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.
Device Story
The Arthrex Univers Revers Monoblock Stem Size 4/33 is a humeral stem implant used in total shoulder arthroplasty. It serves as a line extension to the existing Univers Revers Shoulder Prosthesis System. The device is implanted by an orthopedic surgeon during shoulder replacement surgery to address pain and disability caused by rotator cuff deficiency. It functions as a structural component of the prosthetic joint, providing stability and articulation when paired with compatible Arthrex components. The device is manufactured from titanium alloy and features a calcium phosphate or hydroxyapatite coating to facilitate fixation. It is provided sterile for surgical use.
Clinical Evidence
No clinical data provided. Evidence consists of bench testing, including dynamic fatigue testing to evaluate resilience and computational electromagnetic modeling (per ASTM F2182-19e2) to assess MRI safety at 1.5T and 3T. Modeling demonstrated a maximum temperature rise of <6°C after 60 minutes of exposure under specified SAR conditions.
Technological Characteristics
Humeral stem manufactured from Titanium (Ti-Al-4V) with Calcium Phosphate (CaP) or Hydroxyapatite (HA) coating. Designed for cementless application. Evaluated for MRI compatibility per ASTM F2182-19e2. Provided sterile.
Indications for Use
Indicated for patients with grossly rotator cuff deficient glenohumeral joints, severe arthropathy, or failed joint replacements requiring primary, fracture, or revision total shoulder replacement. Requires anatomically/structurally suited joints and functional deltoid muscles.
Regulatory Classification
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).
Special Controls
*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.”
Predicate Devices
Univers Revers Shoulder Prosthesis System (K130129)
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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
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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
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## 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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# 510(k) Summary
| Date Prepared | April 10, 2023 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Name: Tiffany Mentzel<br>Title: Principal Regulatory Affairs Specialist<br>Phone: (239)-643-5553 ext. 75833<br>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-<br>constrained cemented prosthesis<br>21 CFR 888.3690: Shoulder joint humeral (hemi-<br>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<br>K171841: Arthrex Shoulder System<br>K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis<br>K221232: Univers Revers Humeral Cup Implant |
| Device Description | This Traditional 510(k) premarket notification is submitted to<br>obtain clearance for the Arthrex Univers Revers Monoblock<br>Stem Size 4/33 as a line extension to the Arthrex Univers<br>Revers Humeral Stems cleared under K130129 for use in the<br>Arthrex Univers Revers Shoulder Prosthesis System.<br>The Arthrex Univers Revers Monoblock Stem Size 4/33 is a<br>humeral stem that is manufactured from Titanium (Ti-AL-4V),<br>coated with either Calcium Phosphate (CaP) or<br>Hydroxyapatite (HA), and offered sterile. |
| Indications for Use | The Univers Revers Shoulder Prosthesis System is indicated<br>for use in a grossly rotator cuff deficient glenohumeral joint<br>with severe arthropathy or a previously failed joint<br>replacement with a gross rotator cuff deficiency. The patient's<br>joint must be anatomically and structurally suited to receive<br>the selected implant(s), and a functional deltoid muscle is<br>necessary to use the device.<br>The Univers Revers Shoulder Prosthesis System is indicated<br>for primary, fracture, or revision total shoulder replacement for<br>the relief of pain and significant disability due to rotator cuff<br>deficiency. |
| | |
| Performance Data | (Humeral) Stems are intended for cemented or cementless<br>applications for use with Arthrex Humeral SutureCups. The<br>glenoid baseplate is CaP coated and is intended for<br>cementless use with the addition of screws for fixation.<br>Dynamic fatigue testing was performed to evaluate the fatigue<br>resilience of the proposed stem. |
| | Range of motion (ROM) of the subject device is dictated by<br>the ROM of the mating liners and previously cleared<br>components. |
| | Computational electromagnetic method was used to evaluate<br>the surface SAR patterns of the Arthrex Univers Revers<br>MonoBlock Stem under MRI radio frequency (RF) coil<br>emissions at 64-MHz associated with 1.5Tesla and 128-MHz<br>associated with 3Tesla MRI procedures. The surface SAR<br>patterns within the standard ASTM phantom (ASTM F2182-<br>19e2) were obtained. The results indicate that for the device<br>induced heating, the maximum 1g averaged SAR values<br>(corresponding maximum temperature rises) are located near<br>end of the device. |
| | Based on the in-vivo modeling, the maximum temperature<br>rise after 60 minutes exposure is less than 6 degrees Celsius<br>under the condition of the WB SAR at 2W/kg inside tissue<br>and WB SAR at 1W/kg inside the bone. |
| Technological Comparison | Compared to the predicate (K130129), the only difference is<br>the size. The proposed line extension has the same<br>indications for use, is manufactured from the same materials,<br>undergo the same manufacturing processing, undergo the<br>same sterilization process, are packaged in the same<br>packaging configuration, and have the same shelf-life as the<br>predicate. |
| Conclusion | The Arthrex Univers Revers Apex Humeral Stem is<br>substantially equivalent to the predicate device in which the<br>basic design features and intended uses are the same. Any<br>differences between the proposed device and the predicate<br>device are considered minor and do not raise questions<br>concerning safety or effectiveness. |
| | Based on the indications for use, technological<br>characteristics, and the summary of data submitted, Arthrex<br>Inc. has determined that the proposed device is substantially<br>equivalent to the currently marketed predicate device. |
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Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
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Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
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Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
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A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
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The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
