TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities. The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.

Device Description

The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.
The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.
The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).
The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.
The positioning of the half pins is driven by a template.
During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.
The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.

AI/ML Overview

The Orthofix TrueLok™ Elevate is an external fixation component system intended for the treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities in adult and pediatric patients (greater than 2 through 21 years of age).

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific pass/fail acceptance criteria values for the mechanical tests conducted. Instead, it describes comparative testing against predicate or reference devices to demonstrate similarity in performance. The assessment for each technological characteristic indicates that "no different questions have been raised" or that the subject device's indications fall within the predicate's, suggesting that the goal was to demonstrate equivalence rather than meeting pre-defined numerical thresholds for acceptance.

Test Description	Reported Device Performance
External Frame:
Static axial stiffness test (according to ASTM F1541-17 Annex 7)	Performed for subject TrueLok Elevate external fixator. Performance was compared with reference device True/Lok Monolateral/Bilateral Fixator (K941048). The implicit acceptance criterion is that its stiffness is comparable or superior to the reference device, ensuring similar mechanical behavior.
Slipping torque on connectors test (according to ASTM F1541-17 Annex 2)	Performed for subject TrueLok Elevate external fixator. Performance was compared with reference device True/Lok Monolateral/Bilateral Fixator (K941048). The implicit acceptance criterion is that its slipping torque is comparable or superior to the reference device, ensuring secure connection and stability.
Half Pins:
Static 4-point bending evaluation	Performed for subject half pins of TrueLok Elevate. Performance was compared to the predicate device Orthofix TrueLok Hexapod System (K170650). The implicit acceptance criterion is that its bending strength is comparable or superior to the predicate device, ensuring similar structural integrity.
Torsional strength evaluation	Performed for subject half pins of TrueLok Elevate. Performance was compared to the predicate device TrueLok Hexapod System (K170650). The implicit acceptance criterion is that its torsional strength is comparable or superior to the predicate device, ensuring similar resistance to twisting forces.
Overall Assessment:	The conclusions state: "Based upon substantial equivalences in: intended use, patient population, site of application, conditions of use, operating principles, and the non-clinical performance data, the subject TrueLok™ Elevate has been shown to be substantially equivalent to the legally marketed predicate device (K170650)." This indicates the device met the implicit acceptance criterion of performing comparably to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the mechanical tests (e.g., number of external fixators or half pins tested).
The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective, as these were bench tests performed on devices rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to this type of submission. The ground truth for mechanical performance is established through standardized testing protocols (e.g., ASTM standards) and comparisons to previously cleared predicate devices, not through expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this type of submission as the mechanical tests are objectively measured, not subject to subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not performed. This type of study is typically relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. The TrueLok™ Elevate is a physical external fixation system.

6. Standalone (Algorithm Only) Performance Study

A standalone study was not performed, as the device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth used for demonstrating performance was based on objective mechanical measurements conducted in accordance with recognized industry standards (e.g., ASTM F1541-17) and comparisons to the established performance characteristics of legally marketed predicate devices. The "truth" is that the new device's mechanical properties fall within acceptable limits or are comparable to those of the predicate, as determined by these tests.

8. Sample Size for the Training Set

This information is not applicable. The TrueLok™ Elevate is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

December 3, 2024

Orthofix S.r.l. Elvira Taccarelli Regulatory Affairs Manager Via delle Nazioni, 9 Bussolengo, IT 37012 Italy

Re: K242861

Trade/Device Name: TrueLok™ Elevate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT Dated: September 20, 2024 Received: September 20, 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.

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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).

Your device is also subject to, among other requirements, the Quality System (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Lixin Liu -S

Lixin Liu, Ph.D 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

Submission Number (if known)

K242861

Device Name

patients.

