(270 days)
Not Found
No
The document describes a mechanical implant system and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement, and for the relief of pain and significant disability due to gross rotator cuff deficiency, which are therapeutic purposes.
No
This device is a total shoulder construct designed for joint replacement, not for diagnosing conditions. Its purpose is to treat severe arthropathy or failed joint replacements by replacing the shoulder joint components.
No
The device description clearly outlines physical components like humeral stems, bodies, liners, glenoid baseplates, screws, and glenospheres, all of which are hardware implants. The performance studies also focus on engineering testing of these physical components.
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 device components (stems, bodies, liners, baseplate, glenosphere) are all physical implants designed to be surgically placed within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to diagnose a condition.
- Performance Studies: The performance studies focus on the mechanical properties and wear characteristics of the implant materials, which are relevant to the safety and efficacy of a surgical device, not a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a replacement for a damaged joint.
N/A
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.
Product codes
PHX
Device Description
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 implant scope of the RSS is being expanded to include additional options for humeral liners manufactured from highly crosslinked Ultra High Molecular Weight Polyethylene (XLPE) per ASTM F2565. The existing humeral liners are manufactured from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners.
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
Prescription Use
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)
Nonclinical Performance Data: The subject XLPE humeral liners have undergone the following engineering testing to establish substantial equivalence to the predicate humeral liners:
- Full Construct Fatigue Test, Standard: ASTM F1378, ASTM F1875, ASTM F2009
- Axial Disassembly Test, Standard: ASTM F1820
- Rotational Resistance Test
- Scapular Impingement Fatigue Test, Standard: ASTM F1820, ASTM F2003, ASTM F2582, ISO 14242-1, ISO 14242-2
- Wear Test and Analysis – XLPE vs. conventional UHMWPE, Standard: ASTM F732, ASTM F2025
Clinical Performance Data: Clinical performance data is not required to demonstrate substantial equivalence to the predicate RSS 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.”
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December 2, 2019
Integra LifeSciences Corporation Blesson Abraham Senior Regulatory Affairs Specialist 11101 Metric Blvd AUSTIN TX 78758
Re: K190588
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: November 1, 2019 Received: November 4, 2019
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/cfdocs/cfpmn/pmn.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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190588
Device Name
Integra TITAN Reverse Shoulder System
Indications for Use (Describe)
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.
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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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
Ph. No: 512-368-1423 |
| Date | March 6, 2019 |
| Trade Name | Integra TITAN Reverse Shoulder System |
| Common Name | Reverse Total Shoulder Orthopedic |
| 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 | K161189, Integra TITAN Reverse Shoulder System |
| Device Description | 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 implant scope of the RSS is being expanded to include additional options for humeral liners manufactured from highly crosslinked Ultra High Molecular Weight Polyethylene (XLPE) per ASTM F2565. The existing humeral liners are manufactured from conventional UHMWPE per ASTM F648. The change in material allows for improved wear characteristics of the humeral liners. |
| 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 |
4
| Nonclinical
Performance Data | The subject XLPE humeral liners have undergone the following engineering
testing to establish substantial equivalence to the predicate humeral liners. | | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------|
| | No. | Testing Description | Standard |
| | 1 | Full Construct Fatigue Test | ASTM F1378
ASTM F1875
ASTM F2009 |
| | 2 | Axial Disassembly Test | ASTM F1820 |
| | 3 | Rotational Resistance Test | |
| | 4 | Scapular Impingement Fatigue Test | ASTM F1820
ASTM F2003
ASTM F2582
ISO 14242-1
ISO 14242-2 |
| | 5 | Wear Test and Analysis – XLPE vs. conventional
UHMWPE | ASTM F732
ASTM F2025 |
| Clinical
Performance Data | Clinical performance data is not required to demonstrate substantial
equivalence to the predicate RSS device. | | |
| Substantial
Equivalence
Conclusion | Substantial equivalence of the subject humeral liner and predicate humeral
liner is based on the following:
• Both devices have the same intended use.
• Both devices operate using the same fundamental scientific technology.
• Both devices share the same functional and technological characteristics
via the same operational principles.
Evaluation of the risks and performance data referenced in this 510(k)
submission demonstrate that the subject humeral liners are safe and effective
for their intended use and substantially equivalent to the cited predicate
humeral liners. | | |