Adaptable Ortho Innovations Intramedullary Nail System

K210285 · Adaptable Ortho Innovations, LLC · HSB · Mar 18, 2021 · Orthopedic

Device Facts

• Record ID: K210285
• Device Name: Adaptable Ortho Innovations Intramedullary Nail System
• Applicant: Adaptable Ortho Innovations, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Mar 18, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Device Story

The Adaptable Ortho Innovations Intramedullary Nail System is an orthopedic implant used to stabilize tibial fractures. It consists of an adjustable-length intramedullary nail, locking screws, and end caps. The device features two nail shaft components that are threaded together and locked with a nut during surgery to achieve a specific length, after which it functions similarly to a single-piece nail. It is implanted into the tibia by a surgeon using standard orthopedic instrumentation. The device provides mechanical stability to bone fractures, facilitating healing. It is supplied sterile via gamma irradiation.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through bench testing, including static 4-point bending, static torsion, static axial compression, dynamic axial compression, and dynamic bending fatigue testing for both nail and screw components, conducted in accordance with ASTM F1264 and ASTM F543 standards.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Components: Adjustable-length intramedullary nail (two-piece shaft with locking nut), locking screws, end caps. Sterilization: Gamma irradiation (SAL 10^-6). Mechanical testing standards: ASTM F1264, ASTM F543. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring stabilization of proximal/distal tibia fractures, tibial shaft fractures (open/closed), pre- and post-isthmic fractures, and tibial malunions or non-unions.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Zimmer M/DN Intramedullary Fixation System (K142281)

Reference Devices

• Synthes Tibial Nail System EX (K040762)
• Ellipse Technologies Incorporated PRECICE Trauma Nail System (K152370)

Submission Summary (Full Text)

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March 18, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Adaptable Ortho Innovations, LLC % Kyle Kovach Quality and Regulatory Engineer JALEX Medical 27865 Clemens Road, Suite #3 Westlake, Ohio 44145

# Re: K210285

Trade/Device Name: Adaptable Ortho Innovations Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 1, 2021 Received: February 2, 2021

## Dear Kyle Kovach:

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 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

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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 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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Michael Owens 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

510(k) Number (if known) K210285

Device Name

Adaptable Ortho Innovations Intramedullary Nail System

Indications for Use (Describe)

The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

| 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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Image /page/3/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" inside a circle, with a purple dot above the "A". Below the circle, the words "ADAPTABLE ORTHO" are written in a larger, bolder font, and the word "INNOVATIONS" is written below in a smaller, lighter font. The overall design is clean and modern.

# 510(k) Summary

| Submitted By: | Adaptable Ortho Innovations, LLC<br>65 Main Street<br>Potsdam, NY 13676 |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/01/2021 |
| Contact Person:<br>Contact Telephone:<br>Contact Fax: | Kyle Kovach, Quality and Regulatory Engineer<br>[phone]<br>[phone] |
| Device Trade Name:<br>Device Classification Name:<br>Device Classification:<br>Reviewing Panel:<br>Product Code:<br>Common Name: | Adaptable Ortho Innovations Intramedullary Nail System<br>Intramedullary Fixation Rod (21 CFR 888.3020)<br>Class II<br>Orthopedic<br>HSB<br>Rod, fixation, intramedullary and accessories |
| Predicate Devices: | Primary Predicate: Zimmer M/DN Intramedullary Fixation System<br>(K142281).<br>Reference Predicate: Synthes Tibial Nail System EX (K040762).<br>Reference Predicate: Ellipse Technologies Incorporated PRECICE<br>Trauma Nail System (K152370). |

#### Device Description:

The Adaptable Ortho Innovations Intramedullary Nail System consists of an adjustable length intramedullary nail, locking screws, and end caps. All implants are manufactured from Ti-6Al-4V ELI per ASTM F136. The nail system is available in a range of lengths and diameters to accommodate varying patient anatomy.

#### Indications for Use:

The Adaptable Ortho Innovations Intramedullary Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and postisthmic fractures; and tibial malunions and non-unions.

### Comparison of Technological Characteristics with Predicate devices:

The Adaptable Ortho Innovations Intramedullary Nail System and the predicates have the same intended use and fundamental scientific technology. A comparison table of the subject device and predicate devices technological characteristics is provided in this submission in Section XIV Substantial Equivalence. A condensed comparison table is also presented below. There are no differences in technological characteristics that raise questions of safety and efficacy.

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Image /page/4/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" with a purple circle above it. Inside the "A" is a depiction of a leg brace. The text "ADAPTABLE ORTHO INNOVATIONS" is written in a simple sans-serif font below the logo.

