K Number
K232169
Device Name
FITBONE® Transport and Lengthening System
Manufacturer
Date Cleared
2024-03-22

(245 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.
Device Description
The subject “FITBONE® Transport and Lengthening System” consists of the implantable intramedullary transport or lengthening nail and its trial nail accessories. The Subject device is implanted into the medullary canal of the femur or tibia and connected to the additional predicate intracutaneous Receiver by a bipolar feed line. The external FITBONE Control Set is identical to that previously cleared for the additional predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to this previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the FITBONE Transport and Lengthening Nail with voltage, when actioned. The subject nail is anchored to the bone by locking screws through medial-lateral and AP holes in the nail depending on the configuration holes in the nail. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each size model of the FITBONE Transport (TN) and FITBONE Transport or Lengthening (TLN) nails and are used to simulate the shape of the implant. The subject nails and trial nails are provided in sterile conditions only and are made from, as follows: • Nail: implant grade stainless steel 1.4441, according to ASTM F138- 13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED- 1511, Nusil MED 4750). • Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments For the implantation and removal of the subject device the same instruments of the additional predicate Fitbone TAA (K203399) may be used.
More Information

No
The device description focuses on mechanical and electrical components for distraction and lengthening, with no mention of AI or ML algorithms for control, analysis, or decision-making. The performance studies are also focused on mechanical testing.

Yes
The device is indicated for limb lengthening and fixation of fractures, malunions, non-unions, and pseudoarthrosis, all of which are considered therapeutic interventions.

No

Explanation: The device is designed for therapeutic purposes, specifically limb lengthening and fracture fixation, not for detecting, diagnosing, or monitoring medical conditions.

No

The device description clearly outlines multiple hardware components, including an implantable intramedullary nail, a receiver, a control electronics station, a transmitter, and trial nail accessories, all made of physical materials like stainless steel and silicone. The submission also includes bench testing for these physical components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for limb lengthening, fracture fixation, and bone transport of long bones. This is a surgical procedure performed directly on the patient's body.
  • Device Description: The device is an implantable intramedullary nail and associated external control system. It is designed to be surgically implanted into the bone.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.

The device is a surgical implant used for orthopedic procedures, not an in vitro diagnostic test.

N/A

Intended Use / Indications for Use

"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.

Product codes

HSB

Device Description

The subject "FITBONE® Transport and Lengthening System" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The Fitbone Transport and Lengthening System is indicated for adult only. The subject "FITBONE® Transport and Lengthening System" consists of the implantable intramedullary transport or lengthening nail and its trial nail accessories. The Subject device is implanted into the medullary canal of the femur or tibia and connected to the additional predicate intracutaneous Receiver by a bipolar feed line. The external FITBONE Control Set is identical to that previously cleared for the additional predicate Fitbone TAA device (K203399) and consists of a control electronics station and transmitter. There are no changes to this previously cleared Control Sets and Receiver as a result of this submission. The power required for the distraction process is controlled by hermetically enclosed motor which draws the telescope apart. The electro-magnetic field sent from the Transmitter to the Receiver is converted in the Receiver into DC-Voltage to supply the motor of the FITBONE Transport and Lengthening Nail with voltage, when actioned. The subject nail is anchored to the bone by locking screws through medial-lateral and AP holes in the nail depending on the configuration holes in the nail. The energy needed for the distraction process is transmitted from the outside by placing the external transmitter over the implanted receiver, which is placed in the subcutaneous tissue during surgery. There is no transcutaneous contact between the implanted intramedullary nail and the outer surface of the patient's body. The subject trial nails accessories are available for each size model of the FITBONE Transport (TN) and FITBONE Transport or Lengthening (TLN) nails and are used to simulate the shape of the implant. The subject nails and trial nails are provided in sterile conditions only and are made from, as follows: Nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-1511, Nusil MED 4750). Trial nail: implant grade stainless steel 1.4441, according to ASTM F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)" and ASTM F899-20 Standard Specification for Wrought Stainless Steels for Surgical Instruments For the implantation and removal of the subject device the same instruments of the additional predicate Fitbone TAA (K203399) may be used.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Long bones (e.g. femur or tibia)

Indicated Patient Age Range

adult only

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)

