(58 days)
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Nitinol Staples are indicated for:
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.
The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.
This document is a 510(k) Summary for the Arthrex DynaNite Nitinol Staples, which is a medical device. It describes the device's indications for use and states that the submission is to expand these indications. The document mainly focuses on proving substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria for a new device.
Therefore, the information provided does not directly describe a study that sets acceptance criteria for device performance in the sense of accuracy or efficacy (as would be typical for an AI/CADe device). Instead, it describes performance testing conducted to demonstrate safety and substantial equivalence for an implantable medical device.
Based on the provided text, here’s an extraction of the requested information, adapted for a medical device rather than an AI/CADe system:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity thresholds). Instead, it describes types of performance tests and implies the acceptance criterion is "perform substantially equivalent" or "meets specifications" for safety parameters.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cyclic/Fatigue Testing (with Arthrex Cerclage Sutures) | Perform substantially equivalent to the Arthrex Cerclage Suture construct for sternal closure. | "Cyclic/Fatigue construct testing was conducted to demonstrate that when used with the Arthrex Cerclage Sutures, the Arthrex DynaNite Nitinol Staples perform substantially equivalent to the Arthrex Cerclage Suture construct for sternal closure." |
| MRI Compatibility (Force, Torque, Image Artifact) | Meets safety standards as per FDA guidance and ASTM standards for MR Environment. | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance [specific guidance documents listed]... and ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213." (Implied: met the standards.) |
| Bacterial Endotoxin | Meets pyrogen limit specifications per EP 2.6.14/USP <85>. | "Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes or data provenance for the performance tests conducted. These tests are typically biomechanical or material tests performed in a lab setting, not clinical studies with human data.
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 is not applicable as the studies described are laboratory performance tests for a physical implant, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the types of engineering and material performance tests described.
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 is not applicable, as the device is a physical bone fixation staple, not an AI/CADe system for diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable, as the device is a physical bone fixation staple, not an algorithm. Performance tests are inherently "standalone" in this context, evaluating the physical properties of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described:
- Cyclic/Fatigue Testing: The "ground truth" or reference is the performance of the predicate device/construct (Arthrex Cerclage Suture construct).
- MRI Compatibility: The "ground truth" is established by relevant national and international standards (FDA guidance, ASTM standards).
- Bacterial Endotoxin: The "ground truth" is established by pharmacopeial standards (EP 2.6.14/USP <85> pyrogen limit specifications).
8. The sample size for the training set
This is not applicable, as the device is a physical bone fixation staple and does not involve AI model training.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned above.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 31, 2025
Arthrex Inc. Rebecca R. Homan Manager, Regulatory Affairs - Product Development 1370 Creekside Blvd. Naples, Florida 34108
Re: K243742
Trade/Device Name: Arthrex DynaNite Nitinol Staples Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR, JDQ Dated: December 3, 2024 Received: December 4, 2024
Dear Rebecca R. Homan:
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.
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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).
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 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-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 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory
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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).
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Limin Sun -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
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
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Indications for Use
Submission Number (if known)
Device Name
Arthrex DynaNite Nitinol Staples
Indications for Use (Describe)
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as:
LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform ioint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Nitinol Staples are indicated for:
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy.
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
· When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for Arthrex. The logo is in black and white and features the company name in a bold, sans-serif font. To the right of the name is an image of a surgical instrument, possibly scissors or forceps, which is likely related to the company's medical focus.
