(246 days)
The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.
The subject RODEO™ Telescopic Nail is a self-extending rod intended to provide bone fixation. The nail includes the telescopic rod, which consists of two parts (male and female) and bone anchors, which could be either a cap or an epiphyseal screw suitable to the anatomical application. The nail is provided in sterile and non-sterile version and is available in five diameters (3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm), identified by the outer diameter of the female part of the rod, and five lengths for each diameter model (from 100 mm up to 350 mm). Application and removal are performed with Orthofix general orthopedic instrumentation. The subject RODEO™ Telescopic Nail consists of three different components which are intended to be assembled to form the implant: Male component - A solid shaft with a built-in bone anchor for bone connection; the bone anchor has the same design as the cap (described below). Female component - A hollow shaft designed to host the male component. Bone anchors - Two options are available depending on the desired application: Cap - A self-locking screw to be connected with the female component at the opposite aspect of the extremity relative to the male component. Epiphyseal Pin - A threaded pin to be inserted into the distal extremity hole to hold the female component in position and prevent migration (see Figure 3) When the male and female components are assembled, the resulting implant is a telescopic rod. Male and female components are free to move both axially and rotationally; this allows the nail to extend axially as the patient growth occurs while allowing rotation around the bone anchors. The subject implants are made from AISI 316LVM stainless steel, conforming to ASTM F138 and ISO 5832-1.
This response describes the acceptance criteria and study proving the device meets criteria, derived from the provided text.
Based on the provided FDA 510(k) summary for the RODEO™ Telescopic Nail, the device's acceptance criteria and the study that proves it meets these criteria are primarily based on bench testing and demonstration of substantial equivalence to a predicate device, rather than clinical performance or AI algorithm validation. The documentation focuses on engineering and material properties.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the properties of the predicate device and relevant ASTM standards (ASTM F1264-16). The performance is shown by demonstrating that the subject device's mechanical properties are "equivalent or better" than the predicate device.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material: Conformance to Stainless Steel (316LVM, ISO 5832-1 and ASTM F138). | The subject device uses Stainless Steel (316LVM, ISO 5832-1 and ASTM F138), which is the same material as the predicate (316L, ASTM F138), with the subject device undergoing further purification (vacuum melt process). |
| General Design: Male component slides within mating female component as patient grows (in accordance with ASTM F1264-16). | The general design of the subject telescopic nail is in accordance with standard ASTM F1264-16 and is the same as the predicate device. |
| Bone Fixation: Similar to predicate (bi-cortical k-wire) and evaluated through bench testing. | The bone fixation method for the subject device (bi-cortical fixation with Orthofix pins) is similar to the predicate device (bi-cortical k-wire). Changes were evaluated through bench testing. Conclusion: Equivalent - no different questions of safety and effectiveness have been raised. |
| Nail Diameters: Similar range to predicate. | The subject device offers 3.5, 4.0, 4.5, 5.0 and 6.0 mm (5 diameters) which are similar to the predicate's 3.2, 4.0, 4.8, 5.6 and 6.4 mm (5 diameters). Potential performance differences have been demonstrated through bench testing to not raise significant new questions. Conclusion: Equivalent - no different questions of safety and effectiveness have been raised. |
| Nail Lengths: Similar range to predicate. | The subject device offers lengths up to 350mm, which are within the cleared range of the predicate device (up to 420mm). Conclusion: Equivalent - no different questions of safety and effectiveness have been raised. |
| Sterility Status: Same as predicate (Sterile and Non-sterile). | The subject device sterility status (Sterile and Non-sterile) is identical to the predicate device. Conclusion: Equivalent - no different questions of safety and effectiveness have been raised. |
| Sterilization Method: Same as predicate (Radiation). | The subject device sterilization method (Radiation) is identical to the predicate device. Conclusion: Equivalent - no different questions of safety and effectiveness have been raised. |
| Mechanical Performance (Male and Female Components): | |
| - Stiffness (4-point bending) | Evaluated through 4-point bending configuration. |
| - Yield Strength (4-point bending) | Evaluated through 4-point bending configuration. |
| - Fatigue (1,000,000 cycles) | Fatigue curve definition performed. |
| Mechanical Performance (End Caps): | |
| - Welding torque resistance | Assessed. |
| - Cap retention resistance (static test) | Assessed. |
| - Push-out testing (axial push-out from sawbone) | Conducted on both subject and predicate devices. |
| Mechanical Performance (Epiphysial Pin): | |
| - Torsion properties | Compared against a reference device (K132893). |
| - Driving torque | Compared against a reference device (K132893). |
| - Pullout properties | Compared against a reference device (K132893). |
