(307 days)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy. The patient's joint must be anatomically 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 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 Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The Arthrex Univers Revers Apex Humeral Stems are Titanium humeral stems with a Calcium Phosphate coating designed to articulate with the Arthrex Univers Revers Shoulder Prosthesis System. The stem will be offered sterile in 10 sizes (Size 6-15). The primary differences between the Arthrex Univers Revers Apex Humeral Stem and the predicate device are that the proposed device is shorter in superior to inferior length and contains two suture holes.
The provided document describes Arthrex Univers Revers Apex Humeral Stems, a medical device, and its 510(k) summary. This document focuses on the performance data provided to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, as might be found for AI/ML devices. As such, the responses below are tailored to the type of information available for this specific product.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Dynamic Fatigue Testing (Compression) | All constructs survived 10 million cycles |
| Dynamic Fatigue Testing (Torsion) | All constructs survived 10 million cycles |
| Bacterial Endotoxin Test (EP 2.6.14/USP <85>) | Meets pyrogen limit specifications |
| Stem Fixation (Engineering Analysis) | Was conducted and presumably demonstrated acceptable fixation (exact criteria not specified in this summary) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify general "test sets" or "data provenance" in the way one would for diagnostic algorithms. Instead, it describes engineering and biological tests conducted on the device components.
- Sample Size: The document does not explicitly state the number of samples (e.g., number of stems) tested for dynamic fatigue or bacterial endotoxin. For dynamic fatigue, it refers to "all constructs," implying that multiple samples were tested, but the exact number isn't given.
- Data Provenance: Not applicable in the context of device performance testing of physical components (e.g., not patient data). The testing was conducted by Arthrex Inc. as part of their premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for mechanical and biological performance is based on established engineering standards and test methods, not expert consensus on diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This device underwent performance testing against engineering standards, not expert adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a mechanical orthopedic implant, not an AI/ML diagnostic tool. Therefore, an MRMC comparative effectiveness study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
No. This is a physical medical device (humeral stem), not a software algorithm.
7. Type of Ground Truth Used
- For dynamic fatigue testing: The ground truth is the established mechanical failure criteria (e.g., fracture, loosening) after a specified number of cycles. The criteria are likely derived from industry standards for orthopedic implants.
- For bacterial endotoxin testing: The ground truth is the established pyrogen limit as defined by pharmacopeia standards (EP 2.6.14/USP <85>).
- For stem fixation: The ground truth is likely based on biomechanical principles and potentially industry standards for implant stability.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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December 14, 2017
Arthrex Inc. David Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K170414
Trade/Device Name: Arthrex Univers Revers Apex Humeral Stems Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX Dated: October 30, 2017 Received: December 5, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K170414
Device Name
Arthrex Univers Revers Apex Humeral Stems
Indications for Use (Describe)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy. The patient's joint must be anatomically 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 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 Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
- | 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 | December 12, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Project Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex Univers Revers Apex Humeral Stems |
| Common Name | Shoulder Prosthesis |
| Product Code | PHX |
| Classification Name | 21 CFR 888.3660 |
| Regulatory Class | II |
| Predicate Device | K161782: Arthrex Univers Revers Shoulder Prosthesis System |
| Reference Predicate | K122698: Tornier Ascend Flex Prosthesis |
| Purpose ofSubmission | This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Univers Revers Apex Humeral Stems as a line extension to theArthrex Univers Revers Humeral Stems cleared under K161782 for use in theArthrex Univers Revers Shoulder Prosthesis System. |
| Device Description | The Arthrex Univers Revers Apex Humeral Stems are Titanium humeral stemswith a Calcium Phosphate coating designed to articulate with the Arthrex UniversRevers Shoulder Prosthesis System. The stem will be offered sterile in 10 sizes(Size 6-15). The primary differences between the Arthrex Univers Revers ApexHumeral Stem and the predicate device are that the proposed device is shorter insuperior to inferior length and contains two suture holes. |
| Indications for Use | The Univers Revers Shoulder Prosthesis System is indicated for use in a grosslyrotator cuff deficient glenohumeral joint with severe arthropathy. The patient'sjoint must be anatomically and structurally suited to receive the selectedimplant(s), and a functional deltoid muscle is necessary to use the device.The Univers Revers Shoulder Prosthesis System is indicated for primary totalshoulder replacement for the relief of pain and significant disability due torotator cuff deficiency. |
| Performance Data | (Humeral) Stems are intended for cemented or cementless applications for usewith Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and isintended for cementless use with the addition of screws for fixation.Dynamic fatigue testing was performed to evaluate the fatigue resilience of theproposed stems. All constructs survived 10 million cycles for both compressionand torsion loading conditions.An engineering analysis was conducted in evaluating stem fixation.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | The Arthrex Univers Revers Apex Humeral Stem is substantially equivalent to thepredicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate device |
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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.
§ 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.”