Who is the manufacturer of JAWS Nitinol Staple System?

Paragon 28, Inc. filed the 510(k) submission for JAWS Nitinol Staple System (K230550).

What is the FDA product code for JAWS Nitinol Staple System?

JDR. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for JAWS Nitinol Staple System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like JAWS Nitinol Staple System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JAWS Nitinol Staple System

Q: What are the predicate devices for JAWS Nitinol Staple System?

JAWS® Nitinol Staple System (K223056).

K230550 · Paragon 28, Inc. · JDR · May 11, 2023 · Orthopedic

Device Facts

Record ID	K230550
Device Name	JAWS Nitinol Staple System
Applicant	Paragon 28, Inc.
Product Code	JDR · Orthopedic
Decision Date	May 11, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

JAWS® Nitinol Staple System consists of metallic bone staples of various sizes; used for osteotomy, arthrodesis, and fragment fixation in foot and lower extremity bones. Implants are manufactured from Nitinol; provided sterile. Device functions as mechanical fixation appliance to stabilize bone segments or fragments. Used by surgeons in clinical settings; provides compression or stabilization to facilitate bone healing. No software or electronic components.

Clinical Evidence

No clinical data. Evidence consists of engineering analysis, MR compatibility testing, and corrosion testing to demonstrate substantial equivalence.

Technological Characteristics

Metallic bone staples made of Nitinol. System includes various sizes for small bone applications. Provided sterile. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for patients requiring osteotomy, arthrodesis, or fixation of small bone fragments in the foot and lower extremity long bones (fibula, tibia).

Regulatory Classification

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.

Predicate Devices

JAWS® Nitinol Staple System (K223056)

Related Devices

K170923 — JAWS(TM) Nitinol Staple System · Paragon 28 · Jul 24, 2017
K203832 — FuseForce Flex Dynamic Compression System · Wright Medical · May 7, 2021
K160813 — EasyStep · Stryker GmbH · Jul 26, 2016
K070688 — NEXFIX COMPRESSION STAPLE · Nexa Orthopedics, Inc. · May 18, 2007
K192447 — Superelastic Staple · Neosteo · Feb 28, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. May 11, 2023 Paragon 28 Inc Haylie Hertz Senior Regulatory Affairs Specialist 14445 Grasslands Drive Englewood, Colorado 80112 Re: K230550 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: March 15, 2023 Received: March 15, 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 {1}------------------------------------------------ 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K230550 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) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"> ☑Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div style="display:flex; align-items:center;"> ☐Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ ## 510(K) SUMMARY | 510(k) Number: | K230550 | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer: | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 | | Contact: | Haylie Hertz Associate Regulatory Affairs Specialist Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 Phone: 303-720-0017 hhertz@paragon28.com | | Date Prepared: | May 11, 2023 | | Device Trade Name: | JAWS® Nitinol Staple System | | Device Class and Common Name: Classification: | Class II, staple, fixation, bone 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories | | Product Codes: | 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. | | Device Description: | The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile. | | Predicate Device: | JAWS® Nitinol Staple System (K223056) | | Substantial Equivalence: | The proposed JAWS® Nitinol Staple System is substantially equivalent to the predicate JAWS® Nitinol Staple System (K223056) with respect to indications, design, material and function. | | Performance Testing: | Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Testing on MR compatibility and corrosion was also conducted. The results of this analysis and testing demonstrated the modified designs are substantially equivalent to the predicate devices. | | Conclusions: | The JAWS® Nitinol Staple System subject to this submission possesses the same intended use and technological characteristics as the predicate device system components. All performance testing conducted for the JAWS® Nitinol Staple System met the predetermined acceptance criteria or were otherwise considered acceptable. As such, the JAWS® Nitinol Staple System components are substantially equivalent to the predicate devices for the intended use. | {4}------------------------------------------------