(89 days)
Not Found
No
The summary describes a mechanical fixation system made of titanium alloy with no mention of software, image processing, or AI/ML terms.
Yes
The device is described as an "Intraosseous Fixation System" intended to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges," which are all medical conditions that the device aims to treat or manage. Therefore, it is a therapeutic device.
No
The device is described as an "Intraosseous Fixation System" intended to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges." This description indicates it is a therapeutic or surgical device used for repair, not for diagnosis.
No
The device description explicitly states that the device consists of "various size implants" manufactured from "implant grade titanium alloy," indicating it is a hardware device.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Intraosseous Fixation System is a physical implant made of titanium alloy that is surgically placed within the body to stabilize bones.
- Intended Use: Its purpose is to fix fractures, fusions, and osteotomies of the phalanges, which is a structural and mechanical function, not a diagnostic one based on analyzing bodily specimens.
The information provided clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Intraosseous Fixation System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
Indications for Use:
The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The Intraosseous Fixation System consists of various size implants to stabilize and aid in the fixation of fracture, fusions, and osteotomies of the phalanges. The implants are offered in different lengths and diameters. All implants are manufactured from implant grade titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges
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)
Mechanical 4 point bend testing was performed to establish substantial equivalence. No new issues of safety and effectiveness have been raised.
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.
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
§ 888.3040 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
K120/65 page 1 of 1
510(k) SUMMARY
. .
APR 1 7 2012
| Submitter Information | |
|---|---|
| Submitter's Name: | |
| Address: | OrthoHelix Surgical Designs, Inc. |
| 1065 Medina Rd, Suite 500 | |
| Medina, Ohio 44256 | |
| Telephone Number: | |
| Fax Number: | 330-869-9562 |
| 330-247-1598 | |
| Prepared By: | Amanda Martin & Jamey Price |
| Contact Person: | Derek Lewis |
| Date Prepared: | 12/30/2011 |
| Device Information | |
| Trade Name: | Intraosseous Fixation System |
| Common Name: | Fixation Device |
| Classification Name: | Pin, Fixation, Smooth |
| Device Classification: | Pin, Fixation, Smooth (Class II per 21 CFR 888.3040) |
| Panel: Orthopedic, Product Code: HTY | |
| Predicate Device: | The Intraosseous Fixation System is equivalent to current legally |
| marketed devices. | |
| Material Composition: | Titanium Alloy |
| Device Description: | The Intraosseous Fixation System consists of various size implants to |
| stabilize and aid in the fixation of fracture, fusions, and osteotomies of | |
| the phalanges. The implants are offered in different lengths and | |
| diameters. All implants are manufactured from implant grade | |
| titanium alloy. | |
| Intended Use: | The Intraosseous Fixation System is intended to stabilize and aid in the |
| fixation of fractures, fusions, and osteotomies of the phalanges. | |
| Substantial Equivalence: | The Intraosseous Fixation System is substantially equivalent to the |
| New Deal K-wire (K022599) and Memometal Technologies Smart Toe | |
| (K070598). Mechanical 4 point bend testing was performed to | |
| establish substantial equivalence. No new issues of safety and | |
| effectiveness have been raised. |
1
Image /page/1/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three lines instead of one.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development 1065 Medina Road, Suite 500 Medina, Ohio 44256
APR 1 7 2012
Re: K120165
Trade/Device Name: Intraosseous Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: March 16, 2012 Received: March 19, 2012
Dear Mr. Lewis:
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 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.
2
Page 2 - Mr. Derek Lewis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Erin Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
3
K 120/65 page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: Intraosseous Fixation System
Indications for Use:
The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.
Over-The-Counter-Use Prescription Use ___ AND/OR × (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120605