(44 days)
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing.
Yes
The device is intended to stabilize fractures and treat malunions and non-unions, which are direct medical interventions for disease or injury.
No
The device is an intramedullary nail system intended to stabilize fractures, malunions, and non-unions of the tibia. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of physical components (intramedullary nail, locking screws, end caps) made of Ti-6Al-4V ELI, which are hardware implants.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing fractures of the tibia. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of an intramedullary nail, locking screws, and end caps, all made of titanium. These are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used to treat a physical condition (fractures).
N/A
Intended Use / 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 post-isthmic fractures; and tibial malunions and non-unions.
Product codes (comma separated list FDA assigned to the subject device)
HSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence to the predicate devices was determined through comparison of mechanical testing results, indications and intended uses, and device function. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zimmer M/DN Intramedullary Fixation System (K142281)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Synthes Tibial Nail System EX (K040762), Ellipse Technologies Incorporated PRECICE Trauma Nail System (K152370)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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."
3
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
65 Main Street
Potsdam, NY 13676 |
|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/01/2021 |
| Contact Person:
Contact Telephone:
Contact Fax: | Kyle Kovach, Quality and Regulatory Engineer
(440) 787-5832
(440) 933-7839 |
| Device Trade Name:
Device Classification Name:
Device Classification:
Reviewing Panel:
Product Code:
Common Name: | Adaptable Ortho Innovations Intramedullary Nail System
Intramedullary Fixation Rod (21 CFR 888.3020)
Class II
Orthopedic
HSB
Rod, fixation, intramedullary and accessories |
| Predicate Devices: | Primary Predicate: Zimmer M/DN Intramedullary Fixation System
(K142281).
Reference Predicate: Synthes Tibial Nail System EX (K040762).
Reference Predicate: Ellipse Technologies Incorporated PRECICE
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.
4
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
Ortho
Innovations
Intramedullary
Nail System | Zimmer M/DN
Intramedullary
Fixation System
(K142281) | Synthes
Tibial Nail
System EX
(K040762) | Ellipse
Technologies
Incorporated
PRECICE
Trauma Nail
System
(K152370) | INNOVATIONS | | | | |
|------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Rod, fixation,
intramedullary
and accessories | Rod, fixation,
intramedullary
and accessories | Rod, fixation,
intramedullary
and
accessories | Intramedullary
Fixation Rod | Material | Ti-6Al-4V ELI
per ASTM F136 | Stainless steel | Titanium
alloy | Ti-6Al-4V ELI
per ASTM F136 |
| Regulation | 21 CFR 888.3020 | 21 CFR 888.3020 | 21 CFR
888.3030 | 21 CFR
888.3020 | System
Implanted
Components | Proximal and
distal nail shafts,
locking nut,
locking screws,
nail cap | Cannulated
intramedullary
nail, locking
screws, nail cap,
cortical nuts and
washers | Cannulated
tibial nail,
locking
screws and
bolts, endcap | Trauma nail
containing rare
earth magnet,
telescoping lead
screw/nut
assembly, and
planetary
gearing, locking
screws, end cap |
| Product Code | HSB | HSB | JDS | HSB | Adjustable
Nail Length? | Yes | No | No | Yes |
| Nail Lengths | Adjustable 245-
290, 285-350,
345-400 mm | 18, 20, 22, 24,
26, 28, 30, 32,
34, 36, 38, 40,
42, 44, 46 cm | 255, 270, 285,
300, 315, 330,
345, 360, 375,
390, 405, 420,
435 mm | 155, 160, 180,
195, 215, 230,
245, 275, 305,
335, 365 mm | Implant
Location | Tibia | Tibia, Femur,
Humerus | Tibia | Tibia, Femur,
Humerus |
| Nail
Diameters | 9.5, 11.0, 13.0
mm | 6, 7, 8, 9, 10, 11,
12, 13, 14, 15
mm | 8.0, 9.0, 10.0,
11.0, 12.0,
13.0 mm | 8.5, 10.7, 12.5
mm | | | | screws: 4.0,
5.0 mm
Dual-core
locking
screws: 3.4,
4.3 mm | |
| Screw
Lengths | 25-75 mm in 5
mm increments | 20-90 mm | Standard
locking
screws: 18-80
mm in 2 mm
increments
(4.0 mm
diameter), 26-
80 mm in 2
mm
increments or
85-100 mm in
5 mm
increments
(5.0 mm
diameter)
Dual-core
locking
screws: 30-90
mm in 5 mm
increments | 20-75 mm in 5
mm increments | | | | | |
| Screw
Diameters | 3.7 mm, 4.5 mm | 4.2, 3.7 mm | Standard
locking | 3.5, 4.0, 5.0 mm | | | | | |
5
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.
6
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.