(153 days)
No
The summary describes a mechanical implant (glenoid component) and its intended use and performance testing, with no mention of AI or ML technology.
Yes
This device, a glenoid component for total shoulder arthroplasty, is used to treat severely painful and disabled joints resulting from arthritis or fractures, and it resurfaces the glenoid fossa to improve joint function. This directly serves a therapeutic purpose by alleviating symptoms and restoring mobility.
No
The device is a glenoid component for total shoulder arthroplasty, which is a treatment (replacement) device, not a diagnostic tool. Its intended use and description explain it is used to resurface the glenoid fossa in patients with certain shoulder conditions.
No
The device description clearly states it is a physical implant (a glenoid component made of polyethylene) used in shoulder surgery, not software.
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 joint in the shoulder. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of polyethylene, designed to be surgically implanted. This is consistent with a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical properties and wear characteristics of the implant, which are relevant to its function as a surgical device.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The INTEGRA® TITAN™ Modular System Fin-Lock™ Glenoid is intended for use in 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)
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
Device Description
The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs and three peripheral pegs. The articulating surface of the glenoid device will be the same dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder Joint / glenoid fossa / proximal humerus
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)
Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System Fin-lock™ Glenoid included the following:
- Rocking and Subluxation Characterization Test
- Glenoid Pull-out Fixation Test
- Extensively Cross-Linked UHMWPE Material Characterization Test
- Extensively Cross-Linked UHMWPE Wear Test
The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is substantially equivalent to the predicate devices 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.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, overlapping to create a sense of unity and connection. The symbol is meant to represent the department's focus on health and human well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2015
Integra LifeSciences Corporation Mr. William Garzon Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536
Re: K152047
Trade/Device Name: INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: November 24, 2015 Received: November 27, 2015
Dear Mr. Garzon:
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
1
forth in the quality systems (QS) 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,
Casey Hanley -S
- Mark 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) K152047
Device Name
INTEGRA® TITAN™M Modular Total Shoulder System Fin-Lock™ Glenoid
Indications for Use (Describe)
The INTEGRA® TITAN™ Modular System Fin-Lock™ Glenoid is intended for use in 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)
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)
| ☒ Transportation Use in CFR 229.301(a) | ☐ For Other Use in CFR 229.301(a) |
|---|---|
| ---------------------------------------------------------------------------------------- | ----------------------------------- |
|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."
3
| 807.92(a)(1) – Submitter Information | |
|---|---|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive |
| Plainsboro NJ 08536 | |
| Name of Contact Person | William Garzon |
| Phone Number | (512) 596-8908 |
| Fax Number | (512) 836-6933 |
| Establishment | |
| Registration Number | 1651501 |
| Date Prepared | December 22, 2015 |
| 807.92(a)(2) – Name of device | |
| Trade or Propriety Name | INTEGRA® TITAN™ Modular Total Shoulder System Fin- |
| Lock™ Glenoid | |
| 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 |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| • | Ascension® TITAN™ Modular Total Shoulder System Glenoid (K100448) – |
| Primary Predicate | |
| • | DePuy Anchor Peg Glenoid (K052472) – Reference Device |
| • | Tornier Affiniti Glenoid (K103007) – Reference Device |
| 807.92(a)(4) - Device description | |
| The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully | |
| cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty | |
| for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs | |
| and three peripheral pegs. The articulating surface of the glenoid device will be the same | |
| dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline | |
| glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of | |
| the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral | |
| component. | |
| 807.92(a)(5) – Intended Use of the device | |
| Indications for Use | The INTEGRA® TITAN™ Modular Total Shoulder System Fin- |
| Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty | |
| which is indicated for: |
- 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)
The humeral component is intended for cemented or uncemented
use.
The glenoid component is intended for cemented use only. |
510(k) Summary
4
807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate
The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is similar in design and materials to the predicate device, Ascension® TITAN™Modular Total Shoulder System (K100448). The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid has similar indications for use, intended use and fundamental scientific technology as its predicate.
The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is similar in central peg length to the predicate devices, DePuy Anchor Peg Glenoid (K052472) and Tornier Affiniti Glenoid (K103007).
The differences between the predicates and proposed device do not raise any new issues regarding safety and effectiveness; therefore, the INTEGRA® TITAN™M Modular Total Shoulder System Fin-Lock™ Glenoid 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 Fin-lock™ Glenoid included the following:
- Rocking and Subluxation Characterization Test ●
- Glenoid Pull-out Fixation Test ●
- Extensively Cross-Linked UHMWPE Material Characterization Test ●
- Extensively Cross-Linked UHMWPE Wear Test
The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is substantially equivalent to the predicate devices 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.