(89 days)
Not Found
No
The summary describes a mechanical implant for toe surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for fixation of osteotomies, arthrodeses, and reconstruction in the lesser toes following corrective procedures, which are therapeutic interventions.
No
The device description clearly states its purpose is for "fixation of osteotomies, arthrodeses and reconstruction in the lesser toes Rollowing corrective procedures." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states the device is an implant manufactured from stainless steel, indicating it is a physical hardware device, not software only.
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 about a person's health.
- Device Description: The ARROW-LOK Digital Fusion System is a surgical implant made of stainless steel, designed for fixation of bones in the lesser toes. It is physically implanted into the body.
- Intended Use: The intended use is for surgical procedures (fixation of osteotomies, arthrodeses, and reconstruction).
The device's function is to provide structural support and fixation within the body, not to analyze biological samples outside the body.
N/A
Intended Use / Indications for Use
The ARROW-LOK Digital Fusion System is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The ARROW-LOK Digital Fusion device features a three dimensional arrow shape. The implants are available in multiple lengths with arrowheads of various diameters and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser 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)
Substantial equivalence was shown through Rotational Forces Testing, Pull-out Testing and Four-Point Bend evaluations. The evaluations confirmed that the ARROW-LOK Digital Fusion System is at least equivalent to the 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.
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
Exhibit 2
510(k) Summary
DEC | 2 2011
KII2675
The 2.5mm Diameter ARROW-LOK Implant and the ARROW-LOK Hybrid Implant as Additions to the ARROW-LOK Digital Fusion System
| Submitted by: | Arrowhead Medical Device Technologies, LLC
328 Poplar View Lane East, Suite 2
Collierville, TN 38017 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 12, 2011 |
| Contact Person: | Thomas J. Twardzik
Vice President, Sales and Marketing
Office: (901) 853-4366
Fax: (206) 222-9173
Email: Tom@ArrowheadDevices.com |
| Proprietary Name: | ARROW-LOK Digital Fusion System |
| Common Name | Intramedullary Bone Fastener |
| Device
Classification
Regulation | 21 CFR 888.3040 (implants/instruments) - Class II |
| Device Product
Code and Panel | HTY: Pin, Fixation, Smooth
87 Orthopedics |
| Device Description | The ARROW-LOK Digital Fusion device features a three
dimensional arrow shape. The implants are available in multiple
lengths
with arrowheads of various diameters and in 2 different angles.
The implant is manufactured from stainless steel and is designed
for single use only. |
| Intended Use | The ARROW-LOK Digital Fusion System is indicated for fixation of
osteotomies, arthrodeses and reconstruction in the lesser toes
following corrective procedures. It is not intended for use in the
spine. |
| Predicate Devices | Arrowhead Fixation Device (K100926)
NEWDEAL, S.A. K-wire (K022599) |
| Technological
Characteristics | The ARROW-LOK Digital Fusion System has similar technological
characteristics when compared to the predicate devices. In
addition, substantial equivalence was shown through Rotational
Forces Testing, Pull-out Testing and Four-Point Bend evaluations.
The evaluations confirmed that the ARROW-LOK Digital Fusion
System is at least equivalent to the predicate devices. |
| Substantial
Equivalence
Information | The ARROW-LOK Digital Fusion System is similar to legally
marketed devices including the Arrowhead Fixation Device,
newdeal K-wire, and the Arthrex K-wire. The ARROW-LOK Digital
Fusion System has similar indications for use and technological
characteristics as these predicate systems. Device and
performance evaluations confirmed that the ARROW-LOK Digital
Fusion System is substantially equivalent to the newdeal K-wire.
Therefore, the ARROW-LOK Digital Fusion System is determined to
be substantially equivalent to the predicate devices. |
1
K112675 (pg 212)
Exhibit 2
510(k) Summary
The 2.5mm Diameter ARROW-LOK Implant and the ARROW-LOK Hybrid Implant as Additions to the ARROW-LOK Digital Fusion System
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEC 1 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arrowhead Medical Device Technologies, LLC % Thomas J. Twardzik Vice President, Sales and Marketing 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K112675
Trade/Device Name: ARROW-LOK Digital Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: September 13, 2011 Received: September 14, 2011
Dear Mr. Twardzik:
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
3
Page - 2 - Mr. Thomas J. Twardzik
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 (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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erich Keith.
-for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit 1
Indications for Use Statement
510(k) Number: K112675
ARROW-LOK Digital Fusion System Device Name:
Indications for Use: The ARROW-LOK implant is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Prescription Use _ X _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Owens for MXM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112675
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