(78 days)
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.
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.
The provided document is a 510(k) Premarket Notification summary for the INTEGRA® TITAN™ Modular Total Shoulder System. This document outlines the device description, intended use, and a comparison to a predicate device, focusing on demonstrating substantial equivalence rather than a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML device or a clinical trial.
The "acceptance criteria" and "device performance" described are related to non-clinical mechanical testing of the orthopedic implant, not to diagnostic accuracy or clinical outcomes in the way one would assess an AI/ML device. Therefore, many of the requested categories in your prompt are not applicable or cannot be extracted from this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of acceptance criteria and reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Taper Axial Disassembly Test | Not explicitly stated in the document, but can be inferred as meeting a predefined standard or benchmark for safe and effective performance of the taper connection. | "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..." |
| Fatigue Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the cyclic loading capability of the implant components, ensuring durability over time. | "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..." |
| Maximum Static Load Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the maximum force the device can withstand without failure. | "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..." |
| Impact Assembly Test | Not explicitly stated, but inferred as meeting a predefined standard or benchmark for the robust assembly of the modular components, likely involving resistance to impact forces during implantation or use. | "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..." |
| Suture Verification Report | Not explicitly stated, but inferred as ensuring that sutures, if any are part of the device or its intended use, function as designed and maintain structural integrity. This might be more related to surgical technique or a component of the implant. | "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..." |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of the non-clinical tests listed above. The document states: "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."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified for these non-clinical mechanical tests. Typically, mechanical testing involves a certain number of test articles (e.g., usually 3, 5, or more per test condition as per ISO or ASTM standards) rather than "patients" or "data sets." Specific quantities are not disclosed in this summary document.
- Data Provenance: N/A. These are laboratory-based mechanical tests performed on device components, not based on human data from a geographic origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM, ISO standards for orthopedic implants). It does not involve human expert interpretation in the way clinical diagnostic data would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This concept is for clinical data adjudication, not mechanical engineering tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This is a non-clinical 510(k) submission for a physical orthopedic implant, not an AI/ML diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For these mechanical tests, the "ground truth" is based on engineering specifications, material science principles, and established international or national standards for orthopedic implant mechanical performance (e.g., ASTM F2028-14 for humeral prostheses, or similar standards for fatigue, static loading, and taper connections). The "acceptance criteria" are derived from these standards and the predicate device's performance.
8. The sample size for the training set:
- N/A. There is no concept of a "training set" for physical mechanical device testing as there would be for an AI/ML algorithm. The design of the device is based on engineering principles and comparison to the predicate.
9. How the ground truth for the training set was established:
- N/A. Not applicable to this type of device and testing.
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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
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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
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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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| 807.92(a)(1) – Submitter Information | |
|---|---|
| Name | Ascension Orthopedics, Inc. |
| Address | 8700 Cameron Road, Suite 100Austin, 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 CementedProsthesis |
| Classification Name | Prostheses, Shoulder, Semi-Constrained, Metal/PolymerCemented |
| 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: |
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| 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.
§ 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.”