(101 days)
Not Found
No
The device description focuses on the mechanical components and materials of the implant and instruments, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is used for the "fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe," which are therapeutic interventions.
No
The ExtremiFuse System is a surgical implant designed for the fixation of osteotomies and reconstruction of lesser toes. It is used in treatment and repair, not for diagnosing conditions.
No
The device description clearly outlines physical implants made of titanium alloy and surgical instruments made of stainless steel, aluminum, and plastic. There is no mention of software as a component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The OSTEOMED ExtremiFuse System is a surgical implant and associated instruments used for the physical fixation and fusion of bones in the toes. It is a physical device used in the body, not a test performed on samples from the body.
- Intended Use: The intended use is for the surgical fixation and reconstruction of bones, not for diagnostic testing.
Therefore, the OSTEOMED ExtremiFuse System falls under the category of a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OSTEOMED ExtremiFuse 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 (comma separated list FDA assigned to the subject device)
HWC
Device Description
The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.
The system instruments include wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.
The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges, 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)
The ExtremiFuse implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use.
The ExtremiFuse System was evaluated to be safe and effective in performing as well or better when compared to the predicate devices for the intended use.
Substantial equivalence was shown through the pullout test, torque test, and bending test 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
Image /page/0/Picture/0 description: The image shows the logo for Osteomed. The logo is in black and white and features the word "Osteomed" in a bold, sans-serif font. The word is enclosed in an oval shape. The oval shape is slightly distorted, with the top and bottom edges being slightly curved.
Submitter Information:
510(k) Summary
MAY 3 1 2013
OsteoMed 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Piedad Peña
Date Prepared:
February 18, 2013
Device Information:
Proprietary/Trade Name: Common Name:
OSTEOMED ExtremiFuse™ System Hammer Toe Implant
Classification Name:
- · Regulation Number: 21 CFR 888.3040
- Regulation Name: Smooth or threaded metallic bone . fixation fastener.
- Product Code: . HWC o
Device Class: II
Predicate Devices:
Pro-Toe VO HammerToe Implant System, K101165
Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)
Device Class: II
OsteoMed Foot Plate and Screw Rigid Fixation System, K091614 Classification Name: Single/multiple component metallic bone fixation appliances and accessories (21CFR 888.3030, Product Code HRS) Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)
Device Class: Il
OsteoMed Extended 2.0/2.4 Cannulated Screw System, K062863 Classification Name: Smooth or threaded metallic bone fixation fastener (21CFR 888.3040, Product Code HWC)
Device Class: II
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (972) 677-4601 Customer Service: (800) 456-7779
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Device Description:
The OSTEOMED ExtremiFuse System is indicated for small bone reconstruction limited to interdigital repair and fusion of the phalanges. The ExtremiFuse implant is a one piece implant with a threaded portion and a barbed portion that holds the resected faces of the two phalanges together. The implant is offered in 3 diameter sizes of 2.4mm, 3.0mm and 4.0mm. For each size, the implant is available in angle configurations of 0° and 10°.
The system instruments include wires, broaches, cannulated drills, and implant drivers to facilitate the placement of the implants.
The ExtremiFuse implants are made from implant grade titanium alloy (Ti6Al4V) per ASTM F136. The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.
Intended Use:
The OSTEOMED ExtremiFuse System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Technological Characteristics:
The OstEOMED ExtremiFuse implant is recommended for arthrodesis of the proximal interphalangeal (PIP) joints of the Lesser Digits. The threaded portion of the implant is screwed into the proximal phalange to engage the bone and create a solid base. Following pilot drilling, the barbed side is pressed into the remaining distal phalange to create bone to bone contact during fixation.
ExtremiFuse devices are manufactured from titanium alloy (Ti6AI4V), the OSTEOMED Cannulated Screw System predicate. This material is biocompatible.
Performance / Clinical Data:
The OSTEOMED ExtremiFuse System was compared to the Pro-Toe VO Hammertoe Implant, the OSTEOMED Cannulated Screw System, and the OSTEOMED Foot Plating System, K-Wires. The ExtremiFuse implants underwent verification evaluation to ensure that the design features met the required mechanical strength criteria for their intended use. The intended use of the OsTEOMED ExtremiFuse implant is the same as the Pro-Toe VO Hammertoe Implant System predicate device (K101165).
Clinical Testing is not required to support substantial equivalence:
In conclusion, the device was evaluated to be safe and effective in performing as well or better when compared to the predicate devices for the intended use.
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Substantial Equivalence:
A design and dimensional comparison was performed to establish substantial equivalence to the legally marketed predicate devices listed in this summary. The basis of substantial equivalence for this device is based on similarities in intended use, function, performance, design, technology and operational principles to the Pro-Toe VO Hammertoe Implant System (K101165), and similarities in material, function, and performance to the OsteoMed Cannulated Screw System (K062863) and OsteoMed Foot Plating System, K-Wires (K091614).
Substantial equivalence was shown through the pullout test, torque test, and bending test to the predicate devices. The indications, design, technology and operational principles are similar between the subject and predicate, Pro-Toe VO Hammertoe Implant, and therefore OsteoMed believes that the OSTEOMED ExtremiFuse System does not raise any new safety or effectiveness issues.
EFS Page 74 of 302
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 31, 2013
OsteoMed % Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K130412
Trade/Device Name: Osteomed ExtremiFuse System Regulation Number: 21 CFR 888.3040 Regulatory Class: Class II Regulation Name: Smooth or threaded metallic bone fixation fastener Product Code: HWC Dated: March 18, 2013 Received: March 19, 2013
Dear Ms. Peña:
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
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Page 2 - Ms. Piedad Peña
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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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 Newlelkerson -S
Mark N. Melkerson Director Division-of-Orthopedic-Devices-Office of Device Evaluation™ Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130412 ......
Device Name: OsteoMed ExtremiFuse System
Indications for Use:
The OSTEOMED ExtremiFuse 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabethi @Frank -S
Division of Orthopedic Devices