(88 days)
No
The summary describes a mechanical implant for toe fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an implant system used for fixation and reconstruction of lesser toes following corrective procedures, which aims to treat a medical condition (hammertoe, claw toe, mallet toe).
No
This device is an implant system used for fixation and reconstruction of lesser toes following correction procedures. It does not perform any diagnostic functions.
No
The device description explicitly states the device is an "Implant System" manufactured from "stainless steel," indicating it is a physical hardware 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 the lesser toes following surgical procedures. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is a physical implant made of stainless steel.
- Lack of IVD Characteristics: IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The description of the PRO-TOE™ VO Hammertoe Implant System does not involve any such testing or analysis of biological samples.
Therefore, the PRO-TOE™ VO Hammertoe Implant System is a surgical implant, not an In Vitro Diagnostic device.
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 PRO-TOE™ VO Hammertoe Implant System will be offered in two sizes and two different blade angles. The implants will be manufactured from stainless steel.
The design features of the PRO-TOE™ VO Hammertoe Implant System are substantially equivalent to the design features of other devices previously cleared for market.
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
Prescription Use
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
Substantial equivalence was shown through cantilever bend testing. The results of the test show that the subject PRO-TOE™ VO Hammertoe implants can be expected to perform at least as well as the legally marketed predicate newdeal® K-wires.
Key Metrics
Not Found
Predicate Device(s)
newdeal® K-Wire (K022599)
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
K101165 '1/2
JUL 2 3 2010
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-TOETM VO Hammertoe Implant System.
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------|
| Date: | April 23, 2010 |
| Contact Person: | Kelsey Lee |
| | Regulatory Affairs Specialist I |
| | (901) 290-5909 |
| A.2. Proprietary Name: | PRO-TOE™ VO Hammertoe Implant System |
| Common Name: | Intramedullary Bone Fastener |
| Device Classification Regulation: | 21 CFR 888.3040--Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation, Bone |
| | 87 Orthopedics |
| A.3. Predicate Device: | newdeal® K-Wire (K022599) |
A.4. Device Description
The PRO-TOE™ VO Hammertoe Implant System will be offered in two sizes and two different blade angles. The implants will be manufactured from stainless steel.
The design features of the PRO-TOE™ VO Hammertoe Implant System are substantially equivalent to the design features of other devices previously cleared for market.
A.S. Intended Use
The PRO-TOE™ VO Hamemrtoe 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 are similar to the legally marketed predicate device. Wright Medical Technology, Inc. has chosen to include specific types of reconstruction to focus on the market in which the subject device is being promoted.
1
K101152 2/2
A.6. Technological Characteristics Comparison
The subject PRO-TOE™ VO Hammertoe Implants and the legally marketed predicate newdeal® K-wires have similar indications and are both manufactured from stainless steel.
The PRO-TOE™ VO Hammertoe Implants differ from the legally marketed predicate newdeal® K-wires in size offerings and fixation design characteristics.
B.1. Substantial Equivalence – Non-Clinical Evidence
Substantial equivalence was shown through cantilever bend testing. The results of the test show that the subject PRO-TOE™ VO Hammertoe implants can be expected to perform at least as well as the legally marketed predicate newdeal® K-wires.
The safety and effectiveness of the PRO-TOE™ VO Hammertoe Implant System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence – Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through a cantilever bend test. The materials and indications are similar and the subject and predicated differ in fixation design characteristics and diameters, but no new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected.
to perform at least as well of the Premarket Notification, the subject devices can to perform at least as well as the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Wright Medical Technologies, Inc. % Ms. Kelsey Lee 5677 Airline Road Arlington, TN 38002
JUL 2 3 2010
Re: K101165
Trade/Device Name: PRO-TOE VO Hammertoe Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 2, 2010 Received: July 6, 2010
Dear Ms. Lee:
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 In microco in microante devices that have been reclassified in accordance with the provisions of the Federal Food, Drig, 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, ilsting 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 misleding.
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 Rregister.
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 st 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 100-1050.
3
Page 2 - Ms. Kelsey Lee
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/CDRH0ffices/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 A. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K IOI I (ø
Device Name: PRO-TOE™ VO Hammertoe Implant System
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.
Prescription Use × (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)
1 of 1
Qutta for nxm
(Division Signoff)
(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101165