(121 days)
Not Found
No
The description focuses on the material properties (nitinol), mechanical function (active compression), and physical components of the device, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition, or to alleviate symptoms. This device is used for fixation of osteotomies and reconstruction of lesser toes following correctional procedures; it does not directly treat a disease or symptoms.
No
The device is described as a fixation system and implants for the correction of hammertoe, claw toe, and mallet toe, and for the fixation of osteotomies and bone reconstructions. Its purpose is therapeutic intervention (fixation and reconstruction), not to diagnose a condition.
No
The device description clearly states it is a physical implant made of nitinol, provided sterile and pre-packaged with a K-wire and Pusher instrument. This indicates it is a hardware medical device, not software-only.
Based on the provided information, 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 osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a "super-elastic, nitinol device" that is "implantable" and used for "active compression across the proximal interphalangeal joint." This further confirms it's a physical device implanted in the body.
- Anatomical Site: The anatomical sites mentioned are "lesser toes, proximal interphalangeal joint (PIPJ), metatarsophalangeal joint (MTP Joint)," which are all parts of the human anatomy where a surgical implant would be placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo for structural support and fixation.
N/A
Intended Use / 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 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-Wres 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
HTY
Device Description
The PRO-TOE® X-FLEX Hammer Fixation System is a super-elastic, nitinol device which provides active compression across the proximal interphalangeal joint (PIPJ). Unlike competitive nitinol devices on the market, the PRO-TOE® X-FLEX may be stored at room temperature, eliminating the need for freezer storage.
The device is offered in 3 sizes both available in 0° and 10° angulations. The implant is provided sterile and pre-packaged with a K-wire and Pusher instrument. The Pusher instrument is a polycarbonate molded component which is used to perform the final seating of the implant to a pre-determined depth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lesser toes, proximal interphalangeal joint (PIPJ), 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)
Performance testing including static and fatigue bend testing as well as localized corrosion resistance testing supports the substantial equivalence of the subject device to the predicate device and shows that no new worst-case devices are introduced in this system. The safety and effectiveness of the PRO-TOE® X-Flex Hammertoe Fixation System is adequately supported by testing, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101165, K120645, K070598, K132895, K140148, K124045
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The seal is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Wright Medical Technology, Incorporated Ms. Val Myles Regulatory Affairs Specialist I 1023 Cherry Road Memphis, Tennessee 38117
Re: K141714
Trade/Device Name: PRO-TOE® X-Flex Hammertoe Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: October 13, 2014 Received: October 14, 2014
Dear Ms. Myles:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Val Myles
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.
Lori A. Wiggins -S
for 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)
K141714
Device Name
PRO-TOE® X-Flex Hammertoe Fixation System
Indications for Use (Describe)
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 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-Wres 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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Image /page/3/Picture/0 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, to the left of the word "WRIGHT" in red. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in gray.
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
510(K) SUMMARY
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® X-Flex Hammertoe Fixation System.
| 1. Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|----------------------------------------------------------------------------------------------|
| Date: | October 17, 2014 |
| Contact Person: | Val Myles
Regulatory Affairs Specialist II
Office (901) 290-5162
Fax (901) 867-4190 |
| 2. Proprietary Name: | PRO-TOE® X-Flex Hammertoe Fixation System |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification Name and Reference: | 21 CFR 888.3040- Class II |
| Device Product Code, Device Panel: | HTY - Orthopedic |
3. Predicate Device:
- PRO-TOE™ VO Hammertoe Implant System (K101165 & K120645) ●
- . MMI Smart Toe® Hammertoe Implant (K070598)
- . WMT Implantable K-Wires (K132895 & K140148)
- . Solana Surgical FuseForce Implant System (K124045)
4. Device Description
The PRO-TOE® X-FLEX Hammer Fixation System is a super-elastic, nitinol device which provides active compression across the proximal interphalangeal joint (PIPJ). Unlike competitive nitinol devices on the market, the PRO-TOE® X-FLEX may be stored at room temperature, eliminating the need for freezer storage.
The device is offered in 3 sizes both available in 0° and 10° angulations. The implant is provided sterile and pre-packaged with a K-wire and Pusher instrument. The Pusher instrument is a polycarbonate molded component which is used to perform the final seating of the implant to a pre-determined depth.
4
5. Intended 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 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 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.
6. Technological Characteristics Comparison
The PRO-TOE® Hammertoe Fixation System was originally cleared in K101165 as a V-shaped, open-approach (VO) hammertoe fixation system consisting of implants fabricated from stainless steel (ASTM F138) and available in 2 sizes. Implants fabricated from titanium alloy (ASTM F136) as well as three additional size options were added to the system in K120645, for a total of 5 size options available in both stainless steel and titanium alloy. The PRO-TOE® X-Flex Hammertoe Fixation System and the legally marketed predicate PRO-TOE™ VO Hammertoe Implant System have similar indications and intended use. The PRO-TOE® X-Flex Hammertoe Fixation System and the legally marketed predicate MMI Smart Toe® Hammertoe Implant both use the same material, Nitinol. The modification to the system includes a change in geometry, a change in the material to Nitinol and a device specific instrument for performing the final seating of the implant by allowing the surgeon to maintain proper rotational alignment.
7. Substantial Equivalence- Non-Clinical Evidence
Performance testing including static and fatigue bend testing as well as localized corrosion resistance testing supports the substantial equivalence of the subject device to the predicate device and shows that no new worst-case devices are introduced in this system. The safety and effectiveness of the PRO-TOE® X-Flex Hammertoe Fixation System is adequately supported by testing, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
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.