(168 days)
The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. The implant is fully cannulated with threads on the distal side and two barbs on the proximal side. The implant is offered in multiple combinations of diameter and length to accommodate various anatomies. The dynaMX™ Intramedullary Implant is made of biocompatible Nitinol. The barbs of the implant are designed to exhibit superelastic properties at room and body temperature. As manufactured, one end of the implant has a screw thread, and the other end a pair of barbs. The screw thread is inserted into a drilled hole in the middle phalange. The barbed end is implanted into a broached canal in the proximal phalange. While inserting the barbed end of the implant, the barbs deflect inward to allow the implant to pass through the broached canal. Once inside the canal, the barbs superelastically return to their flared outward configuration to securely hold the implant in the bone. The dynaMX™ Intramedullary Implant is sold as part of a single use disposable kit. The kit includes an implant, pre-loaded onto a delivery device, a drill bit, a broach and a quide wire.
The provided document is a 510(k) premarket notification for a medical device called the "dynaMX™ Intramedullary Implant." This type of document is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not contain detailed acceptance criteria and study results in the same way a clinical trial report would.
However, based on the information provided, I can infer what constitutes the "acceptance criteria" through the bench and cadaver testing listed and how the device aims to meet these through comparison with predicate devices.
Here's an analysis based on your request, structured as much as possible with the available information:
Key Takeaway: The document outlines a substantial equivalence claim based on laboratory studies (bench and cadaver tests) rather than human clinical trials involving complex statistical criteria for AI performance. Therefore, many of your specific questions related to AI-specific metrics, human reader studies, and large-scale data provenance are not applicable to this type of device and submission.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for the dynaMX™ Intramedullary Implant are demonstrated through a series of laboratory studies (bench tests and cadaver tests) designed to verify the suitability of the device for its intended use, establish substantial equivalence with predicate devices, and confirm reproducibility of packaging. The successful completion of these tests, showing comparable performance to predicate devices, serves as the primary evidence for meeting acceptance criteria for this Class II medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Measure/Test | Reported Device Performance (as stated in the document) |
|---|---|---|
| Mechanical Performance / Structural Integrity | Elastic Static Bending Testing | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) |
| Bending Fatigue Testing | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) | |
| Implant Pull-Out Force | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. The device's design, with a screw thread on one end and superelastic barbs on the other, is described to "securely hold the implant in the bone." | |
| Rotational Stability | Conducted to verify suitability and establish Substantial Equivalence with predicate devices. (Specific quantitative results or pass/fail thresholds are not detailed in this summary.) | |
| Biocompatibility | Corrosion Testing | Conducted. (Specific results not detailed, but generally, acceptance would be low/negligible corrosion appropriate for implants.) |
| Transformation Temperature Determination (for Nitinol) | Conducted. (Specific results not detailed, but acceptance would be within a range demonstrating appropriate superelastic properties at body temperature.) | |
| Pyrogenicity | Endotoxin testing conducted to confirm the implant is non-pyrogenic. (Implies successful completion.) | |
| Packaging & Sterilization | Package Seal Strength Verification | Confirmed reproducibility of the packaging. (Implies successful completion.) |
| Shelf Life / Stability | A shelf-life/stability protocol has been designed to support expiry dating of up to 36 months, with an initial proposed shelf-life of 6 months following completion of the initial study. | |
| Material Equivalence | Material Composition | Fabricated from Nitinol per ASTM F2063-12. This is explicitly compared to predicate devices, some also using Nitinol,others using stainless steel or titanium. |
| Functional Equivalence | Stabilize and aid in fixation of phalangeal fractures, fusions, and osteotomies | Demonstrated through laboratory studies and substantial equivalence comparison to predicate devices with similar indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size for the bench and cadaver tests. It generally states a "series of laboratory studies." For cadaver tests, typically a limited number of cadaveric specimens would be used.
The data provenance is laboratory-based (bench tests) and cadaveric. There is no information regarding country of origin, but it is assumed the tests were conducted within the facilities of Arthrex, Inc. (or MX Orthopedics, Corp.) or their designated testing laboratories. These are effectively retrospective in the sense that they are conducted on inert materials or cadaveric tissue in a controlled lab setting, not in live patients.
3. Number of Experts Used to Establish the Ground Truth For The Test Set and Qualifications of Those Experts
This information is not applicable as the device is an implantable mechanical device, not an AI or diagnostic device that relies on expert ground truth for interpretation of output. The "ground truth" for this device's performance would be the physical properties and mechanical behavior observed in the specified laboratory tests.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication typically refers to expert consensus in interpreting diagnostic results or clinical outcomes. The performance of this device is assessed directly through engineering measurements and established material science principles in laboratory settings.
