(60 days)
Not Found
No
The 510(k) summary describes a mechanical fixation system for toe deformities and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is for fixation and reconstruction of the lesser toes, meaning it is a surgical implant used to correct anatomical deformities, rather than directly treating a disease or condition in a therapeutic manner.
No
The device is described as a fixation system for hammertoe, claw toe, and mallet toe corrections, involving implants and instruments for reconstruction. Its intended use is to physically fix and reconstruct toe structures, not to identify or diagnose medical conditions.
No
The device description explicitly states it is composed of implants and instruments made from stainless steel and titanium alloy, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of ostectomies and reconstruction of the lesser toes" and "fixation of bone reconstructions." This describes a surgical implant used within the body to support and stabilize bone, not a test performed outside the body on biological samples to diagnose a condition.
- Device Description: The description details implants made of stainless steel and titanium alloy, designed for surgical insertion. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information about a disease or condition
Therefore, the PRO-TOE® Hammertoe Fixation System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint),
The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The PRO-TOE® Hammertoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and are offered in multiple sizes. The implants are manufactured from stainless steel and titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes, MTP Joint
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)
Analysis related to pullout and static bend testing has shown that the subject implants do not present a new worst case.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated Mr. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
September 4, 2015
Re: K151838
Trade/Device Name: PRO-TOE Hammertoe Fixation System - C2 Implant Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 30, 2015 Received: July 6, 2015
Dear Mr. Mullins:
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
1
Page 2 - Mr. Michael Mullins
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151838
Device Name
PRO-TOE Hammertoe Fixation System - C2 Implant Line Addition
Indications for Use (Describe)
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of ostectomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint),
The Implantable K-Wires are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
Image /page/3/Picture/3 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PRO-TOE® Hammertoe Fixation System - C2 Line Addition.
| 1. | Submitted By: | Wright Medical Technology, Inc. |
|---|---|---|
| 1023 Cherry Road | ||
| Memphis, TN 38117 | ||
| Date: | June 30, 2015 | |
| Contact Person: | Michael Mullins | |
| Regulatory Affairs Specialist | ||
| Office: (901) 867-4142 | ||
| Fax: (901) 867-4190 | ||
| 2. | Proprietary Name: | PRO-TOE® Hammertoe Fixation System |
| Common Name: | Smooth or threaded metallic bone fixation | |
| fastener | ||
| Classification Name - Reference: | 21 CFR 888.3040- Class II | |
| Product Code - Device Panel: | HWC - Orthopedic | |
| 3. | Predicate Device: | K132895 - WMT Implantable K-Wire |
| K140148 - PRO-TOE® Hammertoe | ||
| Fixation System |
4. Device Description
The PRO-TOE® Hammertoe Fixation System is composed of implants and instruments intended for use in the fixation or reconstruction of the lesser toes. The implants within the PRO-TOE® Hammertoe System have proximal & distal fixation features and are offered in multiple sizes. The implants are manufactured from stainless steel and titanium alloy.
Exhibit 3 - 1
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5. Intended Use and Indications for Use
The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the exception of the PRO-TOE® X-Flex, can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
The Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
Technological Characteristics Comparison 6.
The PRO-TOE® Hammertoe Fixation System and the legally marketed predicate devices have similar indications and dimensions and have similar geometry and identical material. The purpose of this submission is to add additional sizes of the PRO-TOE® C2 implants to the PRO-TOE® Hammertoe System as well as update design of the VO Cannulated and C2 implants.
7. Substantial Equivalence- Non-Clinical Evidence
Analysis related to pullout and static bend testing has shown that the subject implants do not present a new worst case.
8. Substantial Equivalence- Clinical Evidence N/A
Substantial Equivalence- Conclusions 9.
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.