K Number
K210157
Device Name
SOLE Medial Column Fusion Plate
Manufacturer
Date Cleared
2021-04-20

(89 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include: - Arthrodesis; - Joint depression stabilization; - Fracture and/or osteotomy fixation; - Reconstruction; - Revision to be performed for conditions such as Charcot neuroarthropathy.
Device Description
The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle. The implants will be offered both in sterile and non-sterile packaging configurations. Plates and screws are intended for single use only. Screws are not intended for use in the spine. The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138. Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument. These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6). SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.
More Information

No
The device description and intended use focus solely on the mechanical properties and application of a bone fusion plate and associated hardware. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML.

No
The device is a fusion plate and screws primarily used for bone fixation and stabilization, not to restore or improve a physiological function as a therapeutic device would.

No

This device is a surgical implant (plate and screws) used for bone fixation and fusion, not for diagnosing conditions.

No

The device description explicitly states it consists of physical components like plates and screws made of stainless steel, intended for surgical implantation. It also mentions surgical instruments. This is a hardware medical device, not software-only.

Based on the provided text, the SOLE™ Medial Column Fusion Plate is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The SOLE™ Medial Column Fusion Plate is a physical implant designed to provide bone fixation within the foot and ankle. It is surgically implanted into the patient's body.
  • Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical support and fixation of bone.

Therefore, the SOLE™ Medial Column Fusion Plate falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation. The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include:

  • Arthrodesis;
  • Joint depression stabilization;
  • Fracture and/or osteotomy fixation;
  • Reconstruction;
  • Revision
    to be performed for conditions such as Charcot neuroarthropathy.

Product codes (comma separated list FDA assigned to the subject device)

HRS, HWC

Device Description

The SOLE™ Medial Column Fusion Plate consists of plate's sizes and shapes ranges, designed to accept locking and non-locking bone screws, which are available in a variety of diameters and lengths, in order to address demands of stabilization, fixation and fusion of small bones and small joints within the anatomical area of the foot and ankle.
The implants will be offered both in sterile and non-sterile packaging configurations.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
The Subject device implants, bone plates and bone screws, are made from Stainless Steel AISI 316 LVM according to Standard ISO 5832-1/ASTM F138.
Surgical procedures with the use of the subject implants may be performed with the support of general orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. The instruments offered by Orthofix are classified as class I devices Exempt from 510(k), under the product code LXH, according to 21CFR 888.4540 Orthopedic Manual surgical instrument.
These instruments are made by medical grade stainless steel (AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and Aluminum alloy (EN-AW 6082 T6).
SOLE™ Medial Column Fusion Plate is designed to be used in the operating theatre only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Operating theatre only.

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)

Performance mechanical testing on Subject implants item have been performed according to: ASTM F543-17 "Standard Specification and Test Methods for Metallic Medical Bone Screws", ASTM F382 standard "Standard Specification And Test Method For Metallic Bone Plates", ASTM F543-17 "Standard Specification and Test Methods for Metallic Medical Bone Screws".
Performance mechanical testing specifications on Subject instruments according to standard ASTM F899-12b "Standard Specification For Wrought Stainless Steels for Surgical Instruments".
Results to support the determination of substantial equivalence from bench testing and engineering assessments on worst cases of Subject device and corresponding predicate devices and other similar devices, confirm that Subject device, as safe, as effective, and performs as well as or better than the predicate devices.
The review of the current clinical literature on the predicates and on other similar devices have been conducted to support the clinical indications of SOLE™ Medial Column Fusion Plate without requiring further clinical data.

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.

K203511, K180500, K090675, K140792

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.

K974186, K053261, K173458

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

§ 888.3030 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.

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April 20, 2021

Image /page/0/Picture/1 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, with 'ADMINISTRATION' written below in a smaller font.

Orthofix SRL % Cheryl Wagoner Consultant Wagoner Consulting LLC PO Box 15729 Wilmington, North Carolina 28408

Re: K210157

Trade/Device Name: SOLE™ Medial Column Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: January 21, 2021 Received: January 21, 2021

Dear Cheryl Wagoner:

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

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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 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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)

K210157

Device Name SOLETM Medial Column Fusion Plate

Indications for Use (Describe)

The SOLE™ Medial Column Fusion Plate is intended to provide bone fixation.

The SOLE™ Medial Column Fusion Plate is indicated for orthopedic applications within the anatomical area of the foot and ankle, including but not limited to the medial column (consisting of the first metatarsal, medial cuneiform, navicular and talus). Specific indicated procedures include:

  • Arthrodesis;

  • Joint depression stabilization;

  • Fracture and/or osteotomy fixation;

  • Reconstruction;

  • Revision

to be performed for conditions such as Charcot neuroarthropathy.

