(53 days)
Not Found
No
The summary describes a mechanical implant for toe fixation and does not mention any software, algorithms, or data processing that would suggest AI/ML.
Yes.
The device is an implant system used for the fixation of osteotomies and reconstruction of lesser toes following corrective procedures, which directly addresses and treats a medical condition.
No
Explanation: The device is an implant system used for fixation and reconstruction of lesser toes after correction procedures, not for diagnosing medical conditions.
No
The device description clearly states it is an "Implant system" and discusses "implants" and "material," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of osteotomies and reconstruction of lesser toes following correction procedures. This is a surgical implant used in vivo (within the body) during a medical procedure.
- Device Description: The device is described as an implant system, which is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Product codes
HWC
Device Description
The subject implants are modified from the previously cleared Pro-Toe™ VO Hammertoe Implant System. They offer additional size ranges as well as additional material.
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)
Performance testing and engineering analysis supports the equivalence of the new sizes and shows that no new worst-case implants are introduced in this system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K12064S
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 4 2012
リッ
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™ VO Hammertoe Implant System - Line Addition.
Wright Medical Technology, Inc. (a)(1). Submitted By: 5677 Airline Road Arlington, TN 38002 February 15, 2012 Date: Ryan Bormann Contact Person: Regulatory Affairs Specialist (901) 867-4409 Pro-ToeTM VO Hammertoe Implant System -(a)(2). Proprietary Name: Line Addition Bone Plate System Common Name: Classification Name and Reference: 21 CFR 888.3040 - Class II Device Product Code, Device Panel: HWC: Orthopedic K101165 - Pro-Toe VO Hammertoe Implant (a)(3). Predicate Devices: System K022599 - Newdeal® K-Wire
(a)(4). Device Description
The subject implants are modified from the previously cleared Pro-Toe™ VO Hammertoe Implant System. They offer additional size ranges as well as additional material.
(a)(5). Intended Use
The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The indications statement is identical to that of the predicate Pro-Toe VO Hammertoe . Implant System's.
(a)(6). Technological Characteristics Comparison
While many of the technological characteristics are the same for the subject device system and the predicate, some design changes have been made. The subject implants are intended n to offer an extended size range in both length and diameter. In addition to extended sizes, the subject implant has also been developed to offer two different material options for each
1
K120645 2/2
size. The previously cleared stainless steel is intended to be offered in all sizes as well as Titanium alloy.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and engineering analysis supports the equivalence of the new sizes and shows that no new worst-case implants are introduced in this system.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. Performance testing and engineering analysis shows that no new worst-case design is introduced in this system. Additionally, ASTM standards for the new Titanium address the material change. From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. % Mr. Rvan Bormann 5677 Airline Road Arlington, TN 38002
APR 2 4 2012
Re: K120645
Trade/Device Name: Pro-Toe VO Hammertoe Implant System .- Line Addition Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 24, 2012 Received: March 2, 2012
Dear Mr. Bormann:
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 or any I 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 - Mr. Ryan Bormann
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/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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) Pro-Toe™ VO Hammertoe Implant System - Line Addition
INDICATIONS FOR USE STATEMENT 5.4.
510(k) Number (if known): Not yet assigned .-K120649
Device Name: Pro-Toe™ VO Hammertoe Implant System - Line Addition
Indications for Use:
The Pro-Toe™ VQ Hammertoe Implant System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
· Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic,
Division of Surgical, Davices Division of Surges
510(k) Number