(139 days)
Not Found
No
The summary describes a mechanical bone staple system and its MR safety testing, with no mention of AI or ML.
Yes
This device is a therapeutic device because its intended use is for "osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments". This involves surgical procedures and the physical fixation of bone fragments, which are therapeutic actions to treat a medical condition.
No.
The device is described as an implantable staple system for surgical fixation of bones and joints, not for diagnosing conditions.
No
The device description explicitly states that the system includes "three styles of bone staples" and "instruments," which are physical hardware components. The performance studies also focus on the MR safety and compatibility of these physical implants.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The JAWS Nitinol Staple System is described as implants used for surgical fixation of bones and joints. This is a physical device implanted within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for osteotomy, arthrodesis, and fragment fixation of bones and joints, which are surgical procedures.
The information provided clearly indicates this is a surgical implant, not a diagnostic test performed in vitro.
N/A
Intended Use / Indications for Use
The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
Product codes
JDR
Device Description
The JAWS Nitinol Staple System includes three styles of bone staples having various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
bones and joints of the foot, long bones of the lower extremities such as the fibula and tibia.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards: Image Artifact per ASTM F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants Magnetically Induced Displacement Force per ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment Magnetically Induced Torque per ASTM F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment Radiofrequency (RF) Induced Heating per ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging Computational Modeling and Simulation of Radiofrequency Induced Heating in the Magnetic Resonance Environment.
Based on the results, the JAWS Nitinol Staples will be labeled as "MR Conditional" with MRI Safety Information in the instructions for use as described in ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 16, 2023
Paragon 28, Inc. Haylie Hertz Sr. Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K223056
Trade/Device Name: JAWS Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: January 20, 2023 Received: January 20, 2023
Dear Haylie Hertz:
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223056
Device Name JAWS Nitinol Staple System
Indications for Use (Describe)
The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
| 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) |
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510(K) SUMMARY
| 510(k) Number: | K223056 |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Hertz |
| Sr. Regulatory Affairs Specialist | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 303-720-0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | January 20, 2023 |
| Device Trade Name: | JAWS Nitinol Staple System |
| Device Class: | Class II |
| Predicate Device: | JAWS Nitinol Staple System (K170923) |
| Device Description: | The JAWS Nitinol Staple System includes three styles of bone |
| staples having various sizes to accommodate a variety of small bone | |
| applications. The implants and instruments are sold sterile. | |
| Classification and | |
| Product Code: | 21 CFR 888.3030; Staple, fixation, bone, JDR |
| Indications for Use: | The JAWS Nitinol Staple System implants are indicated for use in |
| osteotomy, arthrodesis and fragment fixation of bones and joint of | |
| the foot including fixation of small bone fragments (i.e., small | |
| fragments of bone which are not comminuted to the extent to | |
| preclude staple placement) located in the long bones of the lower | |
| extremities such as the fibula and tibia. | |
| Substantial | |
| Equivalence: | The intended use, principle of operation and fundamental scientific |
| technology of the modified device are identical to the predicate | |
| device. The MR safety and compatibility performance and labeling | |
| modifications were accomplished via testing in the MRI | |
| environment and updated labeling per the FDA Guidance “Testing | |
| and Labeling Medical Devices for Safety in the Magnetic | |
| Resonance (MR) Environment” issued May 20, 2021. The data | |
| Performance | |
| Testing: | MR Safety and Compatibility Testing has been completed and |
| presented in the submission as recommended in the FDA Guidance | |
| "Testing and Labeling Medical Devices for Safety in the Magnetic | |
| Resonance (MR) Environment" issued May 20, 2021, including | |
| FDA-recognized standards tests for the following potential hazards: | |
| Image Artifact per ASTM F2119 Test Method for | |
| Evaluation of MR Image Artifacts from Passive Implants Magnetically Induced Displacement Force per ASTM | |
| F2052 Test Method for Measurement of Magnetically | |
| Induced Displacement Force on Medical Devices in the | |
| Magnetic Resonance Environment Magnetically Induced Torque per ASTM F2213 Test | |
| Method for Measurement of Magnetically Induced Torque | |
| on Medical Devices in the Magnetic Resonance | |
| Environment Radiofrequency (RF) Induced Heating per ASTM F2182 | |
| Test Method for Measurement of Radio Frequency Induced | |
| Heating On or Near Passive Implants during Magnetic | |
| Resonance Imaging Computational Modeling and Simulation of | |
| Radiofrequency Induced Heating in the Magnetic | |
| Resonance Environment | |
| Based on the results, the JAWS Nitinol Staples will be labeled as | |
| "MR Conditional" with MRI Safety Information in the instructions | |
| for use as described in ASTM F2503 Standard Practice for | |
| Marking Medical Devices and Other Items for Safety in the | |
| Magnetic Resonance Environment. | |
| Conclusion: | The proposed device modifications do not raise new issues of safety |
| or effectiveness and has been fully evaluated. The subject devices | |
| are substantially equivalent to the legally marketed, predicate | |
| device. |
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demonstrate substantial equivalence and the subject modifications do not raise new issues of safety or effectiveness.