Mechanical testing of the subject devices to demonstrate equivalence in function and safety for the intended use of the FITBONE® Transport and Lengthening nails and trial nails in respect to its additional predicate FITBONE® TAA (K203399) have been performed for the following functional attributes and are included in section "Bench Testing" of this eSTAR application form, as below:
Implantable rod: Static 4-point bending test (with Subject FITBONE® Transport and Lengthening nail) performed according to ASTM F1264-16 - Standard Specification and Test Methods for Intramedullary Fixation Devices.
Implantable rod: Fatigue 4-point bending test (with Subject FITBONE® Transport and Lengthening nail) performed according to ASTM F1264-16 - Standard Specification and Test Methods for Intramedullary Fixation Devices. The Fatigue limit calculation are, instead, performed according to ISO 12107:2012 - Metallic materials — Fatigue testing — Statistical planning and analysis of data.
Implantable rod: Torsional test (with Subject FITBONE® Transport and Lengthening nail) performed according to ASTM F1264-16 - Standard Specification and Test Methods for Intramedullary Fixation Devices.
Implantable rod: Absorbed current by the nail's motor during usage when different forces are applied (with Subject FITBONE® Transport and Lengthening nail). The test performed does not refer to any standard since it is designed for this specific component. The test requires the measurement of the current consumption of the motor while running to obtain a displacement when different forces are applied to the actuator.

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.

K201567, K203399

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.

K973944, K961027

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 22, 2024

Image /page/0/Picture/1 description: The image shows 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.

Orthofix S.r.l. Elvira Taccarelli Regulatory Affairs Manager Via Delle Nazioni, 9 Bussolengo (VR), IT 37012 Italy

Re: K232169

Trade/Device Name: FITBONE® Transport and Lengthening System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 13, 2024 Received: March 13, 2024

Dear Elvira Taccarelli:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,

Digitally signed by Farzana Farzana Sharmin -S Date: 2024.03.22 15:20:00 Sharmin -S

Farzana Sharmin, PhD 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

Submission Number (if known)

K232169

Device Name

FITBONE® TRANSPORT AND LENGTHENING SYSTEM

Indications for Use (Describe)

"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The "FITBONE Transport and Lengthening system" is indicated for adult only.

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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3

Image /page/3/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. A small "R" in a circle is located to the right of the "X" in "ORTHOFIX", indicating a registered trademark.

510(K) SUMMARY

ORTHOFIX SRL FITBONE® Transport and Lengthening System

Submitter information

Company Name:Orthofix S.r.l.
AddressVia Delle Nazioni, 9
37012 Bussolengo (VR) - Italy
Telephone+39 045 6719000
Fax+39 045 6719380
Contact PersonElvira Taccarelli
Regulatory Affairs Manager
AddressVia Delle Nazioni, 9
37012 Bussolengo (VR) - Italy
Telephone+39 045 6719000
Fax+39 045 6719380
Email addresselvirataccarelli@orthofix.it
Date prepared2024, January 31

Trade Name, Common Name, Classification

Trade Name:FITBONE® Transport and Lengthening System
Common Name:Intramedullary lengthening nail
Classification Name:Intramedullary fixation rod
Regulation Number:21 CFR 888.3020
Product Code:HSB
Classification:Class II
Panel code:Orthopedic

Primary Predicate and additional predicate device

Primary Predicate510(k) NumberManufacturer
Precice® Bone Transport SystemK201567NuVasive Specialized
Orthopedics Inc.
Additional predicate510(k) NumberManufacturer
FITBONE® TAAK203399Orthofix s.r.l.

Reference devices

Reference Devices510(k) NumberManufacturer
Orthofix Femoral Nailing systemK973944Orthofix s.r.l.
Orthofix Tibial Nailing systemK961027Orthofix s.r.l.

() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy \ \ +39 045 6719380 ✈ orthofix.com

DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)

SEDE LEGAL: VA VITOR RIAN 1 L . P. P.VA 097669150 CE VA NUMER TI097660150 R.E., M 125769 Cap. So. E., M 127769 Cap. So. Eu. 1.56.000 in. ves.

