(198 days)
Not Found
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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," which describes a therapeutic purpose.
No.
This device is an implantable orthopedic system (TITAN Reverse Shoulder System) designed for total shoulder replacement, not a device used to diagnose medical conditions. Its purpose is to replace a diseased or damaged joint.
No
The device description clearly outlines physical components like humeral stems, reverse bodies, poly liners, glenoid baseplates, screws, and glenospheres, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the TITAN Reverse Shoulder System is a surgical implant used for total shoulder replacement. It is a physical device implanted into the body to restore function to a damaged joint.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is therapeutic and reconstructive.
Therefore, the TITAN Reverse Shoulder System falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
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 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.
Product codes
PHX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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)
The TITAN Reverse Shoulder System has undergone the following performance testing to confirm the system's ability to perform under anticipated clinical conditions.
-
Dynamic Evaluation of RSS Glenoid Component Loosening or Disassociation
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 has no effect on the implant fatigue strength. -
Evaluation of RSS Implant Titanium Plasma Spray Coating
The coating meets 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 performance data demonstrate that the coating change does not raise any new issues regarding the safety or effectiveness of the TITAN Reverse Shoulder System, and the modified device is as safe and effective as the predicate.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.”
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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);
1
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
2
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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3
Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change
Section 7: 510(k) Summary
| Sponsor | Integra Lifesciences Corp.
311 Enterprise Drive
Plainsboro, NJ 08536 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Number | 1651501 |
| Point of Contact | Kathleen McGuire
Associate, Regulatory Affairs
609-936-7916
311 Enterprise Drive
Plainsboro, NJ 08536 |
| Date | December 4, 2017 |
| Trade Name | Integra TITAN Reverse Shoulder System |
| Common Name | Reverse Total Shoulder |
| Classification
Panel | 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-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 |
| Intended Use | 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. |
| Comparison to
Predicate | 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 coating
on the implant baseplate and body has been changed from vacuum-
sintered titanium Asymmatrix™ to titanium plasma spray. |
| Nonclinical
Performance Data | The TITAN Reverse Shoulder System has undergone the following
performance testing to confirm the system's ability to perform under
anticipated clinical conditions.
- Dynamic Evaluation of RSS Glenoid Component Loosening
or Disassociation
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 has no effect on the implant fatigue
strength. - Evaluation of RSS Implant Titanium Plasma Spray Coating
The coating meets 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". |
| Clinical
Performance Data | 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. |
| Conclusions
Drawn from
Performance Data | The performance data demonstrate that the coating change does not
raise any new issues regarding the safety or effectiveness of the
TITAN Reverse Shoulder System, and the modified device is as safe
and effective as the predicate. |
4
Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change