dynaMX Intramedullary Implant

• K Number: K170326
• Device Name: dynaMX Intramedullary Implant
• Manufacturer: Arthrex, Inc.
• Date Cleared: 2017-07-20 ( 168 days)
• Product Code: HTY HWC
• Regulation Number: 888.3040

Intended Use

The dynaMX™ Intramedullary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

Device 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 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.

Predicate Devices

K960385, K120165, K140148, K133520, K070598

Reference Devices

K960385, K120165, K140148, K133520, K070598

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the mechanical properties and design of the implant and delivery system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is described as an "Intramedullary Fixation Device" and its intended use is to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges," which are all therapeutic interventions.

Diagnostic

No

The device is an intramedullary fixation device used to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges. Its function is to support and fix bones, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical implant made of Nitinol, along with associated surgical tools (delivery device, drill bit, broach, guide wire). This is a hardware medical device, not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Description: The dynaMX™ Intramedullary Fixation Device is a physical implant made of Nitinol designed to be surgically inserted into the phalanges to stabilize fractures, fusions, and osteotomies. It is a mechanical device used within the body, not a test performed on a sample outside the body.
• Intended Use: The intended use is to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges." This is a therapeutic and structural function, not a diagnostic one.

The information provided clearly describes a surgical implant used for orthopedic fixation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The dynaMX™ Intramedulary Fixation Device is indicated to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

Product codes

HTY

Device 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

phalanges

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use (Part 21 CFR 801 Subpart D)
OR setting

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 Testing, Transformation Temperature Determination, Package Seal Strength Verification, Shelf Life.

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.

Key Metrics

Not Found

Predicate Device(s)

K960385, K120165, K140148, K133520, K070598

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

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 [phone] or [phone] 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 [phone] or [phone] 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)

K170326

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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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 Schrayer
Regulatory Affairs Consultant |
| Address: | 1050 Waltham St. Suite 510
Lexington, 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 | BioMedical
Enterprises | Memometal
Technologies | |
|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|
| dynaMX™
Intramedullary Implant | Sterile Kirschner Wires
and Steinmann Pins | Intraosseous Fixation
System | PRO-TOE®
Hammertoe Fixation
System | 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 for
stabilizing and aiding in
the fixation of fractures,
fusions, and
osteotomies of the
phalanges. | Device is indicated for
fixation of bone
fractures, for bone
reconstruction, as guide
pins for insertion of
other implants. | Device is intended to
stabilize and aid in the
fixation of fractures,
fusions, and
osteotomies of the
phalanges. | Device is indicated for
the fixation of
osteotomies and
reconstruction of the
lesser toes following
correction procedures. | Device is indicated for
small bone
reconstruction and
fusion such as inter-
digital fusion of fingers
and toes. | Device is indicated for
small bone
reconstruction limited to
inter-digital fusion of
fingers and toes and
small bones fusions. | |
| Product code: HTY -
Class II | Product code: HTY and
JDW - Class II 21 CFR | Product code: HTY -
Class II 21 CFR | Product code: HWC
and 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 OR
setting | Prescription use in OR
setting | Prescription use in OR
setting | Prescription use in OR
setting | Prescription use in OR
setting | Prescription use in OR
setting | |
| Implant is barbed on
one side, threaded on
the other | Device may be
threaded or smooth | Implant is barbed on
one side, threaded on
the other | Implant is barbed on
one side, threaded on
the other | Implant is barbed on
both sides | Implant is barbed on
both sides | |
| Middle phalange
engaged with 4.0 to
4.5mm thread diameter. | Range in diameter from
0.7mm to 4.7mm | Middle phalange
engaged with 4.2 to
4.5mm thread diameter | Middle phalange
engaged with 4.0mm
thread diameter. | Middle phalange
engaged with 5.0 to
7.0mm superelastic
barbs | Middle phalange
engaged with 6.6mm
superelastic barbs | |
| Proximal phalange
engaged with 6.3mm
superelastic barbs. | Range in diameter from
0.7mm to 4.7mm | Proximal phalange
engaged with 2.2 to
2.9mm barbs. | Proximal phalange
engaged with 2.0 to
3.5mm screw threads. | Proximal phalange
engaged with 5.0 to
6.0mm barbs. | Proximal phalange
engaged with 6.0 to
7.0mm shape memory
base. | |
| Polished and
chemically passivated | Polished and
chemically passivated | Polished and
chemically passivated | Polished and
chemically passivated | Polished and
chemically passivated | Polished and
chemically 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 into
pre-drilled and pre-
broached channels | No pre-drilling or
broaching required | Device is delivered into
pre-drilled and pre-
broached channels | Device is delivered into
pre-drilled and pre-
broached channels | Device is delivered into
pre-drilled and pre-
broached channels | Device is delivered into
pre-drilled and pre-
broached channels | |
| Repaired toe is straight | Repaired toe is straight | Repaired toe is straight | Repaired toe is straight
or 10° | Repaired toe is straight
or 10° | Repaired toe is straight
or 10° | |
| Device is intended as
permanent implant | Device is intended as
temporary implant | Device is intended as
permanent implant | Device is intended as
permanent implant | Device is intended as
permanent implant | Device is intended as
permanent 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 fabricated
from Nitinol per ASTM
F2063-12 | Device is fabricated
from 316 LVM Stainless
Steel | Device is fabricated
from stainless steel | Device is fabricated
from stainless steel or
titanium | Device is fabricated
from Nitinol per ASTM
F2063-12 | Device is fabricated
from Nitinol per ASTM
F2063-12 |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Nitinol material
provides fixation to
repair | Nitinol not used | Nitinol not used | Nitinol not used | Nitinol material
provides fixation to
repair | Nitinol material
provides fixation to
repair |
| Device is provided with
single-use, sterile
accessory delivery tools | Device provided without
accessories | Part of a reusable kit | Part of a reusable kit | Device is provided with
single-use, sterile
accessory delivery tools | Part of a reusable kit |
| Implant is available in
13mm, 14mm, and
15mm lengths | Device is available in
lengths ranging from 4"
to 9" | Implant is available in
12mm, 13mm, and
14mm lengths | Implant is available in
13mm and 16mm
lengths. | Implant is available in
17mm to 22mm
lengths. | Implant is available in
15mm to 22mm
lengths. |
| Initial proposed shelf-
life 6 months following
completion of initial
shelf-life study | Shelf-life 3 years | Shelf-life 3 years | Shelf-life 3 years | Shelf-life 5 years | Shelf-life 3 years |
| Device is provided
sterile by gamma
radiation and stored at
room temperature for
single-patient-use | Device is provided
sterile or non-sterile. | Device is provided non-
sterile. | Device is provided non-
sterile. | Device is provided
sterile and stored at
room temperature for
single patient use. | Device is provided
sterile and stored cold
for single patient use. |