510(k) Summary
| Date Prepared | January 31, 2025 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Rebecca R. HomanManager, Regulatory Affairs239-598-4302 ex. 73429Rebecca.Homan@Arthrex.com |
| Trade Name | Arthrex DynaNite Nitinol Staples |
| Common Name | Staple, Fixation, Bone |
| Product Code | JDR, JDQ |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessories |
| Regulatory Class | II |
| Primary PredicateDevice | K203180 - Arthrex DynaNite Nitinol Staple |
| Additional PredicateDevices | K172052 - Arthrex DynaNite Nitinol StapleK232755 - Arthrex FiberTape and TigerTape Cerclage SuturesK230976 - Arthrex Radiopaque FiberTape Cerclage Sutures |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted toexpand the indications for use for the Arthrex DynaNiteNitinol Staples. |
| Device Description | The Arthrex DynaNite Nitinol Staples are Nickel Titanium(Nitinol) bone fixation devices intended to be permanentlyimplanted. The implant is formed with two legs connected bya bridge and is offered in multiple combinations of bridgewidths, leg lengths, and cross sections to accommodatevarious anatomy. |
| Indications for Use | The Arthrex DynaNite Nitinol Staple is intended to be used forfixation such as: LisFranc arthrodesis, mono or bi-corticalosteotomies in the forefoot, first metatarsophalangealarthrodesis, Akin osteotomy, midfoot and hindfootarthrodeses or osteotomies, fixation of osteotomies for halluxvalgus treatment (Scarf and Chevron), and arthrodesis of themetatarsocuneiform joint to reposition and stabilizemetatarsus primus varus |
| The Arthrex DynaNite Nitinol Staples are indicated for:• Fracture and osteotomy fixation and joint arthrodesis of thehand and foot.• Fixation of proximal tibial metaphysis osteotomy.• Hand and foot bone fragment and osteotomy fixation andjoint arthrodesis.• Fixation of small bone fragments (i.e. small fragments ofbone which are not comminuted to the extent to precludestaple placement). These fragments may be located in longbones such as femur, fibula and tibia in the lower extremities;the humerus, ulna or radius in the upper extremities; theclavicle and ribs; and in flat bone such as the pelvis, scapulaand sternum.• When used with Arthrex FiberTape Cerclage System, theArthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) isintended for sternotomy indications including the "rewiring"of osteotomized sternums. | |
| Performance Data | Cyclic/Fatigue construct testing was conducted todemonstrate that when used with the Arthrex CerclageSutures, the Arthrex DynaNite Nitinol Staples performsubstantially equivalent to the Arthrex Cerclage Sutureconstruct for sternal closure.MRI force, torque, and image artifact testing were conductedin accordance with FDA guidance Testing and Labeling MedicalDevices for Safety in the Magnetic Resonance (MR)Environment, ASTM F2052 Standard Test Method forMeasurement of Magnetically Induced Displacement Force onMedical Devices in the Magnetic Resonance Environment,ASTM F2119 Standard Test Method for Evaluation of MRImage Artifacts from Passive Implants, ASTM F2182 StandardTest Method for Measurement of Measurement of RadioFrequency Induced Heating Near Passive Implants DuringMagnetic Resonance Imaging and ASTM F2213 Standard TestMethod for Measurement of Magnetically Induced Torque onMedical Devices in the Magnetic Resonance Environment. |
| Bacterial endotoxin per EP 2.6.14/USP <85> was conducted todemonstrate that the device meets pyrogen limitspecifications. | |
| TechnologicalComparison | The proposed devices are identical in technologicalcharacteristics (device design, sterilization, packaging, andbiocompatibility). The proposed modification consists of theadditional indication of sternotomy indications. |
| Conclusion | The Arthrex DynaNite Nitinol Staples are substantiallyequivalent to the predicate device in which the basic designfeatures and intended use are the same. Any differencesbetween the proposed device and the predicate areconsidered minor and do not raise any new or differentquestions concerning safety and effectiveness. Based on theindications for use, technological characteristics, and the datasubmitted, Arthrex Inc. has determined that the proposeddevice is substantially equivalent to the currently marketedpredicate device. |
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Image /page/5/Picture/1 description: The image shows the word "Arthrex" in a sans-serif font. The "x" in "Arthrex" is stylized to include an image of a surgical instrument. To the right of the "x" is the registered trademark symbol.
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Image /page/6/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical instrument, possibly scissors or forceps. The logo is simple and professional, and it is likely used to represent the company's brand.
§ 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.