(198 days)
The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The TITAN Reverse Shoulder System is indicated for primary, fractures - including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.
The TITAN Reverse Total Shoulder System is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral poly liners. The poly liners are available in varying thicknesses and constraints to achieve stability and offset of the glenohumeral joint. The variable length reverse bodies and proximally-filling shape are designed to accommodate the natural humeral geometry, providing stable fixation as well as proximal bone loading. The glenoid components are composed of a baseplate secured by a central compression screw and four peripheral screws, two of which can be locked. A glenosphere is attached to the baseplate via taper lock. Glenospheres are available in varying offsets and lateralizations. The stems are intended for
The provided text describes a 510(k) premarket notification for a medical device, the Integra TITAN Reverse Shoulder System, with a specific focus on a coating change. It outlines the regulatory process and provides a summary of nonclinical performance data used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Evaluation of RSS Glenoid Component Loosening or Disassociation | The glenoid component must be as resistant to loosening, disassociation of modular components, and dislocation as the predicate device. | The glenoid component is as resistant to loosening, disassociation of modular components, and dislocation as the predicate. |
| Reverse Shoulder System Fatigue Test | The coating change must have no effect on the implant fatigue strength. | The coating change has no effect on the implant fatigue strength. |
| Evaluation of RSS Implant Titanium Plasma Spray Coating | The coating must meet all acceptance criteria presented in the FDA documents: "Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis" and "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements". | The coating meets all acceptance criteria presented in the FDA documents. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for the test sets in the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation). It mentions that "The TITAN Reverse Shoulder System has undergone the following performance testing," implying that these were conducted on samples of the device components.
The data provenance is from nonclinical performance data (laboratory testing) conducted by the manufacturer, Integra Lifesciences Corp. No information on country of origin for the data is provided beyond being internal testing for the US market. The studies are prospective in nature, as they are specifically conducted to support the 510(k) submission for the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For nonclinical performance tests of a medical device like this, ground truth is typically established by the results of standardized engineering and materials tests (e.g., measuring force, displacement, fatigue cycles) rather than by expert consensus in the way a clinical study would use radiologists or pathologists. The acceptance criteria themselves, referencing FDA guidance documents, serve as a form of "ground truth" for what constitutes acceptable performance for these types of tests.
4. Adjudication Method for the Test Set
This is not applicable as the tests are nonclinical (laboratory-based) and do not involve human interpretation or subjective assessment that would require an adjudication method. The results are quantitative measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical performance data are not required to demonstrate substantial equivalence to the predicate device, as there have been no changes to fit, form, or function of the device." This indicates that the 510(k) submission relies solely on nonclinical (bench) testing to show that the coating change does not alter the fundamental safety or effectiveness compared to the predicate device. Therefore, there's no discussion of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (or any study related to an algorithm or AI) was not done. This device is a mechanical implant (Titanium Reverse Shoulder System) and does not involve AI or algorithms.
7. Type of Ground Truth Used
The ground truth used for the performance tests (Dynamic Evaluation, Fatigue Test, Coating Evaluation) is based on pre-defined acceptance criteria derived from FDA guidance documents and industry standards for mechanical and material properties of orthopedic implants. These criteria specify acceptable limits for mechanical performance (resistance to loosening, fatigue strength) and material characteristics (coating properties).
8. Sample Size for the Training Set
This information is not applicable. Since the device is a mechanical implant and not an AI/ML algorithm, there is no "training set." The engineering tests are performed on physical samples of the device components.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set for a mechanical device. The "ground truth" for evaluating the performance of the device is established by the specified acceptance criteria for the nonclinical tests.
