(139 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a PEEK implant for toe fixation, with no mention of AI or ML technology.
No.
The device is an implantable fixation system for surgical correction of toe deformities, not a therapeutic device meant to provide a therapy.
No
The device is an implant for fixation of osteotomies and reconstruction of lesser toes; it does not diagnose medical conditions.
No
The device description explicitly states it is a "threaded bone implant" made of PEEK, which is a physical hardware component. The performance studies also focus on mechanical properties of the implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The HammerTech® device is a physical implant (a PEEK threaded bone implant) intended for surgical fixation of bones in the toes. It is a medical device used in vivo (within the body) during a surgical procedure.
- Intended Use: The intended use is for the fixation of osteotomies and reconstruction of lesser toes, which is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The HammerTech® device 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 HammerTech® Fixation System implant is a polyetheretherketone (PEEK) threaded bone implant intended for fixation of the proximal interphalangeal (PIP) joint of the lesser toes. The PIP implant is comprised of two ends of a single, solid member. Each end slides into the prepared canal of the bone to be fused. The device is a straight cannulated design offered in four different sizes to address the wide variation of patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal interphalangeal (PIP) joint of the 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)
Non-clinical Test Summary: The following analyses were conducted: Static 4-point bending (ASTM F382), Dynamic 4-point bending (ASTM F382), Pull-out test (ASTM F543), Torsion test (ASTM F543), Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device. The results of these evaluations indicate that the HammerTech® Fixation System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
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.
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Image /page/0/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 image of three human profiles facing to the right, layered on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 11, 2016
Fusion Orthopedics, LLC % J.D. Webb Consultant The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K161449
Trade/Device Name: HammerTech® Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 14, 2016 Received: September 20, 2016
Dear J.D. Webb:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/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 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,
Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a clear, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are uniformly sized and spaced, contributing to the legibility of the name.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161449
Device Name
HammerTech® Fixation System
Indications for Use (Describe)
The HammerTech® device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.
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)
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510(k) Summary: HammerTech® Fixation System
| Date Prepared | October 3, 2016 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Contact | J.D. Webb |
| 1001 Oakwood Blvd | |
| Round Rock, TX 78681 | |
| 512-388-0199 Tele | |
| 512-692-3699 Fax | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | HammerTech® Fixation System |
| Common Name | Screw, Fixation, Bone |
| Classification Name | Smooth or threaded metallic bone fixation fastener. |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | HammerFiX, Extremity Medical, LLC (K133636) |
| Secondary Predicate | |
| Device | K-wire, Trilliant Surgical (K121008) |
| Device Description | The HammerTech® Fixation System implant is a polyetheretherketone |
| (PEEK) threaded bone implant intended for fixation of the proximal | |
| interphalangeal (PIP) joint of the lesser toes. The PIP implant is comprised of | |
| two ends of a single, solid member. Each end slides into the prepared canal | |
| of the bone to be fused. The device is a straight cannulated design offered in | |
| four different sizes to address the wide variation of patient anatomy. | |
| Materials | Polyetheretherketone (PEEK) (ASTM F2026) |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The HammerTech® Fixation System is substantially equivalent to the |
| predicate devices in terms of intended use, design, materials used, | |
| mechanical safety and performances. | |
| Indications for Use | The HammerTech® device is indicated for the fixation of osteotomies and |
| reconstruction of the lesser toes following correction procedures for | |
| hammertoe, claw toe and mallet toe. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ● Static 4-point bending (ASTM F382) | |
| ● Dynamic 4-point bending (ASTM F382) | |
| ● Pull-out test (ASTM F543) | |
| ● Torsion test (ASTM F543) | |
| ● Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) | |
| assay. The testing demonstrated that the subject device meets the | |
| recommended maximum endotoxin level of 20 EU per device. | |
| The results of these evaluations indicate that the HammerTech® Fixation | |
| System is equivalent to predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: | |
| Non-clinical and | |
| Clinical | Fusion Orthopedics, LLC considers the HammerTech® Fixation System to be |
| equivalent to the predicate devices listed above. This conclusion is based | |
| upon the devices' similarities in principles of operation, technology, materials | |
| and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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