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. This device is a surgical implant, not a diagnostic or AI-powered system, and therefore, human reader studies with AI assistance are irrelevant to its evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical implant; there is no algorithm involved in its direct function for standalone performance evaluation in this context.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily engineering specifications, material science properties, and established biomechanical performance standards for bone fixation devices. This is demonstrated through direct physical measurements and observations during bench and cadaver tests. The comparison to predicate devices also establishes a benchmark for "ground truth" in terms of acceptable clinical performance and safety.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" for this type of device.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Inc. %Howard Schraver Mx Orthopedics. Corp. 1050 Waltham Street. Suite 510 Lexington, Massachusetts 02421 July 20, 2017
Re: K170326
Trade/Device Name: dynaMXTM Intramedullary Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: June 20, 2017 Received: June 21, 2017
Dear Mr. Schrayer:
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 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
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related 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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INDICATIONS FOR USE
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 below.
510(k) Number (if known)
Device Name
dynaMXTM Intramedullary Fixation Device
Indications for Use (Describe)
The dynaMX™ Intramedulary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
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)
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FORM FDA 3881 (8/14)
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
| Name: | Arthrex, Inc.Originally, MÖ Orthopedics, Corp. |
|---|---|
| Contact: | Howard SchrayerRegulatory Affairs Consultant |
| Address: | 1050 Waltham St. Suite 510Lexington, MA 02421 |
| Telephone: | (617) 270 - 6608 |
- April 24, 2017 Date Prepared
General Device Information
- Product Name: dynaMŸ™ Intramedullary Implant
- Classification: "Bone Fixation Fastners" Product code: HTY - Class II 21 CFR 888.3040
Predicate Device
| DePuy (Primary Predicate) | Sterile Kirschner Wires and Steinmann Pins |
|---|---|
| [510(k) Number K960385] | |
| OrthoHelix | Intraosseous Fixation System |
| [510(k) Number K120165] | |
| Wright Medical | PRO-TOE® Hammertoe Fixation System |
| [510(k) Number K140148] | |
| BioMedical Enterprises | HammerLock® 2 |
| [510(k) Number K133520] | |
| Memometal Technologies | Smart Toe and X-Fuse |
| [510(k) Number K070598] |
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Description
The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges,
- . The implant is fully cannulated with threads on the distal side and two barbs on the proximal side. The implant is offered in multiple combinations of diameter and length to accommodate various anatomies.
- . The dynaMÄ™ Intramedullary Implant is made of biocompatible Nitinol. The barbs of the implant are designed to exhibit superelastic properties at room and body temperature.
- . As manufactured, one end of the implant has a screw thread, and the other end a pair of barbs. The screw thread is inserted into a drilled hole in the middle phalange. The barbed end is implanted into a broached canal in the proximal phalange. While inserting the barbed end of the implant, the barbs deflect inward to allow the implant to pass through the broached canal. Once inside the canal, the barbs superelastically return to their flared outward configuration to securely hold the implant in the bone.
- . The dynaMÄ™ Intramedullary Implant is sold as part of a single use disposable kit. The kit includes an implant, pre-loaded onto a delivery device, a drill bit, a broach and a quide wire.
Indications for Use
The dynaMX™ Intramedullary Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges,
Substantial Equivalence
A series of laboratory studies (bench tests and cadaver tests) have been conducted to verify the suitability of the dynaMX™ Intramedullary Implant for its intended use, establish Substantial Equivalence with the predicate devices and confirm reproducibility of the packaging.
These tests include:
Elastic Static Bending Testing Bending Fatigue Testing Implant Pull-Out Force Rotational Stability Corrosion Testina Transformation Temperature Determination Package Seal Strength Verification Shelf Life
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The biocompatibility of Nitinol has been well-established. A reference publication that describes the biocompatibility was appended, together with a copy of the shelf-life / stability protocol that has been designed to support expiry dating of up to 36 months.
Endotoxin testing of the dynaMX™ Intramedullary Implant has been conducted to confirm that the implant is non-pyrogenic.
This submission supports the position that the MX Orthopedics dynaMX™ Intramedullary Implant is substantially equivalent to previously cleared devices, including the devices listed above. A number of predicate devices list the same range of clinical uses.
Conclusions
MX Orthopedics, Corp. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the MX Orthopedics dynaMX™ Intramedullary Implant. The materials from which the MX Orthopedics device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.