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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Submitter information

Submitter NameOrthofix Srl
AddressVia delle Nazioni, 9 37012 Bussolengo (VR) - Italy
Telephone+ 39 045 6719.000
Fax+ 39 045 6719.380

| Contact Person | Gianluca Ricadona
Sr. Quality & Regulatory Affairs Manager |
|--------------------|---------------------------------------------------------------|
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy |
| Telephone | + 39 045 6719 000 |
| Fax | + 39 045 6719 380 |
| Email address | GianlucaRicadona@orthofix.it |
| Date of submission | April 16, 2021 |

Trade Name, Common Name, Classification

Trade NameSOLE™ Medial Column Fusion Plate
DevicePlate, fixation, bone (Primary)
Screw, fixation, bone
Product codeHRS (Primary)
HWC
Panel CodeOrthopedic
ClassClass II
Regulation Number21 CFR §888.3030 (Primary): Single/multiple component
metallic bone fixation appliances and accessories;
21 CFR §888.3040: Smooth or threaded metallic bone fixation
fastener; Class II

Predicate devices and reference devices

| Primary Predicate Device | 510(k)
Number | Manufacturer |
|-----------------------------------------------------------------------------|------------------|---------------------|
| Baby Gorilla/Gorilla Plating System (formerly
ParaLock Plating SystemTM) | K203511 | Paragon 28, Inc. |
| Additional Predicate Devices | | |
| VariAx 2 System | K180500 | Stryker GmbH |
| VLP Foot, Plating, Screw System | K090675 | Smith & Nephew, Inc |
| Salvation 3Di Plating System | K140792 | Wright Medical |
| Reference Devices | | |
| Orthofix Fixation Screws with HA coated | K974186 | Orthofix Srl |
| Veronail Screwdriver instrument | K053261 | Orthofix Srl |
| Chimaera - Hip Fracture System | K173458 | Orthofix Srl |

| Device description | The SOLE™ Medial Column Fusion Plate consists of plate's
sizes and shapes ranges, designed to accept locking and non-
locking bone screws, which are available in a variety of
diameters and lengths, in order to address demands of
stabilization, fixation and fusion of small bones and small joints
within the anatomical area of the foot and ankle. |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The implants will be offered both in sterile and non-sterile
packaging configurations. |
| | Plates and screws are intended for single use only. Screws are
not intended for use in the spine. |
| | The Subject device implants, bone plates and bone screws, are
made from Stainless Steel AISI 316 LVM according to Standard
ISO 5832-1/ASTM F138. |
| | Surgical procedures with the use of the subject implants may be
performed with the support of general orthopedic
instrumentation, to facilitate their proper insertion and removal
from the patient. The instruments offered by Orthofix are
classified as class I devices Exempt from 510(k), under the
product code LXH, according to 21CFR 888.4540 Orthopedic
Manual surgical instrument. |
| | These instruments are made by medical grade stainless steel
(AISI 316LVM, AISI 630, AISI 301, AISI 303, X15TN) and
Aluminum alloy (EN-AW 6082 T6). |
| | SOLE™ Medial Column Fusion Plate is designed to be used in
the operating theatre only. |
| Indications for use | The SOLE™ Medial Column Fusion Plate is intended to provide
bone fixation. The SOLE™ Medial Column Fusion Plate is
indicated for orthopedic applications within the anatomical area
of the foot and ankle, including but not limited to the medial
column (consisting of the first metatarsal, medial cuneiform,
navicular and talus). Specific indicated procedures include:

  • Arthrodesis;
  • Joint depression stabilization;
  • Fracture and/or osteotomy fixation;
  • Reconstruction;
  • Revision
    to be performed for conditions such as Charcot
    neuroarthropathy. |
    | Technological
    Characteristics and
    Intended Use | The Subject device fundamental scientific principles and
    technological characteristic, including: the intended use, material
    and general design, are the same as, or similar to, the chosen
    predicate devices.
    Summary of the technological characteristics and Intended Use:
    ✓ Intended use: identical.
    ✓ Indications for Use, Anatomical sites, operating principles
    and conditions of use: are substantially equivalent to
    predicates; no new risks associated to the Subject device
    compared to those of the Primary predicate and the
    additional predicate device which have equivalent indications
    for use, anatomical sites and conditions of use. Verification
    activities on Subject devices demonstrated substantially
    equivalent performance to the predicate devices.
    ✓ Geometry and size: similar sizes and geometry of the bone
    plates; similar sizes and geometry of the bone screws.
    ✓ Sterilization, same method as the predicates. |
    | | The technological characteristics of the SOLE™ Medial Column
    Fusion Plate are substantially equivalent to the predicate
    devices. |
    | Performance
    Analysis | Subject device has similar configuration, sizes and design as the
    predicate devices.
    Results to support the determination of substantial equivalence
    from bench testing and engineering assessments on worst cases
    of Subject device and corresponding predicate devices and other
    similar devices, confirm that Subject device, as safe, as
    effective, and performs as well as or better than the predicate
    devices.
    Performance mechanical testing on Subject implants item have
    been performed according to: ASTM F543-17 "Standard
    Specification and Test Methods for Metallic Medical Bone
    Screws", ASTM F382 standard "Standard Specification And Test
    Method For Metallic Bone Plates", ASTM F543-17 "Standard
    Specification and Test Methods for Metallic Medical Bone
    Screws".
    Performance mechanical testing specifications on Subject
    instruments according to standard ASTM F899-12b "Standard
    Specification for Wrought Stainless Steels for Surgical
    Instruments".
    Any potential hazards have been evaluated and controlled
    through Risk Management activities, and any relevant
    information, have been addressed in the labelling, after all
    control measures have been implemented.
    The review of the current clinical literature on the predicates and
    on other similar devices have been conducted to support the
    clinical indications of SOLE™ Medial Column Fusion Plate
    without requiring further clinical data. |
    | Conclusion | Based upon equivalences in: intended use, site of application,
    conditions of use, operating principles, and the non-clinical
    performance data, the SOLE™ Medial Column Fusion Plate has
    been shown to be safe and effective, and to perform equivalently
    as compared to the legally marketed predicate devices.
    Therefore, the Subject device is substantially equivalent to the
    legally marketed predicate devices. |

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