| - Bending | Compared against a reference device (K132893). |
| Overall Performance: Equivalent or better than predicate. | "The performance of the nails were compared and the results are in line with the defined targets. Furthermore, additional static and dynamic testing was conducted on the worst case (smallest diameter) fully-assembled subject and predicate devices... This same testing was also conducted on the largest diameter fully-assembled subject and predicate devices. As is reflected by the testing, the subject device results were equivalent or better than those of the comparable predicate device." |
Study Details: Device Validation (Bench Testing)
-
Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of units, but testing was performed on "both male and female components of the subject and predicate devices" for mechanical testing, and "the worst case (smallest diameter) fully-assembled subject and predicate devices" as well as "the largest diameter fully-assembled subject and predicate devices" for additional static and dynamic testing. This implies multiple samples of each configuration were tested to generate data for stiffness, yield strength, fatigue, etc.
- Data Provenance: The data is from "bench testing" conducted by Orthofix SRL. It is not patient or clinical data, so country of origin isn't relevant in the same way, nor is it retrospective or prospective in the clinical sense. It's laboratory-generated data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a study involving human interpretation of data (e.g., medical images) to establish "ground truth." The ground truth for mechanical testing is established by the specified ASTM standards and the measured physical properties of the materials and devices.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human readers or subjective assessments requiring adjudication. The results are objective measurements from mechanical tests.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (intramedullary nail) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for the same reason as above. It is not an AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of submission is based on engineering specifications, material science standards (e.g., ASTM F138, ISO 5832-1), and mechanical testing standards (e.g., ASTM F1264-16). The performance of the subject device is measured against these established engineering benchmarks and compared directly to a legally marketed predicate device.
-
The sample size for the training set:
- Not applicable. This is not a machine learning model, so there is no training set.
-
How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a machine learning model.
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May 3, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. To the left of the FDA logo is the Department of Health & Human Services logo, which consists of a stylized image of people in profile.
Orthofix SRL % Mitchell Dhority Senior Director, Regulatory Orthofix US LLC 3451 Plano Parkway Lewisville, Texas 75056
Re: K232648
Trade/Device Name: RODEO Telescopic Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: April 5, 2024 Received: April 8, 2024
Dear Mitchell Dhority:
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).
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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.
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,
Image /page/1/Picture/6 description: The image shows a digital signature. The signature is by Farzana Sharmin -S. The date of the signature is 2024.05.03. The time of the signature is 12:06:35 -04'00'.
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
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Indications for Use
Submission Number (if known)
Device Name
RODEO Telescopic Nail
Indications for Use (Describe)
The RODEO Telescopic Nail is indicated for fractures, osteotomies, malunions and non-unions in femur and tibia in pediatric patients suffering from osteogenesis imperfecta.
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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Image /page/3/Picture/0 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 present to the right of the "X" in "ORTHOFIX", indicating a registered trademark.
510(K) SUMMARY
ORTHOFIX SRL RODEO™ Telescopic Nail
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 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 | 2024 April 5th |
Trade Name, Common Name, Classification
| Trade Name: | RODEO™ Telescopic Nail |
|---|---|
| Common Name: | Telescopic Intramedullary (IM) Nail |
| Classification Name: | Intramedullary fixation rod |
| Regulation Number: | 21 CFR 888.3020 |
| Product Code: | HSB |
| Classification: | Class II |
| Panel code: | Orthopedic |
Primary Predicate
| Primary Predicate | 510(k) Number | Manufacturer |
|---|---|---|
| Telescopic Intramedullary System | K211292 | Pega Medical Fassier Duval |
() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy \ \ +39 045 6719380 @ orthofix.com
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SEDE LEGALE: VA VITOR RSANT 6 L D SEDE SECONDARIA: VIA DELLE NAZIONI, 9 I 37012 BUSSOLENGO (VERONA) I ITALIA I Registro Imprese di Verona I R.E.A. VR 215209
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Image /page/4/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black capital letters on the right. The abstract shape is a stylized, curved design. The word "ORTHOFIX" is in a bold, sans-serif font, and there is a registered trademark symbol next to the "X".
