TrueLok Elevate

K242861 · Orthofix Srl · KTT · Dec 3, 2024 · Orthopedic

Device Facts

• Record ID: K242861
• Device Name: TrueLok Elevate
• Applicant: Orthofix Srl
• Product Code: KTT · Orthopedic
• Decision Date: Dec 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

TrueLok Elevate is an external fixation system for long bone treatment; used for non-union, pseudoarthrosis, and deformity correction. System includes external fixator, half pins, k-wires, drill guides, and templates. Surgeon fixes half pins to bone segments using template-guided positioning; patient or caregiver manually activates device via knob to perform lateral bone transport. Used in operating theater by surgeons; distraction performed in clinic or home environment. Provides mechanical stabilization and controlled bone segment movement to facilitate healing and correction.

Clinical Evidence

Bench testing only. Mechanical evaluation included static axial stiffness (ASTM F1541-17 Annex 7), connector slipping torque (ASTM F1541-17 Annex 2), static 4-point bending, and torsional strength testing of half pins. No clinical data provided.

Technological Characteristics

External fixation system. Frame bars: EN-AW 6082 T6 aluminum (UNI EN 573). Half pins: AISI 316LVM stainless steel (ASTM F138/ISO 5832-1). Mechanical fixation via pins and clamps. Sterilization: Gamma radiation. Non-powered, mechanical device.

Indications for Use

Indicated for adult and pediatric (2-21 years) patients requiring treatment of non-union or pseudoarthrosis of long bones and correction of bony or soft tissue defects or deformities.

Regulatory Classification

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.

Predicate Devices

• Orthofix TrueLok Hexapod System (TL-HEX) V.2.0 (K170650)

Reference Devices

• TrueLok Monolateral/Bilateral Fixator (K941048)
• Orthofix Modulsystem (K955848)
• Orthofix Femoral Nailing System (K973944)
• Orthofix External Fixation Screw (Pin) with Hydroxyapatite Coating (K974186)
• Orthofix Titanium Nailing Systems (K053261)
• Orthofix Galaxy Fixation System (K113770)
• Orthofix Ankle Hindfoot Nailing System (K141571)
• Orthofix Chimaera Hip Fracture (K161466)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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)

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, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | Elvira Taccarelli |

| Contact Person | Elvira Taccarelli<br>Regulatory Affairs Manager |
|----------------|-------------------------------------------------------|
| Address | Via Delle Nazioni, 9<br>37012 Bussolengo (VR) - Italy |
| Telephone | [phone] |
| Fax | [phone] |
| Email address | [e-mail] |
| 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)<br>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.<br>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.<br>The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients.<br>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).<br>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.<br>The positioning of the half pins is driven by a template.<br>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.<br>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.<br>The TrueLok Elevate is indicated for adult and pediatric (greater than 2 through 21 years of age) patients. | | |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Device | The following table provides a comparison of technological characteristic of the subject and primary predicate device.<br>Any differences have been demonstrated not to raise different questions of safety and effectiveness. | | |
| Technological<br>Characteristic | Subject Device<br>TrueLok Elevate | Predicate Device<br>Orthofix TrueLok Hexapod System<br>(TL-HEX) V.2.0 (K170650) | |
| 1. Intended use and<br>indications for<br>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.<br>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.<br>Indications, both for adults and all pediatric subgroups except newborns, | |
| | | | post-traumatic joint contracture<br>which has resulted in loss of range of<br>motion<br>- fractures and disease which<br>generally may result in joint<br>contractures or loss of range of motion<br>and fracture requiring distraction<br>- correction of bony or soft tissue<br>deformities<br>- correction of bony or soft tissue<br>defects<br>- joint arthrodesis<br>- infected fractures or non-unions |
| | | Assessment: The indications for use of the subject device fall within the<br>indications for use of the predicate device. | |
| 2. | Target Population | Adult and pediatric (greater than 2<br>through 21 years of age) patients.<br>Assessment: The range of the target pediatric population for the subject device<br>(greater than 2 through 21 years of age) falls within the pediatric patients range<br>of the predicate device. | Adult and pediatric patients with the<br>exception of newborns. |
| 3. | Anatomical Sites | Long bones<br>Assessment: The subject device has the same anatomical application sites in<br>respect to the predicate device. | Long bones |
| 4. | Intended<br>environment | Clinic and Home environment<br>Assessment: The subject device has the same intended environment of the<br>predicate device. | Clinic and Home environment |
| 5. | External fixation<br>frame Material | Bars (fixed and sliding): EN-AW 6082<br>T6 conforming to UNI EN 573<br>Assessment: Subject external fixation frame materials are similar to<br>predicate device.<br>Equivalent - no different questions have been raised. | rings: Aluminum (EN 754),<br>struts: Aluminum alloy (EN754),<br>stainless steel (ASTM A276), PEEK |
| 6. | Half Pins Material | Stainless steel<br>(AISI316LVM;ASTMF138/ISO5832-1)<br>Assessment: Subject half pins material is identical to predicate. | Stainless steel<br>(AISI316LVM;ASTMF138/ISO5832-1) |
| 7. | Half Pins Range | length: 180 mm, diameter: 4.0 - 5.0 - 6.0<br>mm (already cleared, not subject to this<br>application)<br>length: 120 mm, diameter: 4.0 mm<br>Assessment: The subject half pin length is shorter for the subject device than the<br>predicate device. This does not impact the safety and performance of the subject<br>device since longer length can be considered a worst case for mechanical<br>behavior.<br>Equivalent - no different questions have been raised. | length: 180 mm<br>diameter: 4.0 - 5.0 - 6.0 mm |
| 8. | Sterilization<br>Method (Sterile<br>items) | Gamma radiation<br>Assessment: The subject device has the same sterilization method as the<br>predicate 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 in<br>comparison to the predicate Orthofix TrueLok Hexapod System (K170650) and<br>the additional reference device True/Lok Monolateral/Bilateral Fixator<br>(K941048). The following mechanical evaluation was performed for the external<br>frame and the half pins:<br>- Static axial stiffness test for subject TrueLok Elevate external fixator<br>performed according to ASTM F1541-17 Annex 7 "Test Method for External<br>Skeletal Fixator/Constructs Subassemblies", in comparison with reference<br>device True/Lok Monolateral/Bilateral Fixator (K941048).<br>- Slipping torque on connectors test for subject TrueLok Elevate external<br>fixator performed according to ASTM F1541-17 Annex 2 "Test Method for<br>External Skeletal Fixator Connectors", in comparison with reference device<br>True/Lok Monolateral/Bilateral Fixator (K941048).<br>- Static 4-point bending evaluation for subject half pins of TrueLok Elevate in<br>comparison to the predicate device Orthofix TrueLok Hexapod System<br>(K170650)<br>- Torsional strength evaluation for subject half pins of TrueLok Elevate in<br>comparison to the predicate device TrueLok Hexapod System<br>(K170650) |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions | Based upon substantial equivalences in: intended use, patient population, site of<br>application, conditions of use, operating principles, and the non-clinical<br>performance data, the subject TrueLok™ Elevate has been shown to be<br>substantially equivalent to the legally marketed predicate device (K170650). |