TrueLok Elevate

Indications for Use (Describe)

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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ORTHOFIX®

510(K) SUMMARY

ORTHOFIX SRL TRUELOK™ ELEVATE

Submitter information

Company Name:	Orthofix S.r.l.
Address	Via Delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+39 045 6719000
Fax	+39 045 6719380
Contact Person	Elvira Taccarelli

Contact Person	Elvira TaccarelliRegulatory Affairs Manager
Address	Via Delle Nazioni, 937012 Bussolengo (VR) - Italy
Telephone	+39 045 6719000
Fax	+39 045 6719380
Email address	elvirataccarelli@orthofix.it
Date prepared	November 27th, 2024

Trade Name, Classification

Trade Name:	TrueLok™ Elevate
Classification Regulation Nr:	21 CFR 888.3030
Regulation name:	Single/multiple component metallic bone fixation appliances and accessories
Review Panel:	Orthopedic
Product Code:	KTT
Device Class:	Class II
Device Classification Name:	Appliance, fixation, nail/blade/plate combination, multiple component

Predicate and additional reference devices

Predicate Device	510(k) Number	Manufacturer
Orthofix TrueLok Hexapod System (TL-HEX) V.2.0	K170650	Orthofix S.r.l.
Reference Devices	510(k) Number	Manufacturer
TrueLok Monolateral/Bilateral Fixator	K941048	Orthofix S.r.l.
Orthofix Modulsystem	K955848	Orthofix S.r.l.
Orthofix Femoral Nailing System	K973944	Orthofix S.r.l.
Orthofix External Fixation Screw (Pin)with Hydroxyapatite Coating	K974186	Orthofix S.r.l.
Orthofix Titanium Nailing Systems	K053261	Orthofix S.r.l.
Orthofix Galaxy Fixation System	K113770	Orthofix S.r.l.
Orthofix Ankle Hindfoot Nailing System	K141571	Orthofix S.r.l.
Orthofix Chimaera Hip Fracture	K161466	Orthofix S.r.l.

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Image /page/5/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 small "R" in a circle is present to the right of the word, indicating a registered trademark.

Device Description	The subject TrueLok Elevate is an external fixation component system (including its accessories) to be used with the Orthofix TrueLok family, for which Orthofix identified as a predicate device TrueLok Hexapod System (TL-HEX) V2.0 (K170650). The subject device consists in a further series of elements for external fixation added to the Orthofix TrueLok family with the aim of supporting the Orthofix TrueLok external fixator systems family falling within the indications for use of the more extensive, cleared indications for use of the chosen predicate device, for the specific use in bone transport treatment.The subject TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.The subject device is constituted by an external fixator and related accessories (half pins, k-wires, drill positioning guide, template and template inserts and convenience kits).The technique for the use of the subject device consists in fixing two half pins on the first cortical of the bone segment that the surgeon decided to transport, and two half pins on both cortexes of the bone.The positioning of the half pins is driven by a template.During the treatment, through the knob present on the device, the bone segment is gradually pulled outward by the patient/caregiver to laterally transport the bone segment.The subject device, as the predicate, will be implanted only by Healthcare Professionals (HCP), with full awareness of the appropriate orthopedic procedures (including application and removal), in the operating theatre only. The distraction of the limb will be activated in home by the patient/caregiver or in clinic theatre by the HCP. Treatment activation for pediatric patients in the home environment may require the assistance of a caregiver.
Indications for use	The TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.
Comparison ofTechnologicalCharacteristics withthe Predicate Device	The following table provides a comparison of technological characteristic of the subject and primary predicate device.Any differences have been demonstrated not to raise different questions of safety and effectiveness.
TechnologicalCharacteristic	Subject DeviceTrueLok Elevate	Predicate DeviceOrthofix TrueLok Hexapod System(TL-HEX) V.2.0 (K170650)
1. Intended use andindications forUse	The TrueLok Elevate is intended for treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.	The TL-HEX System is intended for limb lengthening by metaphyseal or epiphyseal distractions, fixation of open and closed fractures, treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.Indications, both for adults and all pediatric subgroups except newborns,
			post-traumatic joint contracturewhich has resulted in loss of range ofmotion- fractures and disease whichgenerally may result in jointcontractures or loss of range of motionand fracture requiring distraction- correction of bony or soft tissuedeformities- correction of bony or soft tissuedefects- joint arthrodesis- infected fractures or non-unions
		Assessment: The indications for use of the subject device fall within theindications for use of the predicate device.
2.	Target Population	Adult and pediatric (greater than 2through 21 years of age) patients.Assessment: The range of the target pediatric population for the subject device(greater than 2 through 21 years of age) falls within the pediatric patients rangeof the predicate device.	Adult and pediatric patients with theexception of newborns.
3.	Anatomical Sites	Long bonesAssessment: The subject device has the same anatomical application sites inrespect to the predicate device.	Long bones
4.	Intendedenvironment	Clinic and Home environmentAssessment: The subject device has the same intended environment of thepredicate device.	Clinic and Home environment
5.	External fixationframe Material	Bars (fixed and sliding): EN-AW 6082T6 conforming to UNI EN 573Assessment: Subject external fixation frame materials are similar topredicate device.Equivalent - no different questions have been raised.	rings: Aluminum (EN 754),struts: Aluminum alloy (EN754),stainless steel (ASTM A276), PEEK
6.	Half Pins Material	Stainless steel(AISI316LVM;ASTMF138/ISO5832-1)Assessment: Subject half pins material is identical to predicate.	Stainless steel(AISI316LVM;ASTMF138/ISO5832-1)
7.	Half Pins Range	length: 180 mm, diameter: 4.0 - 5.0 - 6.0mm (already cleared, not subject to thisapplication)length: 120 mm, diameter: 4.0 mmAssessment: The subject half pin length is shorter for the subject device than thepredicate device. This does not impact the safety and performance of the subjectdevice since longer length can be considered a worst case for mechanicalbehavior.Equivalent - no different questions have been raised.	length: 180 mmdiameter: 4.0 - 5.0 - 6.0 mm
8.	SterilizationMethod (Sterileitems)	Gamma radiationAssessment: The subject device has the same sterilization method as thepredicate device for components provided sterile	Gamma radiation