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SUBSTANTIAL EQUIVALENCE INFORMATION
| M X Orthopedics,Corp. | DePuy Inc. | OrthoHelix | Wright Medical | BioMedicalEnterprises | MemometalTechnologies | |
|---|---|---|---|---|---|---|
| dynaMX™Intramedullary Implant | Sterile Kirschner Wiresand Steinmann Pins | Intraosseous FixationSystem | PRO-TOE®Hammertoe FixationSystem | HammerLock® 2 | Smart Toe and X-Fuse® | |
| 510(k) K170326 | 510(k) K960385 | 510(k) K120165 | 510(k) K140148 | 510(k) K133520 | 510(k) K070598 | |
| Similarities | ||||||
| Device is indicated forstabilizing and aiding inthe fixation of fractures,fusions, andosteotomies of thephalanges. | Device is indicated forfixation of bonefractures, for bonereconstruction, as guidepins for insertion ofother implants. | Device is intended tostabilize and aid in thefixation of fractures,fusions, andosteotomies of thephalanges. | Device is indicated forthe fixation ofosteotomies andreconstruction of thelesser toes followingcorrection procedures. | Device is indicated forsmall bonereconstruction andfusion such as inter-digital fusion of fingersand toes. | Device is indicated forsmall bonereconstruction limited tointer-digital fusion offingers and toes andsmall bones fusions. | |
| Product code: HTY -Class II | Product code: HTY andJDW - Class II 21 CFR | Product code: HTY -Class II 21 CFR | Product code: HWCand JDW - Class II 21 | Product code: HTY -Class II 21 CFR | Product code: HTY -Class II 21 CFR | |
| 21 CFR 888.3040 | 888.3040 | 888.3040 | CFR 888.3040 | 888.3040 | 888.3040 | |
| Prescription use in ORsetting | Prescription use in ORsetting | Prescription use in ORsetting | Prescription use in ORsetting | Prescription use in ORsetting | Prescription use in ORsetting | |
| Implant is barbed onone side, threaded onthe other | Device may bethreaded or smooth | Implant is barbed onone side, threaded onthe other | Implant is barbed onone side, threaded onthe other | Implant is barbed onboth sides | Implant is barbed onboth sides | |
| Middle phalangeengaged with 4.0 to4.5mm thread diameter. | Range in diameter from0.7mm to 4.7mm | Middle phalangeengaged with 4.2 to4.5mm thread diameter | Middle phalangeengaged with 4.0mmthread diameter. | Middle phalangeengaged with 5.0 to7.0mm superelasticbarbs | Middle phalangeengaged with 6.6mmsuperelastic barbs | |
| Proximal phalangeengaged with 6.3mmsuperelastic barbs. | Range in diameter from0.7mm to 4.7mm | Proximal phalangeengaged with 2.2 to2.9mm barbs. | Proximal phalangeengaged with 2.0 to3.5mm screw threads. | Proximal phalangeengaged with 5.0 to6.0mm barbs. | Proximal phalangeengaged with 6.0 to7.0mm shape memorybase. | |
| Polished andchemically passivated | Polished andchemically passivated | Polished andchemically passivated | Polished andchemically passivated | Polished andchemically passivated | Polished andchemically passivated | |
| Device is one-component construction | Device is one-component construction | Device is one-component construction | Device is one-component construction | Device is one-component construction | Device is one-component construction | |
| Device is delivered intopre-drilled and pre-broached channels | No pre-drilling orbroaching required | Device is delivered intopre-drilled and pre-broached channels | Device is delivered intopre-drilled and pre-broached channels | Device is delivered intopre-drilled and pre-broached channels | Device is delivered intopre-drilled and pre-broached channels | |
| Repaired toe is straight | Repaired toe is straight | Repaired toe is straight | Repaired toe is straightor 10° | Repaired toe is straightor 10° | Repaired toe is straightor 10° | |
| Device is intended aspermanent implant | Device is intended astemporary implant | Device is intended aspermanent implant | Device is intended aspermanent implant | Device is intended aspermanent implant | Device is intended aspermanent implant | |
| Device is radiopaque | Device is radiopaque | Device is radiopaque | Device is radiopaque | Device is radiopaque | Device is radiopaque |
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Differences
| Device is fabricatedfrom Nitinol per ASTMF2063-12 | Device is fabricatedfrom 316 LVM StainlessSteel | Device is fabricatedfrom stainless steel | Device is fabricatedfrom stainless steel ortitanium | Device is fabricatedfrom Nitinol per ASTMF2063-12 | Device is fabricatedfrom Nitinol per ASTMF2063-12 |
|---|---|---|---|---|---|
| Nitinol materialprovides fixation torepair | Nitinol not used | Nitinol not used | Nitinol not used | Nitinol materialprovides fixation torepair | Nitinol materialprovides fixation torepair |
| Device is provided withsingle-use, sterileaccessory delivery tools | Device provided withoutaccessories | Part of a reusable kit | Part of a reusable kit | Device is provided withsingle-use, sterileaccessory delivery tools | Part of a reusable kit |
| Implant is available in13mm, 14mm, and15mm lengths | Device is available inlengths ranging from 4"to 9" | Implant is available in12mm, 13mm, and14mm lengths | Implant is available in13mm and 16mmlengths. | Implant is available in17mm to 22mmlengths. | Implant is available in15mm to 22mmlengths. |
| Initial proposed shelf-life 6 months followingcompletion of initialshelf-life study | Shelf-life 3 years | Shelf-life 3 years | Shelf-life 3 years | Shelf-life 5 years | Shelf-life 3 years |
| Device is providedsterile by gammaradiation and stored atroom temperature forsingle-patient-use | Device is providedsterile or non-sterile. | Device is provided non-sterile. | Device is provided non-sterile. | Device is providedsterile and stored atroom temperature forsingle patient use. | Device is providedsterile and stored coldfor single patient use. |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.