(68 days)
No
The device description and performance studies focus on mechanical fixation and bench testing, with no mention of AI/ML, image processing, or data-driven analysis.
No
The device is described as a bone fixation device intended for fixation of osteotomies, which means it is used to hold bones together after a surgical cut. While it aids in the healing process, it doesn't directly deliver a therapeutic agent or exert a therapeutic effect itself; rather, it provides a structural support.
No
Explanation: The device is a bone fixation device, specifically for fixation of osteotomies of the calcaneus, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a bracket, lag screws, and instruments, which are physical hardware components.
No, 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 description clearly states that this device is a "bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery." It is surgically implanted to fix bone.
- Intended Use: The intended use is "for fixation of osteotomies of the calcaneus," which is a surgical procedure on bone.
This device is a surgical implant used directly on the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Product codes
HWC, HRS
Device Description
The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device consisting of a bracket and lag screws and a set of instruments used for implant site preparation and delivery. The bracket is offered in height sizes of 6mm to 13mm. The Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
calcaneus
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
Bench testing static and dynamic bending were performed and compared to the predicate device. No clinical testing was performed.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are depicted in a simple, line-art style. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2015
Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K143402
Trade/Device Name: Extremity Medical Calcaneal Osteotomy Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: November 25, 2014 Received: November 28, 2014
Dear Mr. Smekal:
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 - Mr. Brian Smekal
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K143402 (paqe 1/1)
Device Name
Extremity Medical Calcaneal Osteotomy Device
Indications for Use (Describe)
The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of osteotomies of the calcaneus.
Type of Use (Select one or both, as applicable)
2 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary of Safety and Effectiveness:
Extremity Medical Calcaneal Osteotomy Device
| Submitter: | Extremity Medical, LLC.
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
Director, Regulatory Affairs
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | November 25, 2014 |
| Trade Name | Extremity Medical Calcaneal Osteotomy Device |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | HWC (screw, fixation, bone), HRS (plate, fixation, bone) |
| Predicate Devices | K121349 - Extremity Medical Screw and Washer System (IO FiX)
K052614 - Arthrex Low Profile Plate and Screw System (Calcaneus
StepPlate)
K124022 - Speed Shift (Biomedical Enterprises) |
| Device Description | The Extremity Medical Calcaneal Osteotomy Device is a bone fixation device
consisting of a bracket and lag screws and a set of instruments used for implant
site preparation and delivery. The bracket is offered in height sizes of 6mm to
13mm. The Calcaneal Osteotomy Device is intended for fixation of
osteotomies of the calcaneus. |
| Indications for use | The Extremity Medical Calcaneal Osteotomy Device is intended for fixation of
osteotomies of the calcaneus. |
| Statement of
Technological
Comparison | The Extremity Medical Calcaneal Osteotomy Device and predicate devices are
equivalent in terms of indications for use, design, and material mechanical
properties. |
| Non-clinical Testing | Bench testing static and dynamic bending were performed and compared to the
predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The Extremity Medical Calcaneal Osteotomy Device is substantially
equivalent to its predicate device. This conclusion is based upon indications
for use, principles of operation, design, and mechanical test data. |