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ORTHOFIX®

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Image /page/7/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue circular shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A small "®" symbol is located to the right of the "X" in "ORTHOFIX".

Performance Data	The subject devices have similar configuration, materials, sizes, and design incomparison to the predicate Orthofix TrueLok Hexapod System (K170650) andthe additional reference device True/Lok Monolateral/Bilateral Fixator(K941048). The following mechanical evaluation was performed for the externalframe and the half pins:- Static axial stiffness test for subject TrueLok Elevate external fixatorperformed according to ASTM F1541-17 Annex 7 "Test Method for ExternalSkeletal Fixator/Constructs Subassemblies", in comparison with referencedevice True/Lok Monolateral/Bilateral Fixator (K941048).- Slipping torque on connectors test for subject TrueLok Elevate externalfixator performed according to ASTM F1541-17 Annex 2 "Test Method forExternal Skeletal Fixator Connectors", in comparison with reference deviceTrue/Lok Monolateral/Bilateral Fixator (K941048).- Static 4-point bending evaluation for subject half pins of TrueLok Elevate incomparison to the predicate device Orthofix TrueLok Hexapod System(K170650)- Torsional strength evaluation for subject half pins of TrueLok Elevate incomparison to the predicate device TrueLok Hexapod System(K170650)
Conclusions	Based upon substantial equivalences in: intended use, patient population, site ofapplication, conditions of use, operating principles, and the non-clinicalperformance data, the subject TrueLok™ Elevate has been shown to besubstantially equivalent to the legally marketed predicate device (K170650).

Performance Data

The subject devices have similar configuration, materials, sizes, and design incomparison to the predicate Orthofix TrueLok Hexapod System (K170650) andthe additional reference device True/Lok Monolateral/Bilateral Fixator(K941048). The following mechanical evaluation was performed for the externalframe and the half pins:- Static axial stiffness test for subject TrueLok Elevate external fixatorperformed according to ASTM F1541-17 Annex 7 "Test Method for ExternalSkeletal Fixator/Constructs Subassemblies", in comparison with referencedevice True/Lok Monolateral/Bilateral Fixator (K941048).- Slipping torque on connectors test for subject TrueLok Elevate externalfixator performed according to ASTM F1541-17 Annex 2 "Test Method forExternal Skeletal Fixator Connectors", in comparison with reference deviceTrue/Lok Monolateral/Bilateral Fixator (K941048).- Static 4-point bending evaluation for subject half pins of TrueLok Elevate incomparison to the predicate device Orthofix TrueLok Hexapod System(K170650)- Torsional strength evaluation for subject half pins of TrueLok Elevate incomparison to the predicate device TrueLok Hexapod System(K170650)

Conclusions

Based upon substantial equivalences in: intended use, patient population, site ofapplication, conditions of use, operating principles, and the non-clinicalperformance data, the subject TrueLok™ Elevate has been shown to besubstantially equivalent to the legally marketed predicate device (K170650).

Regulation Number and Section

§ 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.