Linkt Compression Staple System

K250712 · Trax Surgical · JDR · May 14, 2025 · Orthopedic

Device Facts

Record IDK250712
Device NameLinkt Compression Staple System
ApplicantTrax Surgical
Product CodeJDR · Orthopedic
Decision DateMay 14, 2025
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3030
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Device Story

Linkt Compression Staple System consists of sterile Nitinol bone staples and single-use instruments (drill, drill guide, locating pins, insertion tool). Used by surgeons in clinical settings for fracture/osteotomy fixation and joint arthrodesis in hand and foot. Staples utilize shape-memory properties of Nitinol to provide compression across bone segments. Surgeon selects appropriate staple size (9mm x 9mm to 20mm x 20mm) based on patient anatomy; site prepared and staple deployed using provided instruments. Device provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is based on non-clinical bench testing including pull-out strength (ASTM F564), static and dynamic 4-point bend testing (ASTM F564), corrosion susceptibility (ASTM F2129), and RF-induced heating (ASTM F2182).

Technological Characteristics

Implants manufactured from Nitinol (ASTM F2063) with chemical etching and passivation. Features serrated gripping on staple legs. Provided sterile via gamma irradiation. Single-use instrument kit includes drill, drill guide, locating pins, and insertion tool. Mechanical fixation principle.

Indications for Use

Indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot in patients requiring bone stabilization.

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

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 14, 2025 Trax Surgical Stephen Deane Senior Vice President 75 Mill Street Stoughton, Massachusetts 02072 Re: K250712 Trade/Device Name: Linkt Compression 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 10, 2025 Received: March 10, 2025 Dear Stephen Deane: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250712 - Stephen Deane Page 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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). {2} K250712 - Stephen Deane Page 3 Sincerely, RYAN TROMBETTA -S For: 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250712 Device Name Linkt Compression Staple System Indications for Use (Describe) The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. 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) 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." Page 1 of 1 {4} K250712 Page 1 of 2 # 510(k) Summary In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Linkt Compression Staple System. **Submitted by:** Trax Surgical, Inc. 75 Mill Street Stoughton, MA 02072 **Date:** May 13, 2025 **Contact Person:** Stephen Deane Director, Quality Assurance 781.828.4400 **Proprietary Name:** Linkt Compression Staple System **Common Name:** Staple, Fixation, Bone **Regulation Number:** 21 CFR 888.3030 **Classification Name:** Single / multiple component metallic bone fixation appliances and accessories, **Device Product Code:** JDR **Device Class:** 2 **Review Panel:** Orthopedic **Primary Predicate Device:** Wright Medical FuseForce Flex Dynamic Compression System (K203832) **Additional Predicate Devices:** - Medline Unite Reflex Nitinol Staple System (K210482) - Medline Unite Reflex Nitinol Staple System (K231885) ## Device Description The Linkt Compression Staple System consists of individually packaged, sterile, bone staple implants and a separate single use, sterile instrument set. The implants are manufactured from a nickel titanium alloy (Nitinol) which meets the requirements of ASTM F2063. The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The staples are available in sizes ranging from 9mm x 9mm to 20mm x 20mm to allow the surgeon to select the appropriate device for the patient's anatomy. The single use instruments are intended to prepare the site and deploy the staple. The instrument kit includes a drill, drill guide, locating pins and an insertion tool. ## Indication for Use The Linkt™ Compression Staple System is intended to be used for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. {5} K250712 Page 2 of 2 # Technological Characteristics The Linkt™ Compression Staple System, compared to the predicates, has a similar design, indications for use, and performance characteristics. The system has the same principals of operation for bone fixation. Both subject and predicate are manufactured from the same Nitinol material (ASTM F 2063) share the same serrated gripping features on the staple legs. Both the subject device and primary predicate are provided sterile by gamma irradiation. # Performance Testing – Non-Clinical Performance testing has demonstrated substantial equivalence to the predicates in the following areas: - Pull out Strength Testing – ASTM F564 - Static 4 Point Bend Testing – ASTM F564 - Dynamic 4 Point Bend Testing – ASTM F564 - Corrosion Susceptibility Testing – ASTM F2129 - Radio - Frequency Induced Heating – ASTM F2182 # Performance Testing – Clinical This section does not apply. No clinical testing was performed # Performance Testing – Animal This section does not apply. No animal testing was performed # Conclusion In accordance with 21CFR807 and based on the information provided in this premarket notification, Trax Surgical concludes that the Linkt™ Compression Staple System is substantially equivalent to the predicate devices and does not raise any new questions related to safety or effectiveness.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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