(125 days)
No
The description focuses on mechanical properties and intended use for bone fixation, with no mention of AI/ML or related concepts like image processing or data analysis.
Yes
Explanation: The device is indicated for "fixation of fractures, fusions, and osteotomies of bones of the hand and-foot," which are medical conditions, and its purpose is to treat or alleviate these conditions.
No
Explanation: The device is a screw system indicated for fixation of fractures, fusions, and osteotomies. It is used for treatment/stabilization rather than diagnosis.
No
The device description explicitly states the system consists of "screws of various diameters, lengths and thread configurations," which are physical hardware components. The performance studies also describe mechanical testing of these physical screws.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of fractures, fusions, and osteotomies of bones of the hand and foot." This describes a surgical implant used to physically stabilize bone structures.
- Device Description: The device is described as a "system consists of screws of various diameters, lengths and thread configurations." This further confirms it's a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, analyzers, or test kits.
Therefore, the Tornier ForeFoot STP Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.
Product codes
HWC
Device Description
The submission is regarding the ForeFoot STP System. This system consists of screws of various diameters, lengths and thread configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand and foot
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
Cross-sectional bending analysis and mechanical axial pull-out testing comparing the strength of the subject and predicate devices was performed and the results support substantial equivalence. Mechanical testing was completed to ensure that the torsional strength, insertion torque, and removal torque are appropriate for the potential applications of the device.
Key Metrics
Not Found
Predicate Device(s)
K014154, K052576, K131324, K053394
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other.
August 4, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Tornier, Incorporated Brian Hockett Director of Research and Development- Lower Extremity 1065 Medina Road, Suite 500 Medina. Ohio 44256
Re: K150871
Trade/Device Name: ForeFoot STP System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: July 2, 2015 Received: July 6, 2015
Dear Mr. Hockett:
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 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.
1
Page 2 - Mr. Brian Hockett
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" (21 CFR 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K150871
Device Name ForeFoot STP System
Indications for Use (Describe)
The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, fusions, and osteotomies of bones of the hand and foot.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Submitter Information
| Submitter's Name: | Tornier, Inc. |
|---|---|
| Address: | 1065 Medina Rd, Suite 500 |
| Medina, Ohio 44256 | |
| Telephone Number: | 330-869-9562 |
| Fax Number: | 330-247-1598 |
| Prepared By: | Liz Altenau, Andy Leither |
| Contact Person: | Brian Hockett |
| Date Prepared: | 3/12/2015 |
| Device Information | |
| Trade Name: | ForeFoot STP System |
| Common Name: | Fixation Screws |
| Classification Name: | Screw, Fixation, Bone |
| Device Classification: | Smooth or threaded metallic bone fixation fastener |
| Class II per 21 CFR 888.3040 | |
| Panel: Orthopedic, Product Code: HWC | |
| Material Composition: | Titanium Alloy |
| Primary Predicate Device: | Vilex/Duval/Orthex Cannulated Bone Screw Double Thread, K014154 |
| Additional Predicate Devices: | SBI AutoFix System, K052576 |
| OrthoHelix MaxTorque System, K131324 | |
| Nexa Bone Screw System, K053394 | |
| Device Description: | The submission is regarding the ForeFoot STP System. This system consists of |
| screws of various diameters, lengths and thread configurations. | |
| Indications for Use: | The Tornier ForeFoot STP Screw System is indicated for fixation of fractures, |
| fusions, and osteotomies of bones of the hand and foot. | |
| Substantial Equivalence: | The Tornier ForeFoot STP screws are substantially equivalent to the previously |
| cleared predicate devices. Cross-sectional bending analysis and mechanical | |
| axial pull-out testing comparing the strength of the subject and predicate | |
| devices was performed and the results support substantial equivalence. | |
| Mechanical testing was completed to ensure that the torsional strength, | |
| insertion torque, and removal torque are appropriate for the potential | |
| applications of the device. Due to similarities in indications, design, and | |
| materials, no other testing was required; therefore, the subject device was | |
| demonstrated to be as safe and effective as the above predicates. |