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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the JAWS™ Nitinol Staple System. It focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or AI-driven performance.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission, as it's for a physical medical device (bone staple) and not a diagnostic algorithm or AI.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner with specific thresholds related to a performance study for the device's clinical efficacy or diagnostic accuracy. Instead, it refers to performance data from mechanical testing.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance
Static Bending Strength	Performed according to ASTM F564
Dynamic Bending Strength	Performed according to ASTM F564
Pullout Fixation Strength	Performed according to ASTM F564
Material Performance
Corrosion Resistance	Performed per ASTM F2129
Technological Characteristics	The same as one or more of the predicate devices: performance, basic design, material, and sizes (comparable dimensions).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to mechanical testing standards (ASTM F564, ASTM F2129) but does not detail the number of samples tested or the specifics of the test setup (e.g., country of origin, retrospective/prospective, which are not relevant for mechanical device testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The device is a bone staple. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically relevant for diagnostic devices or AI, not for the mechanical performance of a surgical implant. The "ground truth" for mechanical testing would be the physical properties measured in a lab according to established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are typically for subjective or clinical assessments, not for objective mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/not provided. This is a physical surgical implant, not a diagnostic or AI-assisted device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/not provided. This is a physical surgical implant, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is based on mechanical testing results obtained through standardized laboratory protocols (ASTM F564 for mechanical properties and ASTM F2129 for corrosion resistance). It's not based on expert consensus, pathology, or outcomes data in the clinical sense mentioned.

8. The sample size for the training set

This information is not applicable/not provided. This refers to a physical device, not an AI or machine learning model that would require a training set.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As above, there is no training set for a mechanical device.

Summary

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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

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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:

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K170923 Page 1/2

Date:	27 March 2017
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Facsimile: (888) 728-1220
Sponsor Contact:	Frank S. Bono, Chief Technology Officer
510(k) Contact:	Karen E. Warden, PhDBackRoads Consulting, Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Names:	JAWS™ Nitinol Staple System
Common Name:	Bone staple
Regulatory Class:	Class II
Classification Name /Regulation / ProductCode:	Staple, fixation, bone / 888.3030 / JDR
Device Description:	The JAWS™ Nitinol Staple System includes three styles of bone stapleshaving various sizes to accommodate a variety of small boneapplications. The implants and instruments are sold sterile.
Indications for Use:	The JAWS™ Nitinol Staple System implants are indicated for use inosteotomy, arthrodesis and fragment fixation of bones and joint of thefoot including fixation of small bone fragments (i.e. small fragments ofbone which are not comminuted to the extent to preclude stapleplacement) located in the long bones of the lower extremities such as thefibula 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 wasperformed according to ASTM F564. In addition, corrosion testing perASTM F2129 was performed.
TechnologicalCharacteristics:	The JAWS™ Nitinol Staple System possesses the same technologicalcharacteristics as one or more of the predicate devices. These include:• performance,• basic design,• material and• sizes (dimensions are comparable to those offered by thepredicate systems).Therefore the fundamental scientific technology of the JAWS™ NitinolStaple 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.

Regulation Number and Section

§ 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.