(58 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implants and instruments, with no mention of AI or ML.
Yes.
The device is indicated for the fixation of osteotomies and reconstruction, which are therapeutic procedures.
No
The device, HammerTech Fixation System, is described as a system of implants used for the "fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe." This indicates a therapeutic or surgical function rather than a diagnostic one. The performance studies also focus on mechanical integrity and safety of the implant, not on diagnostic accuracy.
No
The device description explicitly states it consists of physical implants made of PEEK and titanium alloy, as well as surgical instruments made of stainless steel. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the HammerTech 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 directly in the body for structural support and repair.
- Device Description: The device consists of threaded bone implants made of PEEK and titanium, along with surgical instruments. These are physical devices used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The HammerTech device is a surgical implant used for mechanical fixation within the body.
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 consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interphalangeal 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 Annex 1) Dynamic 4-point bending (ASTM F382 Annex 2) Pull-out test (ASTM F543 Annex 3) Torsion test (ASTM F543 Annex 1) Insertion Torque (ASTM F543 Annex 2) 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 the 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.
0
November 23, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Fusion Orthopedics, LLC Eli Jacobson Authorized Contact Person 4135 S. Power Rd.. Suite 110 Mesa, Arizona 85212
Re: K182684
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 20, 2018 Received: September 26, 2018
Dear Eli Jacobson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182684
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)
✔ Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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In accordance with 21 CFR 807.92 of the Federal Code of Regulations
| Date Prepared | November 23, 2018 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Eli Jacobson |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: eli@fusionorthopedics.com | |
| Trade Name | HammerTech™ Fixation System |
| Common Name | Screw, Fixation, Bone |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | HammerTech™ Fixation System, Fusion Orthopedics (K161449) |
| Secondary | |
| Predicate Device | PHALINX Hammertoe System, Wright Medical Technology, Incorporated (K150252) K- |
| Wire, Trilliant Surgical (K121008) | |
| Device | |
| Description | The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM |
| F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for | |
| fixation of the interphalangeal joint of the lesser toes. The device is offered in three | |
| configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid | |
| titanium. Each configuration is offered in five different sizes to address to a variety of patient | |
| anatomy. The specialized instruments are made primarily of surgical grade stainless steel | |
| (ASTM F899). The implant and associated instrumentation is supplied sterile and non- | |
| sterile. | |
| 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. | |
| Materials | Ti-6Al-4V alloy (ASTM F136) |
| Stainless steel (ASTM F899) | |
| Polyetheretherketone (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. | |
| Comparison of | |
| Technological | |
| Characteristics | The design of the HammerTech Fixation System is similar in shape to the predicate devices |
| with a proximal threaded portion along with a distal barbed portion. HammerTech implants | |
| are fabricated from Polyetheretherketone (PEEK) or titanium alloy whereas the primary | |
| predicate is offered in only PEEK. The HammerTech Fixation is offered in smaller sizing | |
| than the primary predicate device. The HammerTech Fixation can be steam sterilized or | |
| sterile packaged whereas the primary predicate can only be provided sterile packed. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| Static 4-point bending (ASTM F382 Annex 1) Dynamic 4-point bending (ASTM F382 Annex 2) Pull-out test (ASTM F543 Annex 3) Torsion test (ASTM F543 Annex 1) Insertion Torque (ASTM F543 Annex 2) 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 the predicate devices. | |
| Clinical Test | |
| Summary | No clinical studies were performed |
| Conclusions: | 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, and indications for use. The non-clinical data supports | |
| that the HammerTech Fixation System should perform as intended in the specified use | |
| conditions and perform comparably to the predicate devices that are currently marketed for | |
| the same intended use. |
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