-13; and Fretting and Corrosion per ASTM F2009/ ASTM F1875 has been performed on the subject JARVIS Reverse Shoulder Prosthesis. The results have shown them to meet or exceed acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
K171789, K112193, K190588, K193373, K162455, K161742
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains 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.
November 25, 2024
FH Industrie % Christine Scifert Official Correspondent MRC Global 9085 East Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K242253
Trade/Device Name: JARVIS Glenoid 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, KWS, KWS, KWT Dated: October 4, 2024 Received: October 4, 2024
Dear Christine Scifert:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for "Farzana Sharmin -S". The date of the signature is November 25, 2024, at 18:42:03, with a time zone offset of -05'00'.
Farzana Sharmin, PhD 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
JARVIS Glenoid Reverse Shoulder Prosthesis
Indications for Use (Describe)
REVERSE PROSTHESIS
The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
510(k) Summary JARVIS Glenoid Reverse Shoulder Prosthesis 25 November 2024
| Company: | FH INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER Finistere, FRANCE 29000 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Naoual RAHIMI- FH Industrie
Regulatory Affairs Manager
n.rahimi@fhortho.com
+33 (0)2 56 10 20 46 |
| Official Correspondent: | Christine Scifert - MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | JARVIS Glenoid Reverse Shoulder Prosthesis |
| Common Name: | Shoulder Prosthesis, Reverse Configuration
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3660 (Shoulder joint metal/polymer semi-constrained
cemented prosthesis)
21 CFR 888.3650 (Shoulder joint metal/polymer non-constrained
cemented prosthesis) |
| Panel: | Orthopedic |
| Product Code: | PHX, KWS, KWT |
| Primary Predicate: | FH Industrie: Arrow Reverse Shoulder System – K171789 |
| Additional Predicates: | FH Industrie: Arrow Reverse Shoulder System – K112193
Integra LifeSciences Corporation; TITAN Reverse Shoulder System –
K190588
Zimmer Comprehensive Reverse Shoulder System - K193373
FX Shoulder Humelock Reversed Shoulder – K162455
Tornier Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed
Glenoid — K161742 |
5
Device Description:
The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intendedfor primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components - glenophere, baseplate, and fixation component (screw or post) . All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.
Indications for Use:
REVERSE PROSTHESIS
The Jarvis Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
Substantial Equivalence:
The subject device is an expansion of FH Ortho's shoulder portfolio, designed to provide surgeons with options when a reverse shoulder prosthesis is needed. Indications for Use, Materials, and Dimensions for the predicate devices are similar to those of the subject device. Performance testing has shown that the subject meets or exceeds acceptance criteria. Thus, it can be concluded that the subject does not raise different questions about safety and effectiveness.
Performance Testing:
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1), and bacterial endotoxin (LAL) validations and rationales were conducted and provided to demonstrate substantial equivalence. Mechanical performance testing including Axial disassembly of baseplate/glenophere taper connection per ASTM F2009; Shear disassembly of baseplate/glenosphere taper connection per ASTM F1829; Torsion, Driving Torque, Self tapping performance, and Axial Pullout per ASTM F543; baseplate with compensation loosening test per ASTM F2028; Range of Motion, reverse prosthesis per ASTM F1378; fixation on baseplate testing; post fatigue shear disassembly per ASTM F2028/ASTM F2009; Post Fatigue Torsion per ISO 7206-13; and Fretting and Corrosion per ASTM F2009/ ASTM F1875 has been performed on the subject JARVIS Reverse Shoulder Prosthesis. The results have shown them to meet or exceed acceptance criteria.
Conclusion
Based on the test results and the comparison to the predicate device, the subject device is determined to be substantially equivalent to the predicate device.