(316 days)
No
The summary describes a mechanical implant device and its components. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No.
The device is an implantable orthopedic prosthetic component (Heads and Adapters) used to convert an existing reverse total shoulder prosthesis to an anatomic hemi-shoulder replacement, not a therapeutic device in the sense of delivering therapy or treatment.
No
This device is an orthopedic implant designed to convert a reverse total shoulder prosthesis to an anatomic hemi-shoulder replacement. It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the device consists of physical components (CA Heads and Adapters made of cobalt chrome, Titanium, and UHMWPE) which are implanted medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant used to replace or convert a shoulder prosthesis. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components (heads and adapters) made of materials like cobalt chrome, titanium, and UHMWPE, designed for surgical implantation. This aligns with a medical device, not an IVD.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing (static loading, endurance, etc.) of the implant's physical properties, which is typical for a medical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Arthrex Univers Revers CA Heads and Adapters are indicated for
- . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
- . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
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
Product codes
HSD, PHX
Device Description
The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.
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
The submitted in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) demonstrate that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Revers CA Heads and Adapters are adequate for their intended use. Clinical data and conclusions are not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 19, 2016
Arthrex, Incorporated Ms. Courtney Smith Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151527
Trade/Device Name: Arthrex Univers Revers CA Heads and Adapters 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: March 9, 2016 Received: March 11, 2016
Dear Ms. Smith:
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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
1.1 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Arthrex Univers Revers CA Heads and Adapters
Indications for Use (Describe)
The Arthrex Univers Revers CA Heads and Adapters are indicated for
- . salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
- . conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
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
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Date Summary Prepared April 12, 2016 Manufacturer/ Arthrex, Inc. Distributor/ 1370 Creekside Boulevard Sponsor Naples, FL 34108-1945 USA 510(k) Contact Courtney Smith Manager, Regulatory Affairs Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 USA Telephone: 239/643.5553, ext.71720 Fax: 239/598.5508 Email: Courtney.Smith@Arthrex.com Trade Name Arthrex Univers Revers CA Heads and Adapters Common Name Shoulder Prosthesis Product Code, HSD - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, Classification Name, CFR CFR 888.3690 PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660 Predicate Device Primary Predicate K130675: Arthrex Univers II CA Heads Reference Predicates: K130129 / 142863: Arthrex Univers Revers Prosthesis Shoulder System Purpose of Submission This traditional 510(k) premarket notification is submitted to obtain clearance for a line extension to the Arthrex Univers Revers Shoulder Prosthesis System. Device Description The Arthrex Univers Revers CA Heads and Adapters consist of a line of CA Heads and Adapters which are designed to be used with the existing well-fixated Revers stem of the Univers Revers Shoulder Prosthesis System (K130129 and K142863). The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Head were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II The proposed Arthrex Univers Revers CA Heads have a CA Heads (K130675). similar spherical articulating surface as that of the previously cleared heads and are available in 14 nominal sizes. The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes.
510K SUMMARY OF SAFETY AND EFFECTIVENESS 1.1
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| Intended Use | The Arthrex Univers Revers CA Heads and Adapters are indicated for salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted. 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 |
|---|---|
| Substantial | |
| Equivalence Summary | The Arthrex Univers Revers CA Heads and Adapters is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex Univers Revers CA Heads and Adapters and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
| The proposed devices are substantially equivalent to the predicate devices in regards to its intended use, design, size range, and material. The Arthrex Univers Revers CA Heads and Adapters will convert existing reversed shoulder prosthesis to a hemi anatomic configuration. The cobalt chrome CA Heads are available in 14 nominal sizes, and were designed with a larger area of articulation to allow for articulation with the acromion in patients with gross rotator cuff deficiency, similar to the Univers II CA Heads (K130675). The Adapters are manufactured from Titanium and UHMWPE and are available in 3 nominal sizes. The submitted in-vitro testing (static loading, endurance, fretting corrosion, disengagement, torque out) demonstrate that the performance of the proposed devices is substantially equivalent to that of the predicate devices. The mechanical data indicate that the Arthrex Univers Revers CA Heads and Adapters are adequate for their intended use. Clinical data and conclusions are not needed for this device. | |
| Based on the indication for use, technological characteristics, and the comparison to the predicate device, Arthrex, Inc. has determined that the Arthrex Univers Revers CA Heads and Adapters are substantially equivalent to currently marketed predicate devices. |