(103 days)
Not Found
No
The document describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is used for the treatment of fractures, which is a medical condition, making it a therapeutic device.
No
The device is an intramedullary implant used for internal fixation of ulna fractures. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is an "intramedullary device" made from titanium alloy and Nitinol, which are hardware components. The performance studies also focus on physical properties and testing of a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of distal or proximal ulna fractures." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details an "intramedullary device" that is "deployed into the medullary canal" to "provide a scaffold to which bone fragments are attached." This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening
This device is a surgical implant used for internal fixation of bone fractures.
N/A
Intended Use / Indications for Use
The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HSB
Device Description
The Conventus Orthopaedics Ulna Fixation System is an intramedullary device intended for distal and proximal ulna fractures. The Ulna Fixation System is a self-expanding implant which is deployed into the medullary canal and provides a scaffold to which bone fragments are attached using fragment screws. The implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal or proximal ulna
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)
This finding is supported by the following pre-clinical tests that have been performed:
- · Static and cyclic axial/bend testing
- · Static and cyclic torsional testing
- · Screw pullout testing
- · Corrosion testing
- · Wear testing
- · Nickel ion release testing
- Surface analysis testing
- · Nitinol phase composition
- · Nitinol transition temperature (Af)
- · Biocompatibility testing
- Animal Testing
- · MRI Testing
- · Kinetic Chromogenic Limulus Amebocyte Lysate testing (pyrogenicity)
The results demonstrate that the Ulna Fixation System is substantially equivalent to the legally marketed predicate devices.
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.
K000684, K073402, K102689, K131552, K151379
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
§ 888.3030 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
Conventus Orthopaedics, Incorporated Mr. Kent R. Lind Vice President, Quality, Regulatory, Clinical 10200 73rd Avenue North, Suite 122 Maple Grove, Minnesota 55369
Re: K161048
Trade/Device Name: Conventus Orthopaedics Ulna Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HSB Dated: June 20, 2016 Received: June 21, 2016
Dear Mr. Lind:
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 Parts 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 (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/ResourcesforYou/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,
Vincent J. Devlin -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) K161048
Device Name Conventus Orthopaedics Ulna Fixation System
Indications for Use (Describe)
The Conventus Orthopaedics Ulna Fixation System is indicated for treatment of distal or proximal ulna fractures when internal fixation is desired, and fracture fragments are not too numerous and/or too small to be stabilized with the use of the device.
| 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) |
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Company: | Conventus Orthopaedics, Inc.
10200 73rd Avenue North, Suite 122
Maple Grove, MN 55369 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Conventus Orthopaedics Ulna Fixation System |
| Device Common Name: | Ulna fracture fixation system |
| Contact: | Kent R. Lind
Vice President, Quality, Regulatory, Clinical
Phone: (763) 515-5003
Fax: (763) 315-4980 |
| Date Prepared: | July 01, 2016 |
| Classification: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories
21 CFR 888.3020: Intramedullary fixation rod |
| Class: | II |
| Product Codes: | HRS and HSB |
| Indications for Use: | The Conventus Orthopaedics Ulna Fixation System is indicated for
treatment of distal and proximal ulna fractures when internal
fixation is desired, and fracture fragments are not too numerous
and/or too small to be stabilized with the use of the device. |
| Device Description: | The Conventus Orthopaedics Ulna Fixation System is an
intramedullary device intended for distal and proximal ulna
fractures. The Ulna Fixation System is a self-expanding implant
which is deployed into the medullary canal and provides a scaffold
to which bone fragments are attached using fragment screws. The
implant is made from titanium alloy (Ti-6Al-4V ELI) and Nitinol. |
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Substantial Equivalence:
Conventus Orthopaedics has demonstrated that, for purposes of FDA's regulation of medical devices, the Conventus Orthopaedics Ulna Fixation System is substantially equivalent to the following devices that have been previously cleared by the FDA:
- · Primary predicate: Synthes T-Plate (Small Fragment Dynamic Compression Locking System) (K000684)
- · Synthes Olecranon Osteotomy Nailing System (K073402)
- · Conventus DRS™ System (K102689, K131552)
- · Conventus PRSTM System (K151379)
This finding is supported by the following pre-clinical tests that have been performed:
- · Static and cyclic axial/bend testing
- · Static and cyclic torsional testing
- · Screw pullout testing
- · Corrosion testing
- · Wear testing
- · Nickel ion release testing
- Surface analysis testing
- · Nitinol phase composition
- · Nitinol transition temperature (Af)
- · Biocompatibility testing
- Animal Testing
- · MRI Testing
- · Kinetic Chromogenic Limulus Amebocyte Lysate testing (pyrogenicity)
The results demonstrate that the Ulna Fixation System is substantially equivalent to the legally marketed predicate devices.