(29 days)
No
The summary describes a mechanical shoulder prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for treating severely painful and/or disabled joints resulting from osteoarthritis or traumatic arthritis, which directly addresses a medical condition to alleviate pain and disability.
No
The provided text describes the Arthrex Eclipse Shoulder Prosthesis as an implant for treating severely painful and/or disabled joints resulting from arthritis. It details the materials and fixation methods of the components. There is no mention of the device being used to diagnose conditions; instead, it is a treatment device.
No
The device description explicitly details physical components made of Cobalt Chromium and Titanium alloy, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Arthrex Eclipse Shoulder Prosthesis is a physical implant designed to replace a damaged shoulder joint. It is surgically implanted into the body.
- Intended Use: The intended use is to treat painful and disabled shoulder joints caused by arthritis. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
Product codes
QHQ, PKC
Device Description
The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr) and will be offered with a 16mm offset. The proposed size 37 trunnion is manufactured from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray (TPS) coating. The trunnion will be offered in a slotted design. The Size 37 Head and Trunnion will be used with the existing hollow screws cleared under the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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)
Static and dynamic compression testing presented in the predicate 510(k) clearance is leveraged to demonstrate the fatigue resilience of the proposed Arthrex Eclipse Shoulder Prosthesis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
July 8, 2020
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
Arthrex, Inc. David L. Rogers Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K201542
Trade/Device Name: Arthrex Eclipse Shoulder Prosthesis System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHQ, PKC Dated: June 5, 2020 Received: June 9, 2020
Dear David Rogers:
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
1
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 mediation-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.
For Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K201542
Device Name Arthrex Eclipse Shoulder Prosthesis System
Indications for Use (Describe)
The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.
The humeral component is fixated with a hollow screw and the glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement.
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
| Date Prepared | July 8, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Manager, Regulatory Affairs | |
| 1-239-643-5553 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Eclipse Shoulder Prosthesis System |
| Common Name | Shoulder Prosthesis |
| Product Code | PKC, QHQ |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | Class II |
| Predicate Device | K183194: Arthrex Eclipse Shoulder Prosthesis |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain FDA clearance for a |
| size 37 Humeral Head and Trunnion as a line extension to the Arthrex Eclipse Shoulder | |
| Prosthesis System cleared under K183194. | |
| Device Description | The proposed size 37 humeral head is manufactured from Cobalt Chromium (CoCr) and |
| will be offered with a 16mm offset. The proposed size 37 trunnion is manufactured | |
| from Titanium alloy (Ti6Al4V) with its underside coated with a Titanium Plasma Spray | |
| (TPS) coating. The trunnion will be offered in a slotted design. The Size 37 Head and | |
| Trunnion will be used with the existing hollow screws cleared under the predicate. | |
| Indications for Use | The Arthrex Eclipse Shoulder Prosthesis is indicated for severely painful and/or |
| disabled joint resulting from osteoarthritis or traumatic arthritis. |
The humeral component is fixated with a hollow screw and the glenoid components are
intended for cemented fixation in the joint and must only be used with appropriate
bone cement. |
| Performance Data | Static and dynamic compression testing presented in the predicate 510(k) clearance is
leveraged to demonstrate the fatigue resilience of the proposed Arthrex Eclipse
Shoulder Prosthesis. |
| Conclusion | The Arthrex Eclipse Size 37 has the same intended use and the same fundamental
scientific technology as the Arthrex Eclipse Shoulder Prosthesis System. Based on the
non-clinical data presented in this 510(k), Arthrex concludes that the proposed device is
substantially equivalent to the currently marketed predicate device. |