(117 days)
Not Found
No
The summary describes a mechanical bone staple system and its performance testing, with no mention of AI or ML technology.
No
The device is a bone staple system used for fixation in osteotomy, arthrodesis, and fragment fixation of bones and joints, which is a surgical intervention rather than a therapeutic treatment in itself.
No
The device is a system of implants (staples) used for fixation of bones and joints, not for diagnosing conditions.
No
The device description explicitly states it includes "three styles of bone staples" and "instruments," which are physical 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 states that the device is for "osteotomy, arthrodesis and fragment fixation of bones and joint of the foot including fixation of small bone fragments...". This describes a surgical implant used directly on the patient's body for structural support and fixation.
- Device Description: The device is described as "bone staples" and "implants". These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / 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.
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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and joint 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and dynamic bending, and pullout fixation strength testing was performed according to ASTM F564. In addition, corrosion testing per ASTM F2129 was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001354, K061798, K002695, K123363
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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Paragon 28 % Karen Warden Representative/Consultant BackRoads Consulting. Inc PO Box 566 Chesterland, Ohio 44026-0566
July 24, 2017
Re: K170923
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: June 8, 2017 Received: June 9, 2017
Dear Karen Warden:
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 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,
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 on last page.
510(k) Number (if known)
K170923
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 bones and joint of the foot including fixation of small bone 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)
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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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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K170923 Page 1/2
| Date: | 27 March 2017 |
|---|---|
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Facsimile: (888) 728-1220 | |
| Sponsor Contact: | Frank S. Bono, Chief Technology Officer |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting, Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Names: | JAWS™ Nitinol Staple System |
| Common Name: | Bone staple |
| Regulatory Class: | Class II |
| Classification Name / | |
| Regulation / Product | |
| Code: | Staple, fixation, bone / 888.3030 / 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. | |
| 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. | |
| Materials: | The JAWS™ Nitinol Staple System implants are made from Nitinol |
| (ASTM F2063). | |
| Primary Predicate: | OSStaple (BioMedical Enterprises, Inc. - K001354) |
| Additional Predicates: | Biopro Memory Staple (Biopro, Inc. - K061798), |
| Memodyn Staple (Telos Medical Equipment – K002695), | |
| Super Staple™ Classic (Metric Medical Devices, Inc. – K123363) | |
| Performance Data: | Static and dynamic bending, and pullout fixation strength testing was |
| performed according to ASTM F564. In addition, corrosion testing per | |
| ASTM F2129 was performed. | |
| Technological | |
| Characteristics: | The JAWS™ Nitinol Staple System possesses the same technological |
| characteristics as one or more of the predicate devices. These include: | |
| • performance, | |
| • basic design, | |
| • material and | |
| • sizes (dimensions are comparable to those offered by the | |
| predicate systems). | |
| Therefore the fundamental scientific technology of the JAWS™ Nitinol | |
| Staple System is similar to previously cleared devices. |
510(k) Summary
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The JAWS™ Nitinol Staple System possesses indications for use and
technological characteristics the same as the predicate devices. Conclusion: Therefore the JAWS™ Nitinol Staple System is substantially equivalent to the predicates.