(90 days)
Not Found
No
The summary describes a purely mechanical implant for bone fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is used in reconstruction procedures for the correction of lesser digits of the toes, which is a therapeutic intervention.
No
The device is described as a surgical implant (fusion device) used for correction procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical implant made of 316LVM Stainless Steel, which is a hardware component.
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 testing is done outside of the body (in vitro).
- Device Description: The StarFuse Interphalangeal Pin is a physical implant made of stainless steel, designed to be surgically placed inside the body to fuse bones in the toes.
- Intended Use: The intended use is for surgical procedures (osteotomies, arthrodeses, reconstruction) involving the correction of toe deformities. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly describes a surgical implant, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The StarFuse Interphalangeal Pin is a fusion device available in a range of profile diameters and lengths as well as straight or pre-bent options. Implants are made from 316LVM Stainless Steel per ASTM F138 and range in size from 3 to 4 mm in diameter and 16 to 30 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser digits of the toes
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)
Static and dynamic 3-point bending testing (per ASTM 1264-14) confirmed that the Subject device performed as intended.
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
Image /page/0/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 image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
Phalanx Innovations % Ms. Cheryl Wagoner Principal Consultant Wagoner Consulting LLC P.O. Box 15729 Wilmington, North Carolina 28408
Re: K160194
Trade/Device Name: StarFuse Interphalangeal Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 8, 2016 Received: April 11, 2016
Dear Ms. Wagoner:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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" (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
510(k) Number (if known) K160194
Device Name StarFuse Interphalangeal Pin
Indications for Use (Describe)
The StarFuse Interphalangeal Pin is indicated for use with osteotomies, and reconstruction procedures involving the correction of the lesser digits of the toes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
(as required by 21 CFR 807.92)
| Date Prepared | April 8, 2016 |
|---|---|
| Manufacturer | Phalanx Innovations |
| Address | 200 Cobb Pkwy N |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| Contact Person | Daniel Lanois |
| General Manager | |
| Address | Phalanx Innovations |
| 200 Cobb Pkwy N | |
| Building 200, Suite 210 | |
| Marietta, GA 30062 | |
| Telephone | 888-404-3980 Ext 101 |
| Fax | 678-669-2188 |
| daniel@phalanxinnovations.com |
| Trade Name | StarFuse Interphalangeal Pin | |
|---|---|---|
| Common Name | Intramedullary Bone Fastener | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Smooth or threaded metallic bone fixation fastener | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3040 | |
| Product Code | HTY | |
| Name of Predicate Device | 510(k) # | Manufacturer |
| ARROW-LOK Digital Fusion System | K112675 | Arrowhead Medical Device Technologies, LLC |
| Description | |
|---|---|
| The StarFuse Interphalangeal Pin is a fusion device available in a range | |
| of profile diameters and lengths as well as straight or pre-bent options. | |
| Implants are made from 316LVM Stainless Steel per ASTM F138 and | |
| range in size from 3 to 4 mm in diameter and 16 to 30 mm in length. |
| Indications and
| Intended Use | StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes. |
|---|---|
| --------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Subject device, is
substantially equivalent to the Predicate ARROW-LOK Digital Fusion
System (K112675). The Subject device is substantially equivalent to the
predicate device in intended use, indications for use, materials,
technological characteristics, performance and labeling. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Static and dynamic 3-point bending testing (per ASTM 1264-14)
confirmed that the Subject device performed as intended. |
| Conclusion | Based on the intended use, indications for use, technological
characteristics, materials, and comparison to predicate device, the
Subject device has been shown to be substantially equivalent to legally
marketed predicate devices. |