(78 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for shoulder replacement. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical testing of the components.
Yes.
The device is indicated for total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency, which is a therapeutic purpose.
No
Explanation: The provided text describes a "TITAN Reverse Shoulder System" which is a surgical implant used for total shoulder replacement. Its intended use is for treating severe arthropathy or failed joint replacements, and it is a device designed for therapeutic intervention, not for diagnosing a condition.
No
The device description clearly outlines physical components like humeral stems, glenoid baseplates, and screws, indicating it is a hardware-based medical device.
Based on the provided information, the TITAN Reverse Shoulder System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used for total shoulder replacement in patients with specific conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the components of a surgical implant (stems, bodies, liners, baseplate, glenosphere, screws). These are physical devices implanted into the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are typically used for diagnosis, monitoring, or screening based on analysis of biological samples.
- Performance Studies: The performance studies described are engineering tests evaluating the mechanical properties and durability of the implant components, not studies evaluating the accuracy or reliability of diagnostic measurements from biological samples.
In summary, the TITAN Reverse Shoulder System is a surgical implant, not a device used for in vitro diagnostic testing.
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 (comma separated list FDA assigned to the subject device)
PHX
Device Description
Integra TITAN Reverse Shoulder System. The Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral 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 cemented and cementless use. The scope of the RSS is being expanded via a line extension to include additional options for baseplates, glenospheres, and screws. The baseplate option features a smaller post in comparison to the currently commercialized baseplate options, along with glenospheres that work in conjunction with the baseplate. The baseplate under this line extension is referred to as the Small Post Baseplate (SPB). Additional Star screw options have also been incorporated as part of the line extension.
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 Integra TITAN Reverse Shoulder System (RSS) line extension components (Small Post Baseplate, SPB Glenospheres, and Star Screws) have undergone the following engineering testing to establish substantial equivalence in comparison to the predicate system components:
No. 1: SPB & Glenosphere - Axial Taper Disassembly Test, Standard: ASTM F2009
No. 2: SPB & Glenosphere - Taper Torsion Test
No. 3: All Implants - Full Construct Fatigue Test, Standard: ASTM F1378 ASTM F1875
No. 4: SPB - Dynamic Evaluation of Glenoid Loosening or Disassociation Test, Standard: ASTM F2028
No. 5: Screws - Torsional Properties Test, Standard: ASTM F543
No. 6: Screws - Axial Pullout Strength Test
Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device. Evaluation of the risks and performance data of the subject device does not raise any new issues or concerns related to safety or effectiveness. We have concluded that the subject device components (the Small Post Baseplate, SPB Glenospheres, and Star Screws) are as safe and effective as the predicate RSS device components (Baseplates, Glenospheres, and Screws) for its intended use, and that the system is substantially equivalent to the legally marketed predicate device, the Integra TITAN Total Reverse Shoulder System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 ADMINISTRATION" in blue text.
October 12, 2018
Integra Lifesciences Corporation Blesson Abraham Senior Regulatory Affairs Specialist 11101 Metric Blvd. Austin, Texas 78758
Re: K181999
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 10, 2018 Received: August 13, 2018
Dear Blesson 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. 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/ofdocs/ofpmn.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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Vesa Vuniqi -S. The document was signed on October 12, 2018 at 12:06:16 -04'00'.
Mark N. Melkerson For: 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)
K181999
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 150 of 347
3
Integra Lifesciences Corporation
Integra TITAN Reverse Shoulder System – Line Extension
Image /page/3/Picture/2 description: The image shows the Integra logo. The word "INTEGRA" is written in gray, and the words "LIMIT UNCERTAINTY" are written in green below it. To the right of the word "INTEGRA" are four green squares of varying sizes.
510(k) Summary
| Sponsor | Integra Lifesciences Corp.
Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin, TX 78758 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Number | 3014207283 |
| Point of Contact | Blesson Abraham
Senior Regulatory Affairs Specialist
11101 Metric Blvd.
Austin, TX 78758
512-368-1423 |
| Date | July 25, 2018 |
| Trade Name | Integra TITAN Reverse Shoulder System |
| Common Name | Reverse Total Shoulder |
| Classification
Panel | Orthopedic |
| Classification | Class II |
| Regulation No. | 21 CFR 888.3660 |
| Regulation Name | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Product Code | PHX |
| Predicate Device | K173717 |
| Device
Description | Integra TITAN Reverse Shoulder System. The Integra TITAN Reverse Shoulder System (RSS) is a semi-constrained total shoulder construct. The humeral components consist of humeral stems, reverse bodies of varying heights, and humeral liners. The humeral 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 cemented and cementless use. The scope of the RSS is being expanded via a line extension to include additional options for baseplates, glenospheres, and screws. The baseplate option features |
4
| a smaller post in comparison to the currently commercialized baseplate options, along with glenospheres that work in conjunction with the baseplate. The baseplate under this line extension is referred to as the Small Post Baseplate (SPB). Additional Star screw options have also been incorporated as part of the line extension. | |||
|---|---|---|---|
| Intended Use/Indications for Use | The Integra 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. | ||
| Nonclinical | |||
| Performance Data | The Integra TITAN Reverse Shoulder System (RSS) line extension components (Small Post Baseplate, SPB Glenospheres, and Star Screws) have undergone the following engineering testing to establish substantial equivalence in comparison to the predicate system components. | ||
| No. | Testing Description | Standard | |
| 1 | SPB & Glenosphere - Axial Taper Disassembly Test | ASTM F2009 | |
| 2 | SPB & Glenosphere - Taper Torsion Test | ||
| 3 | All Implants - Full Construct Fatigue Test | ASTM F1378 | |
| ASTM F1875 | |||
| 4 | SPB - Dynamic Evaluation of Glenoid Loosening or | ||
| Disassociation Test | ASTM F2028 | ||
| 5 | Screws - Torsional Properties Test | ASTM F543 | |
| 6 | Screws - Axial Pullout Strength Test | ||
| Clinical | |||
| Performance Data | Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS device. |
5
| Evaluation of the risks and performance data of the subject device does not raise | |
|---|---|
| any new issues or concerns related to safety or effectiveness. We have | |
| concluded that the subject device components (the Small Post Baseplate, SPB | |
| Glenospheres, and Star Screws) are as safe and effective as the predicate RSS | |
| device components (Baseplates, Glenospheres, and Screws) for its intended use, | |
| and that the system is substantially equivalent to the legally marketed predicate | |
| device, the Integra TITAN Total Reverse Shoulder System. |