# Table 1: Dimensions and Technological Characteristics Comparison

| Item | Adaptable<br>Ortho<br>Innovations<br>Intramedullary<br>Nail System | Zimmer M/DN<br>Intramedullary<br>Fixation System<br>(K142281) | Synthes<br>Tibial Nail<br>System EX<br>(K040762) | Ellipse<br>Technologies<br>Incorporated<br>PRECICE<br>Trauma Nail<br>System<br>(K152370) | INNOVATIONS | | | | |
|------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Rod, fixation,<br>intramedullary<br>and accessories | Rod, fixation,<br>intramedullary<br>and accessories | Rod, fixation,<br>intramedullary<br>and<br>accessories | Intramedullary<br>Fixation Rod | Material | Ti-6Al-4V ELI<br>per ASTM F136 | Stainless steel | Titanium<br>alloy | Ti-6Al-4V ELI<br>per ASTM F136 |
| Regulation | 21 CFR 888.3020 | 21 CFR 888.3020 | 21 CFR<br>888.3030 | 21 CFR<br>888.3020 | System<br>Implanted<br>Components | Proximal and<br>distal nail shafts,<br>locking nut,<br>locking screws,<br>nail cap | Cannulated<br>intramedullary<br>nail, locking<br>screws, nail cap,<br>cortical nuts and<br>washers | Cannulated<br>tibial nail,<br>locking<br>screws and<br>bolts, endcap | Trauma nail<br>containing rare<br>earth magnet,<br>telescoping lead<br>screw/nut<br>assembly, and<br>planetary<br>gearing, locking<br>screws, end cap |
| Product Code | HSB | HSB | JDS | HSB | Adjustable<br>Nail Length? | Yes | No | No | Yes |
| Nail Lengths | Adjustable 245-<br>290, 285-350,<br>345-400 mm | 18, 20, 22, 24,<br>26, 28, 30, 32,<br>34, 36, 38, 40,<br>42, 44, 46 cm | 255, 270, 285,<br>300, 315, 330,<br>345, 360, 375,<br>390, 405, 420,<br>435 mm | 155, 160, 180,<br>195, 215, 230,<br>245, 275, 305,<br>335, 365 mm | Implant<br>Location | Tibia | Tibia, Femur,<br>Humerus | Tibia | Tibia, Femur,<br>Humerus |
| Nail<br>Diameters | 9.5, 11.0, 13.0<br>mm | 6, 7, 8, 9, 10, 11,<br>12, 13, 14, 15<br>mm | 8.0, 9.0, 10.0,<br>11.0, 12.0,<br>13.0 mm | 8.5, 10.7, 12.5<br>mm | | | | screws: 4.0,<br>5.0 mm<br><br>Dual-core<br>locking<br>screws: 3.4,<br>4.3 mm | |
| Screw<br>Lengths | 25-75 mm in 5<br>mm increments | 20-90 mm | Standard<br>locking<br>screws: 18-80<br>mm in 2 mm<br>increments<br>(4.0 mm<br>diameter), 26-<br>80 mm in 2<br>mm<br>increments or<br>85-100 mm in<br>5 mm<br>increments<br>(5.0 mm<br>diameter)<br><br>Dual-core<br>locking<br>screws: 30-90<br>mm in 5 mm<br>increments | 20-75 mm in 5<br>mm increments | | | | | |
| Screw<br>Diameters | 3.7 mm, 4.5 mm | 4.2, 3.7 mm | Standard<br>locking | 3.5, 4.0, 5.0 mm | | | | | |

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Image /page/5/Picture/1 description: The image is a logo for Adaptable Ortho Innovations. The logo features a stylized letter "A" with a circle around it. The letter "A" is purple and gray, and the circle is gray. The text "ADAPTABLE ORTHO" is below the logo in purple, and the text "INNOVATIONS" is below that in gray. The logo is simple and modern, and it conveys a sense of innovation and adaptability.

The subject and predicate devices compare similarly in the dimensions and materials of their nails and screws and are all intended for implantation into the tibia.

The Adaptable Ortho Innovations Intramedullary Nail System is comprised of two nail shaft components, which are threaded together prior to distribution and locked in place by a locking nut during surgery. Once the pre-assembled proximal and distal shafts are adjusted to the desired total length and permanently locked together, the Adaptable Ortho nail is substantially equivalent in form and function to the predicate devices, which utilize a single-piece nail shaft. Both the subject and predicate devices are secured into the bone by locking screws, and capped at the proximal end with an optional nail (end) cap.

## Clinical and Non-Clinical Testing:

All Adaptable Ortho Innovations Intramedullary Nail System implants are delivered sterile and a gamma irradiation sterilization vas performed to validate the sterilization dose and ensure a Sterility Assurance Level (SAL) of 106. Instruments are not provided as part of the system and are intended to be obtained by the user as a general orthopedic instrument set for intramedullary nail insertion. Any instruments chosen should be cleaned and sterilized per the instructions for use specific to those instruments.

Packaging validation was performed to validate a 1 year shelf life for the Adaptable Ortho Innovations Intramedullary Nail System implant through real-time and accelerated aging techniques. The validation study also validated the integrity of the packaging following sterilization and distribution testing.

Clinical testing was not required for this device. Substantial equivalence to the predicate devices was determined through comparison of mechanical testing results, indications and intended uses, and device function.

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Image /page/6/Picture/1 description: The image shows the logo for Adaptable Ortho Innovations. The logo features a stylized letter A with a circle around it. The words "ADAPTABLE ORTHO" are on the first line, and the word "INNOVATIONS" is on the second line.

Substantial equivalence is supported by the results of mechanical testing including static 4-point bending, static torsion, static axial compression, dynamic axial compression, and dynamic bending fatigue (for both the nail and screw components of the system) per ASTM F1264 and ASTM F543. Mechanical testing methods, data, and reports are provided in this submission.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate devices, the subject devices have demonstrated substantial equivalence.