4

Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is located to the right of the "X" in "ORTHOFIX".

| Device description | The subject “FITBONE® Transport and Lengthening System” is
indicated for limb lengthening, open and closed fracture fixation,
pseudoarthrosis, malunions, non-unions, or bone transport of the long
bones. The Fitbone Transport and Lengthening System is indicated for
adult only.
The subject “FITBONE® Transport and Lengthening System” consists
of the implantable intramedullary transport or lengthening nail and its
trial nail accessories. The Subject device is implanted into the
medullary canal of the femur or tibia and connected to the additional
predicate intracutaneous Receiver by a bipolar feed line. The external
FITBONE Control Set is identical to that previously cleared for the
additional predicate Fitbone TAA device (K203399) and consists of a
control electronics station and transmitter. There are no changes to this
previously cleared Control Sets and Receiver as a result of this
submission.
The power required for the distraction process is controlled by
hermetically enclosed motor which draws the telescope apart. The
electro-magnetic field sent from the Transmitter to the Receiver is
converted in the Receiver into DC-Voltage to supply the motor of the
FITBONE Transport and Lengthening Nail with voltage, when actioned.
The subject nail is anchored to the bone by locking screws through
medial-lateral and AP holes in the nail depending on the configuration
holes in the nail. The energy needed for the distraction process is
transmitted from the outside by placing the external transmitter over the
implanted receiver, which is placed in the subcutaneous tissue during
surgery.
There is no transcutaneous contact between the implanted
intramedullary nail and the outer surface of the patient's body.
The subject trial nails accessories are available for each size model of
the FITBONE Transport (TN) and FITBONE Transport or Lengthening
(TLN) nails and are used to simulate the shape of the implant.
The subject nails and trial nails are provided in sterile conditions only
and are made from, as follows:
• Nail: implant grade stainless steel 1.4441, according to ASTM F138-
13 "Standard Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)", and Silicone Nusilmed (NuSil MED-4870, NuSil MED-
1511, Nusil MED 4750).
• Trial nail: implant grade stainless steel 1.4441, according to ASTM
F138-13 "Standard Specification for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)" and ASTM F899-20 Standard Specification for
Wrought Stainless Steels for Surgical Instruments
For the implantation and removal of the subject device the same
instruments of the additional predicate Fitbone TAA (K203399) may be
used. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | "FITBONE Transport and Lengthening system" is indicated for limb
lengthening, open and closed fracture fixation, pseudoarthrosis,
malunions, non-unions, or bone transport of the long bones.
The "FITBONE Transport and Lengthening system" is indicated for
adult only. |
| Technological
Characteristics | The following table provides a comparison and assessment of
fundamental scientific principles and technological characteristics of
the subject, primary predicate and additional predicate devices. Any
differences have been demonstrated to not raise new issues of safety
or performance by virtue of objective evidence (e.g., bench testing,
process validations, etc.). Therefore, the technological characteristics
of the subject FITBONE® Transport and Lengthening system are
equivalent to the primary predicate Precice® Bone Transport System |

() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy ↑ 29 045 6719380 曲 orthofix.com

DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)

5

Image /page/5/Picture/1 description: The image shows the word "ORTHOFIX" in a bold, sans-serif font. To the left of the word is a blue, abstract shape that resembles a stylized "O". A small "R" in a circle is located to the upper right of the word "ORTHOFIX", indicating that it is a registered trademark.