Reference devices
| Reference Devices | 510(k) Number | Manufacturer |
|---|---|---|
| ORTHOFIX MODULSYSTEM | K955848 | Orthofix s.r.l. |
| EDGE ORTHOPAEDICS BITECOMPRESSION SCREW | K132893 | Orthofix s.r.l. |
| JPS JuniOrtho Plating System | K200246 | Orthofix s.r.l. |
| Device description | The subject RODEOT™ Telescopic Nail is a self-extending rod intendedto provide bone fixation.The nail includes the telescopic rod, which consists of two parts (maleand female) and bone anchors, which could be either a cap or anepiphyseal screw suitable to the anatomical application. The nail isprovided in sterile and non-sterile version and is available in fivediameters (3.5mm, 4.0mm, 4.5mm, 5.0mm and 6.0mm), identified bythe outer diameter of the female part of the rod, and five lengths foreach diameter model (from 100 mm up to 350 mm).Application and removal are performed with Orthofix generalorthopedic instrumentation.The subject RODEOTM Telescopic Nail consists of three differentcomponents which are intended to be assembled to form the implant:Male component - A solid shaft with a built-in bone anchor forbone connection; the bone anchor has the same design as thecap (described below).Female component - A hollow shaft designed to host the malecomponent.Bone anchors - Two options are available depending on thedesired application:Cap - A self-locking screw to be connected with the femalecomponent at the opposite aspect of the extremity relativeto the male component.Epiphyseal Pin - A threaded pin to be inserted into thedistal extremity hole to hold the female component inposition and prevent migration (see Figure 3)When the male and female components are assembled, the resultingimplant is a telescopic rod. Male and female components are free tomove both axially and rotationally; this allows the nail to extend axiallyas the patient growth occurs while allowing rotation around the boneanchors.The subject implants are made from AISI 316LVM stainless steel,conforming to ASTM F138 and ISO 5832-1. |
|---|---|
| Indications for use | The RODEO Telescopic Nail is indicated for fractures, osteotomies,malunions and non-unions in femur and tibia in pediatric patientssuffering from osteogenesis imperfecta. |
() Orthofix Srl | Via delle Nazioni, 9 | 37012 Bussolengo (VR) Italy \ \ +39 045 6719380 冊 orthofix.com
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
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Image /page/5/Picture/0 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 present to the right of the word "ORTHOFIX".
| TechnologicalCharacteristicsThe following table provides a comparison and assessment offundamental scientific principles and technological characteristics ofthe subject and the primary predicate devices. Any differences havebeen demonstrated to not raise different questions of safety orperformance by virtue of objective evidence (e.g., bench testing, etc.).Therefore, the technological characteristics of the subject RODEOTelescopic Nail are equivalent to the primary predicate PegaMedical Fassier Duval Telescopic Intramedullary System (K211292). | |||
|---|---|---|---|
| TechnologicalCharacteristics | Subject DeviceRODEO Telescopic Nail | Primary Predicate DevicePega Medical Fassier DuvalTelescopic IntramedullarySystem | |
| 1. | Indications for use | This implant is indicated forfractures, osteotomies,malunions and non-unions infemur and tibia in pediatricpatients suffering fromosteogenesis imperfecta | This implant is indicated as atemporary implant to aid inthe healing of long diaphysisfractures, osteotomies,malunions and non-unionsand to prevent furtherfractures in femur, tibia andhumerus in pediatric patientssuffering from OsteogenesisImperfecta without disruptingthe bone growth plate. It canbe used in procedures suchas bone lengthening/shortening concomitantly with externalfixators in pediatric or smallstature patients with limblength discrepancy |
| Assessment: The subject indications are included in the primary predicate indicationsfor use. The difference in the anatomical site application, more extensive for thepredicate device, do not constitute a new intended use. Equivalent - no differentquestions of safety and effectiveness have been raised. | |||
| 2. | Anatomical Sites | Long bones(Femur, tibia) | Long bones(Femur, tibia, humerus) |
| Assessment: The anatomical sites for use for the subject device are within theanatomical sites cleared for the predicate device (femur, tibia). Equivalent - nodifferent questions of safety and effectiveness have been raised. | |||
