(20 days)
The Univers Revers Shoulder Prosthesis System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The subject devices are comprised of size 33 humeral suture-cups, spacers and inserts. The subject devices are made of either titanium or UHMWPE. The subject devices are smaller versions than those cleared in K161782 and K142863. The subject devices are compatible with the Univers Revers Shoulder Prosthesis System and Univers Revers Modular Glenoid System devices.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. Instead, it is a 510(k) premarket notification for a medical device called the "Univers Revers Humeral Cup Implant," which is a shoulder prosthesis.
The document discusses:
- Device Name: Univers Revers Humeral Cup Implant
- Manufacturer: Arthrex Inc.
- Regulatory Classification: Class II
- Product Codes: HSD, PHX
- Purpose of Submission: To obtain clearance for smaller size 33 humeral cup components for use with an already cleared shoulder prosthesis system.
- Technological Characteristics: The new components are made of the same materials (titanium or UHMWPE) as the predicates, have the same intended use/indications, packaging, shelf life, and sterilization. They simply expand the size range of cleared humeral implants.
- Performance Data: "Mechanical testing (i.e., PE liner/cup interface per ASTM F1820) was performed."
- Conclusion: The device is substantially equivalent to predicate devices, and mechanical testing demonstrates equivalent performance.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI/ML, as this document is about a mechanical orthopedic implant, not an AI/ML powered device.
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May 19, 2022
Arthrex Inc. Ivette Galmez Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K221232
Trade/Device Name: Univers Revers Humeral Cup Implant Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Regulatory Class: Class II Product Code: HSD, PHX Dated: April 27, 2022 Received: April 29, 2022
Dear Ivette Galmez:
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.
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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 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.
Lixin Liu, Ph.D. 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) K221232
Device Name
Univers Revers Humeral Cup Implant
Indications for Use (Describe)
The Univers Revers Shoulder Prosthesis System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and 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
| 510(k) Summary | |
|---|---|
| Date Prepared | May 18, 2022 |
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Ivette GalmezRegulatory Affairs Principal Specialist1-239-643-5553, ext. 71263ivette.galmez@arthrex.com |
| Name of Device | Univers Revers Humeral Cup Implant |
| Common Name | Shoulder Prosthesis |
| Product Code | HSD, PHX |
| Classification Name | 21 CFR 888.3690: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulatory Class | II |
| Predicate Device | K161782: Arthrex Univers Revers Shoulder Prosthesis System |
| Reference Device | K142863: Arthrex Univers Revers Shoulder Prosthesis SystemK191960: Arthrex Univers Revers Modular Glenoid SystemK173900: Arthrex Univers Revers Modular Glenoid System |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for size 33 humeral cupcomponents for use with the Univers Revers Shoulder Prosthesis System cleared under K161782. |
| Device Description | The subject devices are comprised of size 33 humeral suture-cups, spacers and inserts. The subjectdevices are made of either titanium or UHMWPE. The subject devices are smaller versions than thosecleared in K161782 and K142863. The subject devices are compatible with the Univers ReversShoulder Prosthesis System and Univers Revers Modular Glenoid System devices. |
| Indications for Use | The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficientglenohumeral joint with severe arthropathy or a previously failed joint replacement with a grossrotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receivethe selected implant(s), and a functional deltoid muscle is necessary to use the device.The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision totalshoulder replacement for the relief of pain and significant disability due to gross rotator cuffdeficiency.(Humeral) Stems are intended for cemented of cementless applications for use with Arthrex HumeralSutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with theaddition of screws for fixation. |
| Summary ofTechnologicalCharacteristics | The subject devices are made of the same materials as the predicates. The subject devices have thesame intended use/indications, packaging, shelf life and sterilization as the predicates. This submissionexpands the size range of the cleared humeral components (suture cup, spacer, and inserts) byintroducing the smallest size 33 humeral implants. |
| Performance Data | Mechanical testing (i.e., PE liner/cup interface per ASTM F1820) was performed. |
| Conclusion | The subject devices are substantially equivalent to the predicate devices in which the basic designfeatures and intended use are the same. The mechanical testing data demonstrates that the subjectdevice performance is equivalent to the predicate device for the desired indications. Any differencesbetween the subject and the predicate device are considered minor and do not raise differentquestions regarding safety or effectiveness.Based on the indications for use, technological characteristics, and the summary of data submitted,Arthrex Inc. has determined that the subject device is substantially equivalent to the currentlymarketed predicate device. |
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.