(K201567) and the additional predicate device FITBONE® TAA (K203399).
Technological CharacteristicSubject Device (Fitbone Bone Transport and Lengthening System)Primary Predicate Device (Precice Bone Transport System, K201567)Additional Predicate Device (Fitbone TAA, K203399)
1.Indications for UseIndicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones. The Fitbone Transport and Lengthening System is indicated for adults only.Indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones.Intended for limb lengthening of the femur and tibia. Indicated for adult and pediatric (greater than 12 through 21 years of age) patients
Assessment: The subject indications are identical to the primary predicate and carry the same lengthening indication as the additional predicate. Equivalent - no significant new issues have been raised.
2.Anatomical SitesLong bonesLong bonesFemur, tibia
Assessment: The anatomical sites for use are identical to primary predicate and similar to additional predicate (femur and tibia are long bones). Equivalent - no significant new issues raised.
3.Nail MaterialImplant Grade Stainless Steel (1.4441, 316LVM)Implant Grade Stainless Steel (ASTM F2229, Biodur 108)Implant Grade Stainless Steel (1.4441, 316LVM)
Assessment: Subject material is similar to primary predicate and identical to additional predicate. Both have been demonstrated to be biocompatible implant grade stainless steels with unique corrosion properties. Equivalent - no significant new issues raised.
4.Nail Size Range290-490mm in length; 11 and 13mm diameters in varying configurations280-400mm in length; 10, 11.5, and 13mm diameters in varying configurations200-245mm in length; 9, 11, and 13mm diameters in varying configurations
Assessment: Size ranges of subject are similar to primary and additional predicate. Potential performance differences arising from variations in size offerings have been demonstrated through bench testing to not raise significant new issues. Further mitigation is provided through weight bearing precautions in labeling. The ranges are therefore equivalent.
5.Maximum Stroke Length Available80mm100mm80mm
Assessment: The subject stroke length is within that of primary predicate and identical to the additional predicate. Equivalent - no significant new issues raised.
6.Method of Distraction/Energy SourceInternal motor electro-magnetically induced by an external transmitter with signal received through a receiver placed just underInternal magnetically powered telescopic feature with two rotating magnets induced by an external controllerInternal motor electro-magnetically induced by an external transmitter with signal received through a receiver placed just under
Assessment: Subject distraction methodology is similar to primary predicate and
identical to additional predicate. Differences in technology have been demonstrated
through bench testing to not raise significant new issues. The methods are therefore
equivalent.
7.Sterilization MethodGas PlasmaGammaGas Plasma
Assessment: Subject is similar to primary predicate and identical to additional
predicate. Supporting process validation demonstrates that there are no new issues
raised by the differences in methodology. The sterilization methods are therefore
equivalent.
Performance AnalysisMechanical testing of the subject devices to demonstrate equivalence
in function and safety for the intended use of the FITBONE® Transport
and Lengthening nails and trial nails in respect to its additional
predicate FITBONE® TAA (K203399) have been performed for the
following functional attributes and are included in section "Bench
Testing" of this eSTAR application form, as below:
Implantable rod: Static 4-point bending test (with Subject
FITBONE® Transport and Lengthening nail) performed according
to ASTM F1264-16 - Standard Specification and Test Methods for
Intramedullary Fixation Devices, Implantable rod: Fatigue 4-point bending test (with Subject
FITBONE® Transport and Lengthening nail) performed according
to ASTM F1264-16 - Standard Specification and Test Methods for
Intramedullary Fixation Devices. The Fatigue limit calculation are,
instead, performed according to ISO 12107:2012 - Metallic
materials — Fatigue testing — Statistical planning and analysis of
data, Implantable rod: Torsional test (with Subject FITBONE® Transport
and Lengthening nail) performed according to ASTM F1264-16 -
Standard Specification and Test Methods for Intramedullary
Fixation Devices, Implantable rod: Absorbed current by the nail's motor during usage
when different forces are applied (with Subject FITBONE®
Transport and Lengthening nail). The test performed does not refer
to any standard since it is designed for this specific component.
The test requires the measurement of the current consumption of
the motor while running to obtain a displacement when different
forces are applied to the actuator.
ConclusionBased upon equivalences in: intended use, patient population, site of
application, conditions of use, operating principles, and the non-clinical
performance data, the subject FITBONE® Transport and Lengthening
System have been shown to be substantially equivalent to the legally
marketed predicate device.

() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy ↑ 2 +39 045 6719380   冊 orthofix.com

DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)

SEDE LEGAL: VA VITOR RIANI 6 L. P. P.VA 0897660150 CE VA NUMER TOSP660150 Registo Millero97680010 R.E. M 125769 Cap. So. E.o. 1.56.000 in. ves.
SED 0.00 in. VA DELL MADON,

6

Image /page/6/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. A registered trademark symbol is located to the right of the "X" in "ORTHOFIX".

() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy ↑ 29 045 6719380 曲 orthofix.com

DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)

SED LEGAL: VA VITOR PIANI 6 L D. A. A. S. P. A 0897660150 CE VAT NUMB: RT097660150 R.E., Mi 125769 Cap. So. E.E. 1.560.00 in. ves.
SED. SECONDRIA: VA DELL MAZON, 9 37012 BUS