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Integra LifeSciences Corporation Blesson Abraham Sr. Regulatory Affairs Associate 8700 Cameron Road Suite 100 Austin, Texas 78754
June 21, 2018
Re: K173717
Trade/Device Name: Integra TITAN Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: December 4, 2017 Received: December 5, 2017
Dear Mr. Abraham:
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 (QS) regulation (21 CFR Part 820);
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Page 2 - Blesson Abraham
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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
510(k) Number (if known)
K173717
Device Name Integra TITAN Reverse Shoulder System
Indications for Use (Describe)
The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.
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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Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change
Section 7: 510(k) Summary
| Sponsor | Integra Lifesciences Corp.311 Enterprise DrivePlainsboro, NJ 08536 |
|---|---|
| EstablishmentNumber | 1651501 |
| Point of Contact | Kathleen McGuireAssociate, Regulatory Affairs609-936-7916311 Enterprise DrivePlainsboro, NJ 08536 |
| Date | December 4, 2017 |
| Trade Name | Integra TITAN Reverse Shoulder System |
| Common Name | Reverse Total Shoulder |
| ClassificationPanel | Orthopedic |
| Classification | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulation | Class II (under 21 CFR 888.3660) |
| Product Code | PHX |
| Predicate Device | K161189: Integra TITAN Reverse Shoulder System |
| Device Description | The TITAN Reverse Total Shoulder System is a semi-constrainedtotal shoulder construct. The humeral components consist of humeralstems, reverse bodies of varying heights, and humeral poly liners.The poly liners are available in varying thicknesses and constraints toachieve stability and offset of the glenohumeral joint. The variablelength reverse bodies and proximally-filling shape are designed toaccommodate the natural humeral geometry, providing stable fixationas well as proximal bone loading. The glenoid components arecomposed of a baseplate secured by a central compression screw andfour peripheral screws, two of which can be locked. A glenosphere isattached to the baseplate via taper lock. Glenospheres are available invarying offsets and lateralizations. The stems are intended for |
| Intended Use | The TITAN Reverse Shoulder System is indicated for use in agrossly deficient rotator cuff joint with severe arthropathy or aprevious failed joint replacement with a grossly deficient rotator cuffjoint. The patient's joint must be anatomically and structurally suitedto receive the selected implants and a functional deltoid muscle isnecessary to use the device. The TITAN Reverse Shoulder System isindicated for primary, fractures - including proximal humeral, orrevision total shoulder replacement for the relief of pain andsignificant disability due to gross rotator cuff deficiency. The glenoidbase plate is intended for cementless application with the addition ofscrews for fixation. The humeral stem is indicated for cemented oruncemented use and the humeral body component is intended forcementless use. |
| Comparison toPredicate | The proposed device is the same as the predicate in terms of fit, form,and function. The sole modification to the system is that the coatingon the implant baseplate and body has been changed from vacuum-sintered titanium Asymmatrix™ to titanium plasma spray. |
| NonclinicalPerformance Data | The TITAN Reverse Shoulder System has undergone the followingperformance testing to confirm the system's ability to perform underanticipated clinical conditions.1. Dynamic Evaluation of RSS Glenoid Component Looseningor DisassociationThe glenoid component is as resistant to loosening,disassociation of modular components, and dislocation as thepredicate.2. Reverse Shoulder System Fatigue TestThe coating change has no effect on the implant fatiguestrength.3. Evaluation of RSS Implant Titanium Plasma Spray CoatingThe coating meets all acceptance criteria presented in theFDA documents "Class II Special Controls Guidance:Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis" and"Guidance for Industry on the Testing of Metallic PlasmaSprayed Coatings on Orthopedic Implants to SupportReconsideration of Postmarket Surveillance Requirements". |
| ClinicalPerformance Data | Clinical performance data are not required to demonstrate substantialequivalence to the predicate device, as there have been no changes tofit, form, or function of the device. |
| ConclusionsDrawn fromPerformance Data | The performance data demonstrate that the coating change does notraise any new issues regarding the safety or effectiveness of theTITAN Reverse Shoulder System, and the modified device is as safeand effective as the predicate. |
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Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change
§ 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.”