(21 days)
No
The summary describes a bioabsorbable implant for soft tissue fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an implant for soft tissue and bone fixation, which treats injuries, making it a therapeutic device.
No
The device is described as an implant for soft tissue reattachment, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a bioabsorbable implant consisting of physical components (tip, sleeve, and pin) intended for surgical fixation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The Titan RC Tack is described as a "bioabsorbable implant intended for soft tissue reattachment to host bone." It is a physical device implanted into the body to fix tissues.
- Intended Use: The intended use is for "soft tissue to bone fixation" in specific anatomical locations (shoulder, knee, ankle) for various repair procedures. This is a surgical intervention, not a diagnostic test performed on a specimen.
The description clearly indicates a surgical implant used for structural repair within the body, which is fundamentally different from an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Titan RC Tack is intended for fixation of soft tissue to bone for the following indications:
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair
KNEE
Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis
ANKLE
Lateral and medial instability Achilles tendon reconstruction and repair
Product codes
MAI
Device Description
The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, ankle
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
Bone Model Testing: the ultimate holding strength at 3, 6, and 12 weeks in-vitro.
The testing demonstrates substantially equivalent performance between the two devices
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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Image /page/0/Picture/1 description: The image shows the logo for Innovative Devices. The logo consists of a stylized letter "A" on the left, followed by the word "INNOVATIVE" in bold, sans-serif font. Below the word "INNOVATIVE" is the word "DEVICES" in a smaller font size.
JAN 1 0 2000
510(K) SUMMARY
1. SUBMITTER:
Innovasive Devices, Inc. 734 Forest St. Marlborough, MA 01752 Telephone: 508-460-8229 Fax: 508-460-6661
Contact: Kathleen Morahan, Regulatory Affairs Specialist Date Prepared: December 17, 1999
2. DEVICE:
Trade Name: Innovasive Titan RC Tack Common Name: Bone Anchor Class: II Classification Name: "Single/Multiple Component Bone Fixation Appliances and Accessories"
3. PREDICATE DEVICE:
Innovasive RC Tack (K992377)
4. DEVICE DESCRIPTION:
The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.
5. INTENDED USE:
The Titan RC Tack is intended for fixation of soft tissue to bone for the following indications:
1
1082
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair
KNEE
Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis
ANKLE
Lateral and medial instability Achilles tendon reconstruction and repair
6. COMPARISON OF CHARACTERISTICS:
The proposed Titan RC Tack, is a bioabsorbable version of the predicate RC Tack, and is therefore similar in design. The proposed device is molded from L-PLA with a color additive for implant visibility. The predicate device is molded from Delrin and HDPE. The proposed and predicate devices utilize the same method of bone fixation: radial expansion of the sleeve. Lastly, the indications being requested for the proposed Titan RC Tack are already cleared for the predicate RC Tack.
7. PERFORMANCE DATA:
The following performance data was proved in support of the substantial equivalence determination:
Bone Model Testing: the ultimate holding strength at 3, 6, and 12 weeks in-vitro.
The testing demonstrates substantially equivalent performance between the two devices
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 0 2000
Ms. Kathleen Morahan Regulatory Affairs Specialist Innovasive Devices Incorporated 734 Forest Street Marlborough, Massachusetts 01752
Re: K994269 Titan RC Tack Product Code: MAI Regulatory Class: II Dated: December 17, 1999 Received: December 20, 1999
Dear Ms. Morahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thos. W. Hays.
- Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
The Titan RC Tack is intended for soft tissue to bone fixation for the following indications:
SHOULDER
Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair
KNEE
Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis
ANKLE
Lateral and medial instability Achilles tendon reconstruction and repair
Prescription Use
(Per 21 CFR 801.109)
Verrell Ingram or Jr
(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
510(k) Number ____________________________________________________________________________________________________