(66 days)
Not Found
No
The summary describes a mechanical orthopedic implant system and does not mention any AI or ML components or functionalities.
No
The device is described as a system for stabilization and inter-digital reconstruction of phalanges and fixation of small bones, which are structural and mechanical functions, not therapeutic.
No
The device is described as a system for stabilization and reconstruction of bones in the foot and fixation of small bones, not for diagnosing conditions.
No
The device description explicitly states that the system includes physical components such as intramedullary bone screws, a strut, and implantable K-wires. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the stabilization and reconstruction of bones in the foot. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implantable screws, a strut, and K-wires, which are physical implants used in 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.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device.
The implantable K-wires are indicated for use in the stabilization of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the joint. Additionally, the implantable K-wires are indicated as guide pins for instruments and implants in the HammerToe Compression System.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTY
Device Description
The HammerToe Compression System includes two intramedullary bone screws and a strut, which is provided pre-assembled with the proximal screw. Implantable K-wires are also provided in the system. The implants are provided in multiple diameters and lengths to accommodate variations in patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges of the foot, small bones
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)
All necessary testing has been performed on representative HammerToe Compression System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. The device performance was characterized via static and dynamic bending, pullout force, insertion/removal torque, and torque to failure testing. Clinical data are not needed to support the safety and effectiveness of the subject 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.
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January 25, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E., STE 280 Englewood, Colorado 80112
Re: K183228
Trade/Device Name: HammerToe Compression System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: November 14, 2018 Received: November 20, 2018
Dear Mr. Lintula:
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 mediation-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.
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2019.01.25, and the time is 11:03:16 -05'00'.
FOR 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
510(k) Number (if known) K183228
Device Name HammerToe Compression System
Indications for Use (Describe)
The HammerToe Compression System is indicated for use in the stabilization and inter-digital reconstruction of the phalanges of the foot, appropriate for the size of the device.
The implantable K-wires are indicated for use in the stabilization of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the joint. Additionally, the implantable K-wires are indicated as guide pins for instruments and implants in the HammerToe Compression System.
| 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)
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510(k) Summary
| Date: | November 14th, 2018 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Name: | HammerToe Compression System |
| Regulatory Class: | Class II |
| Regulation, | |
| Product Code, | |
| Classification, and | |
| Common Name: | 888.3040, HWC, Screw, Fixation, Bone |
| 888.3040, HTY, Pin, Fixation, Smooth | |
| Device | |
| Descriptions: | The HammerToe Compression System includes two |
| intramedullary bone screws and a strut, which is provided pre- | |
| assembled with the proximal screw. Implantable K-wires are | |
| also provided in the system. The implants are provided in | |
| multiple diameters and lengths to accommodate variations in | |
| patient anatomy. | |
| Indications for | |
| Use: | The HammerToe Compression System is indicated for use in the |
| stabilization and inter-digital reconstruction of the phalanges of | |
| the foot, appropriate for the size of the device. | |
| The implantable K-wires are indicated for use in the stabilization | |
| and fixation of small bones for use in bone reconstruction, | |
| osteotomy, arthrodesis, fracture repair and fixation, appropriate | |
| for the size of the joint. Additionally, the implantable K-wires | |
| are indicated as guide pins for insertion of instruments and | |
| implants in the HammerToe Compression System. | |
| Materials: | The HammerToe Compression System screws and strut are |
| made from Titanium Alloy. The K-Wires are manufactured from | |
| Stainless Steel. The instrumentation is manufactured from | |
| medical grades of stainless steel, polymer and titanium. | |
| Primary | |
| Predicate: | K171715, Paragon 28, Inc. HammerTube® System |
| Additional | |
| Predicate: | K130859, Arthrosurface, Inc. Hammertoe Correction System |
| Comparison to | |
| Predicate | |
| Indications: | The subject HammerToe Compression System and |
| HammerTube® System devices are intended to be used for | |
| stabilization of small bones. All indications for the subject | |
| device are within the indications of the predicate devices. | |
| Comparison to | |
| Predicate | Both the subject and the predicate components are designed to |
| achieve stabilization of small bones. In the case of the | |
| HammerToe Compression System, the devices thread into the | |
| Technological | |
| Characteristics: | medullary cavity of two adjacent small bones and engage with |
| each other to provide tension and compress the two bones | |
| together. In the case of the predicate device and the implantable | |
| K-wires, the device passes through the medullary cavities of two | |
| adjacent small bones to provide stabilization for compressing the | |
| two bones together. Differences between the HammerToe | |
| Compression implants (material, design, sizes) were shown not | |
| to raise new questions of safety and effectiveness. Therefore, the | |
| fundamental scientific technology of the HammerToe | |
| Compression System is similar to the predicate. | |
| Performance | |
| Data: | All necessary testing has been performed on representative |
| HammerToe Compression System components to assure | |
| substantial equivalence to its predicate and demonstrate the | |
| subject device performs as intended. All testing was performed | |
| on finished devices. | |
| The device performance was characterized via static and | |
| dynamic bending, pullout force, insertion/removal torque, and | |
| torque to failure testing. Clinical data are not needed to support | |
| the safety and effectiveness of the subject devices. | |
| Conclusion: | Performance testing demonstrates the substantial equivalence of |
| the HammerToe Compression System to the HammerTube® | |
| System. Therefore, the HammerToe Compression System is | |
| substantially equivalent to the HammerTube® System | |
| (K171715) with respect to their indications for use, technical | |
| characteristics, and function. |
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