(59 days)
Not Found
No
The document describes a mechanical shoulder prosthesis and its components. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on mechanical properties and MRI compatibility.
Yes
The device is a "Shoulder Prosthesis System" indicated for "total shoulder replacement for the relief of pain and significant disability," which aligns with the definition of a therapeutic device.
No
This device is a shoulder prosthesis system, an implant used for total shoulder replacement. It is not used to diagnose a medical condition.
No
The device description clearly states it is a humeral stem, which is a physical implant made of titanium and coated. This is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes a shoulder prosthesis system, which is an implantable medical device used to replace a damaged shoulder joint. Its intended use is for surgical implantation to restore function and relieve pain in patients with severe shoulder conditions.
- Lack of Specimen Handling: There is no mention of collecting, preparing, or examining any specimens from the human body. The device is a physical implant.
Therefore, based on the provided information, the Univers Revers Shoulder Prosthesis System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 rotator cuff deficiency.
(Humeral) Stems are intended for 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.
Product codes (comma separated list FDA assigned to the subject device)
PHX, HSD
Device Description
This Traditional 510(k) premarket notification is submitted to obtain clearance for the Arthrex Univers Revers Monoblock Stem Size 4/33 as a line extension to the Arthrex Univers Revers Humeral Stems cleared under K130129 for use in the Arthrex Univers Revers Shoulder Prosthesis System.
The Arthrex Univers Revers Monoblock Stem Size 4/33 is a humeral stem that is manufactured from Titanium (Ti-AL-4V), coated with either Calcium Phosphate (CaP) or Hydroxyapatite (HA), and offered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
glenohumeral joint, 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)
Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposed stem.
Range of motion (ROM) of the subject device is dictated by the ROM of the mating liners and previously cleared components.
Computational electromagnetic method was used to evaluate the surface SAR patterns of the Arthrex Univers Revers MonoBlock Stem under MRI radio frequency (RF) coil emissions at 64-MHz associated with 1.5Tesla and 128-MHz associated with 3Tesla MRI procedures. The surface SAR patterns within the standard ASTM phantom (ASTM F2182-19e2) were obtained. The results indicate that for the device induced heating, the maximum 1g averaged SAR values (corresponding maximum temperature rises) are located near end of the device.
Based on the in-vivo modeling, the maximum temperature rise after 60 minutes exposure is less than 6 degrees Celsius under the condition of the WB SAR at 2W/kg inside tissue and WB SAR at 1W/kg inside the bone.
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.
K130129, K170414, K171841, K181555, K221232
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.
Not Found
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
§ 888.3660 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
April 10, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle and a human figure. The FDA acronym is in a blue square, and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue text to the right of the square.
Arthrex Inc. Tiffany Mentzel Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K230366
Trade/Device Name: Arthrex Univers Revers Monoblock Stem Size 4/33 Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD Dated: February 10, 2023 Received: February 10, 2023
Dear Tiffany Mentzel:
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
1
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 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,
Farzana Sharmin -S
Farzana Sharmin, PhD 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 (if known) K230366
Device Name
Arthrex Univers Revers Monoblock Stem Size 4/33
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 rotator cuff deficiency.
(Humeral) Stems are intended for 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Date Prepared | April 10, 2023 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Name: Tiffany Mentzel |
| Title: Principal Regulatory Affairs Specialist | |
| Phone: (239)-643-5553 ext. 75833 | |
| Email: Tiffany.Mentzel@Arthrex.com | |
| Trade Name | Arthrex Univers Revers Monoblock Stem Size 4/33 |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX, HSD |
| Classification Name | 21 CFR 888.3660: Shoulder joint metal/polymer semi- |
| constrained cemented prosthesis | |
| 21 CFR 888.3690: Shoulder joint humeral (hemi- | |
| shoulder) metallic uncemented prosthesis | |
| Regulatory Class | II |
| Primary Predicate Device | K130129: Univers Revers Shoulder Prosthesis System |
| Additional Predicates | K170414: Arthrex Univers Revers Apex Humeral Stems |
| K171841: Arthrex Shoulder System | |
| K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis | |
| K221232: Univers Revers Humeral Cup Implant | |
| Device Description | This Traditional 510(k) premarket notification is submitted to |
| obtain clearance for the Arthrex Univers Revers Monoblock | |
| Stem Size 4/33 as a line extension to the Arthrex Univers | |
| Revers Humeral Stems cleared under K130129 for use in the | |
| Arthrex Univers Revers Shoulder Prosthesis System. | |
| The Arthrex Univers Revers Monoblock Stem Size 4/33 is a | |
| humeral stem that is manufactured from Titanium (Ti-AL-4V), | |
| coated with either Calcium Phosphate (CaP) or | |
| Hydroxyapatite (HA), and offered sterile. | |
| Indications for Use | The Univers Revers Shoulder Prosthesis System is indicated |
| for use 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 rotator cuff | |
| deficiency. | |
| Performance Data | (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. | |
| Dynamic fatigue testing was performed to evaluate the fatigue | |
| resilience of the proposed stem. | |
| Range of motion (ROM) of the subject device is dictated by | |
| the ROM of the mating liners and previously cleared | |
| components. | |
| Computational electromagnetic method was used to evaluate | |
| the surface SAR patterns of the Arthrex Univers Revers | |
| MonoBlock Stem under MRI radio frequency (RF) coil | |
| emissions at 64-MHz associated with 1.5Tesla and 128-MHz | |
| associated with 3Tesla MRI procedures. The surface SAR | |
| patterns within the standard ASTM phantom (ASTM F2182- | |
| 19e2) were obtained. The results indicate that for the device | |
| induced heating, the maximum 1g averaged SAR values | |
| (corresponding maximum temperature rises) are located near | |
| end of the device. | |
| Based on the in-vivo modeling, the maximum temperature | |
| rise after 60 minutes exposure is less than 6 degrees Celsius | |
| under the condition of the WB SAR at 2W/kg inside tissue | |
| and WB SAR at 1W/kg inside the bone. | |
| Technological Comparison | Compared to the predicate (K130129), the only difference is |
| the size. The proposed line extension has the same | |
| indications for use, is manufactured from the same materials, | |
| undergo the same manufacturing processing, undergo the | |
| same sterilization process, are packaged in the same | |
| packaging configuration, and have the same shelf-life as the | |
| predicate. | |
| Conclusion | The Arthrex Univers Revers Apex Humeral Stem is |
| substantially equivalent to the predicate device in which the | |
| basic design features and intended uses are the same. Any | |
| differences between the proposed device and the predicate | |
| device are considered minor and do not raise questions | |
| concerning safety or effectiveness. | |
| Based on the indications for use, technological | |
| characteristics, and the summary of data submitted, Arthrex | |
| Inc. has determined that the proposed device is substantially | |
| equivalent to the currently marketed predicate device. |
4