(120 days)
No
The description focuses on the mechanical components and intended use of a shoulder implant system, with no mention of AI or ML capabilities.
Yes
Explanation: The device is a total shoulder replacement system designed to relieve pain and disability due to gross rotator cuff deficiency, which directly addresses a medical condition and restores function.
No
The device is a reverse shoulder replacement system, intended to treat severe arthropathy and rotator cuff deficiency by replacing the joint, not to diagnose a medical condition.
No
The device description clearly outlines physical components like humeral stems, bodies, poly liners, glenoid baseplates, screws, and glenospheres, indicating it is a hardware-based implant system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a prosthetic shoulder joint (stems, bodies, liners, baseplate, glenosphere). These are physical implants used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis.
- Anatomical Site: The device is used directly within the shoulder joint, not for testing samples taken from the body.
- Performance Studies: The performance studies mentioned relate to cleaning validations and endotoxin testing, which are relevant to the safety and sterility of a surgical implant, not the diagnostic accuracy of a test.
In vitro diagnostics are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Titan Reverse Shoulder System is a surgical implant used to treat a condition (severe arthropathy or failed joint replacement) by replacing the damaged joint.
N/A
Intended Use / Indications for Use
The Titan Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously 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.
Product codes
PHX
Device Description
The Integra TITAN Reverse Shoulder System is a semi-constrained modular total shoulder construct. The humeral components consist of humeral stems, varying heights of reverse bodies, 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 4 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
No additional verification and validation test data were required as part of this submission. This 510(k) was submitted to expand the current INTEGRA® TITAN™ Reverse Shoulder System to include fracture indications. The Integra® TITANTM Reverse Shoulder System cleaning validations for both sterile and non-sterile products incorporate endotoxin (LAL) testing that is performed in accordance with standards AAMI ST72 and United States Pharmacopeia (USP) Chapter
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ascension® TITAN™ Reverse Shoulder System Glenoid (K130050)
Reference Device(s)
Lima SMR Reverse Shoulder System (K110598), Tornier Aequalis Reversed Fracture (K112144)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2016
Integra LifeSciences Corporation Mr. William Garzon Senior Regulatory Affairs Specialist 8700 Cameron Road, Suite 100 Austin, Texas 78754
Re: K161189
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: August 5, 2016 Received: August 8, 2016
Dear William Garzon:
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,
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):
Device Name:
INTEGRA® TITAN™ Reverse Shoulder System
Indications For Use:
The Titan Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previously 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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| 807.92(a)(1) – Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro NJ 08536 | |
| Name of Contact Person | William Garzon |
| Phone Number | (512) 596-8908 |
| Fax Number | (512) 836-6933 |
| Establishment | |
| Registration Number | 1651501 |
| Date Prepared | April 26, 2016 |
| 807.92(a)(2) – Name of device | |
| Trade or Propriety Name | INTEGRA® TITANTM Reverse Shoulder System-Fracture |
| Indications | |
| Common or Usual Name | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer |
| Cemented | |
| Classification Name | Shoulder joint metal/polymer semi-constrained cemented |
| prosthesis | |
| Classification Panel | Orthopedic |
| Regulation | Class II (under 21CFR 888.3660) |
| Product Code | PHX |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed |
510(k) Summary
Primary Predicate: Ascension® TITAN™ Reverse Shoulder System Glenoid ● (K130050)
- Reference Device: Lima SMR Reverse Shoulder System (K110598)
- . Reference Device Tornier Aequalis Reversed Fracture (K112144)
807.92(a)(4) - Device description
The Integra TITAN Reverse Shoulder System is a semi-constrained modular total shoulder construct. The humeral components consist of humeral stems, varying heights of reverse bodies, 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 4 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.
807.92(a)(5) - Intended Use of the device
| Indications for Use | The Titan Reverse Shoulder System is indicated for use in a
grossly deficient rotator cuff joint with severe arthropathy or a
previously 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 |
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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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.
807.92(a)(6) Comparison to Predicate Device(s)
The INTEGRA® TITAN™ Reverse Shoulder System-fracture indications is the exactly the same as the predicate in terms of materials, form and function. No changes in technology or packaging have been made to the predicate device. Only the labeling has been changed to add the fracture indication.
807.92(b)(1-2) – Nonclinical Tests Submitted
No additional verification and validation test data were required as part of this submission. This 510(k) was submitted to expand the current INTEGRA® TITAN™ Reverse Shoulder System to include fracture indications. The Integra® TITANTM Reverse Shoulder System cleaning validations for both sterile and non-sterile products incorporate endotoxin (LAL) testing that is performed in accordance with standards AAMI ST72 and United States Pharmacopeia (USP) Chapter
807.92(b)(3) - Conclusions drawn from non-clinical data
Based upon the predicate comparison to design features, materials, and use, the INTEGRA® TITAN™ Reverse Shoulder System does not raise any new questions of safety or effectiveness to include a fracture indication to the current indications for use. In the original INTEGRA® TITAN™ Reverse Shoulder System 510(k) K130050 cleared on June 18, 2013, Integra has shown that the device is substantially equivalent to the Lima Corporate SMR Reverse Shoulder System that has a fracture indication.