(119 days)
No
The description focuses on mechanical components and testing, with no mention of AI, ML, image processing, or data-driven decision making.
No.
Explanation: The device is an orthopedic implant system designed for mechanical fixation of small bone fusions, fractures, and inter-digital fusions. It functions as a structural support rather than providing therapy, treatment, or rehabilitation.
No
The device description indicates it is a system of intramedullary bone screws and instruments for permanent bone fusion, implying a therapeutic rather than diagnostic purpose. There is no mention of it being used to detect, monitor, or diagnose a condition.
No
The device description explicitly states it consists of physical components like intramedullary bone screws, a taper lock pin, and instruments, all made of metal alloys. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states that this device is a system of intramedullary bone screws and instruments used for surgical procedures (bone fusion, fracture fixation). It is implanted directly into the body.
- Intended Use: The intended use is for surgical fixation of bones, not for testing samples from the body.
The device described is a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
Product codes
HWC
Device Description
The Arthrosurface Inc's Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The taper lock pin provides a press fit connection between the two screws with light contact pressure. The implant components are manufactured using implant grade titanium alloy and cobaltchrome alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers, toes and small bones
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)
Comparative Mechanical Testing was performed per relevant recognized standards. Results from static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque and axial disassembly force tests along with comparative dimensional analyses were used to support equivalence to predicate devices. Data from cadaveric testing were also reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Section 5 510(k) Summary
| 510(k) Owner: | Arthrosurface, Inc.
28 Forge Parkway
Franklin, MA 02038
Tel: 508.520.3003
Fax: 508.528.4604
JUL 2 5 2013 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dawn Wilson
VP, Quality & Regulatory |
| Date of Preparation: | March 26, 2013 |
| Trade Name: | Hammertoe Correction System |
| Common Name: | Intramedullary Bone Screw |
| Device: | Screw, Fixation, Bone |
| Regulation Description: | Smooth or threaded metallic bone fixation
fastener |
| Regulation Number: | 888.3040 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | HWC |
Intended Use
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
Device Description
The Arthrosurface Inc's Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The taper lock pin provides a press fit connection between the two screws with light contact pressure. The implant components are manufactured using implant grade titanium alloy and cobaltchrome alloy.
1
Substantial Equivalency
The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the following previously cleared and commercially marketed devices:
| • Nextremity Solutions, LLC
| FlexFusion™ Fixation Implant | K110445 |
|---|---|
| • Wright Medical Technology, Inc. | |
| PRO-TOE™ VO Hammertoe Implant System | K101165 |
- K990804 Tornier, Inc. . . StayFuse
Comparative Mechanical Testing was performed per relevant recognized standards. Results from static and dynamic cantilever bending, torque to failure, pull-out force, insertion-removal torque and axial disassembly force tests along with comparative dimensional analyses were used to support equivalence to predicate devices. Data from cadaveric testing were also reported.
The fundamental scientific technology of the proposed device has not changed relative to the predicate devices.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2013
Arthrosurface, Incorporated % Ms. Dawn Wilson Vice President, Quality & Regulatory 28 Forge Parkway Franklin, Massachusetts 02038
Re: K130859
Trade/Device Name: Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 6, 2013 Received: June 11, 2013
Dear Ms. Wilson:
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
3
Page 2 - Ms. Dawn Wilson
forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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/ResourcesforYou/Industry/dcfault.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 Indications for Use Statement $ 1
510(k) Number (if known): _K130859
Device Name: Hammertoe Correction System
Indications for Use:
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | ________________________________ |
|---|---|
| ------------------------------------------------- | ---------------------------------- |
AND/OR
| Over-The-Counter
| (21 CFR 8) | |
|---|---|
| -------------------------------- | -- |
Counter Use 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori A. Wiggins
Division of Orthopedic Devices
Page 1 of 1