(78 days)
Not Found
No
The description focuses on the mechanical components and intended use of a shoulder implant system, with no mention of AI or ML technologies.
Yes.
The device is indicated for conditions such as osteoarthritis, rheumatoid arthritis, and fractures, which are diseases or injuries that cause pain and disability. The device is intended to treat these conditions by replacing or restoring a damaged joint, thus providing therapeutic benefits.
No
The device described is a total shoulder arthroplasty system, a prosthetic implant used for surgical replacement of the shoulder joint, not a tool for diagnosing medical conditions.
No
The device description clearly outlines physical components (metaphyseal bodies, humeral stems, humeral heads, glenoid components) and mentions testing related to the mechanical performance of these components (Taper Axial Disassembly Test, Fatigue Test, Maximum Static Load Test, Impact Assembly Test, Suture Verification Report). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the INTEGRA® TITAN™ Modular Total Shoulder System is a surgical implant used for total shoulder arthroplasty (joint replacement). It is physically implanted into the patient's body to replace a damaged shoulder joint.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is to restore function and alleviate pain in a damaged joint.
Therefore, the INTEGRA® TITAN™ Modular Total Shoulder System falls under the category of a surgical implant/prosthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INTEGRA® TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component) Shoulder Hemiathroplasty is also indicated for: Ununited humeral head factures, Avascular necrosis of the humeral head, Rotator cuff arthropathy, Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
KWS, HSD
Device Description
The TITAN™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads.
The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.
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)
Nonclinical Tests Submitted :
- Taper Axial Disassembly Test
- . Fatigue Test
- Maximum Static Load Test ●
- Impact Assembly Test
- Suture Verification Report ●
The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified.
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/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with a stylized eagle above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Ascension Orthopedics % Mr. Frederic Testa Regulatory Affairs Director Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K142413
Trade/Device Name: INTEGRA® TITAN™ Modular Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: September 15, 2014 Received: September 16, 2014
Dear Mr. Testa:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/Resourcesfor You/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 yours,
Lori A. Wiggins -S
for 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) K142413
Device Name
INTEGRA® TITAN™ Modular Total Shoulder System
Indications for Use (Describe)
The INTEGRA TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty which is indicated for: Severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component) Shoulder Hemiathroplasty is also indicated for: Ununited humeral head factures, Avascular necrosis of the humeral head, Rotator cuff arthropathy, Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 807.92(a)(1) – Submitter Information | |
|---|---|
| Name | Ascension Orthopedics, Inc. |
| Address | 8700 Cameron Road, Suite 100 |
| Austin, TX 78754 | |
| Name of Contact Person | Frederic Testa |
| Phone Number | (609) 936-3630 |
| Fax Number | (609) 275-9445 |
| Establishment Registration Number | 1651501 |
| Date Prepared | November 11th, 2014 |
| 807.92(a)(2) – Name of device | |
| Trade or Propriety Name | INTEGRA® TITAN™ Modular Total Shoulder System |
| Common or Usual Name | Shoulder Joint Metal/Polymer Semi-Constrained Cemented |
| Prosthesis | |
| Classification Name | Prostheses, Shoulder, Semi-Constrained, Metal/Polymer |
| Cemented | |
| Classification Panel | Orthopedic |
| Regulation | Class II (under 21CFR 888.3660) |
| Product Code | KWS, HSD |
510(k) Summary
Ascension® TITAN™ Modular Total Shoulder System (K112438)
807.92(a)(4) - Device description
The TITAN™ Modular Total Shoulder System consists of a line of metaphyseal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The metaphyseal bodies and humeral stems are shaped to provide proximal fixation and optimal fixation area. Their variable length and proximally-filling shape are designed to accommodate the natural humeral geometry and provide stable fixation. proximal bone loading and proper head placement. The humeral heads are offered with both concentric and eccentric articulating surfaces. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the all polyethylene cemented glenoid. The glenoid has multiple options: keeled or standard pegged (3 pegs). All glenoid options are designed to function with both the concentric and eccentric heads.
The humeral components are intended for cemented or uncemented use, while the glenoid component is for use with cement only.
| 807.92(a)(5) – Intended Use of the device | |
|---|---|
| Indications for Use | The INTEGRA® TITAN™ Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: |
4
| Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component) Shoulder Hemiarthroplasty is also indicated for: Ununited humeral head factures Avascular necrosis of the humeral head Rotator cuff arthropathy Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only. | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The INTEGRA® TITAN™ Modular Total Shoulder System is similar in design and materials to the predicate device, Ascension® TITAN™ Modular Total Shoulder System (K112438). The INTEGRA® TITAN™ Modular Total Shoulder System has similar indications for use, intended use and fundamental scientific technology as its predicate. The differences between the predicated and proposed device do not raise any new issues regarding safety and effectiveness; therefore, the INTEGRA® TITAN™ Modular Total Shoulder System is considered substantially equivalent to the predicate device.
807.92(b)(1-2) - Nonclinical Tests Submitted
Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System included the following:
- Taper Axial Disassembly Test
- . Fatigue Test
- Maximum Static Load Test ●
- Impact Assembly Test
- Suture Verification Report ●
The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System is safe for the intended use, and is substantially equivalent to the predicate device identified.
807.92(b)(3) - Conclusions drawn from non-clinical data
The design features, materials, intended use, and overall fundamental scientific technology of the INTEGRA® TITAN™ Modular Total Shoulder System are substantially equivalent to the predicate device. The safety and effectiveness of the INTEGRA® TITAN™ Modular Total Shoulder System is adequately supported by the substantial equivalence information, materials information, and performance data provided within this Premarket Notification submission.