| 3. | Nail Material | Stainless Steel(316LVM, ISO 5832-1 andASTM F 138) | Stainless Steel(316L, ASTM F138) |
| Assessment: The material for the subject implants and predicate implants is the same(stainless steel), conforming to the same standard. 316LVM for the subject deviceundergoes a vacuum melt process for further purification. Equivalent - no differentquestions of safety and effectiveness have been raised. | |||
| 4. | General Design | Male component slides withinmating female component aspatient grows | Male component slides withinmating female component aspatient grows |
| Assessment: The general design of the subject telescopic nail is in accordance withstandard ASTM F1264-16, and is the same of the predicate device. Equivalent - nodifferent questions of safety and effectiveness have been raised. | |||
| 5. | Bone Fixation | Proximal and distal screw-likeanchor fixation features onmale/female components;fixation with bi-corticalthreaded cross pin to reducepotential nail migration | Proximal and distal screw-likeanchor fixation features onmale/female components;distal fixation option with bi-cortical k-wire to reducepotential nail migration |
| Assessment: The bone fixation method for the subject device (bi-cortical fixation withOrthofix pins) is similar to the predicate device (bi-cortical k-wire). The change infixation features have been evaluated through bench testing. Equivalent - no differentquestions of safety and effectiveness have been raised. | |||
| 6. | Nail Diameters | 3.5, 4.0, 4.5, 5.0 and 6.0 mm (5diameters) | 3.2, 4.0, 4.8, 5.6 and 6.4 mm(5 diameters) |
| Assessment: Size ranges of subject are similar to primary predicate device. Potentialperformance differences arising from variations in size offerings have beendemonstrated through bench testing to not raise significant new questions. The subjectdevice diameters are within the cleared range of the predicate device.Equivalent - no different questions of safety and effectiveness have been raised. | |||
| 7. | Nail Lengths | Up to 350mm | Up to 420 mm |
| Assessment: Nail lengths of subject are similar to primary predicate device. The subjectdevice nail lengths are within the cleared range of the predicate device.Equivalent - no different questions of safety and effectiveness have been raised. | |||
| 8. | Single Use | ||
| YesYesAssessment: Subject device single use status is identical to predicate device.Equivalent - no different questions of safety and effectiveness have been raised. | |||
| 9. | Sterility Status | ||
| Sterile and Non-sterileSterile and Non-sterileAssessment: Subject device sterility status is identical to predicate device.Equivalent - no different questions of safety and effectiveness have been raised. | |||
| 10. | Sterilization Method | Radiation | |
| RadiationAssessment: Subject device sterilization method is identical to predicate device.Equivalent - no different questions of safety and effectiveness have been raised. |
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
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Image /page/6/Picture/0 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, indicating a registered trademark, is located to the upper right of the "X" in "ORTHOFIX".
DIREZIONE E COORDINAMENTO: Orthofix Medical Inc. (Delaware)
SED LEGAL: VA VITOR PAAN I L L. P. P. (REZORE COORDINALITO, P. P. (R.) Mecial Inc. Patrial Mercial Mercer Mineral Mercer Mineral Merce (Meral P.E.A. M 12776) Cap Soc. Eu. 1.
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Image /page/7/Picture/1 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black letters on the right. The abstract shape is a curved shape that resembles a stylized "O". The word "ORTHOFIX" is in a bold, sans-serif font. There is a registered trademark symbol to the right of the word "ORTHOFIX".
| PerformanceAnalysis | Mechanical testing of the subject devices to demonstrate equivalencein function and safety for the intended use of the RODEO TelescopicNail in respect to its primary predicate Pega Medical Fassier DuvalTelescopic Intramedullary System (K211292) have been performed forthe following functional attributes and are included in section "BenchTesting" of this eSTAR application form, as below:Both male and female components of the subject and predicate devicesunderwent mechanical testing consisting of the following as perstandard ASTM F1264-16:- Stiffness evaluated through 4-point bending configuration- Yield Strength evaluated through 4-point bending configuration- Fatigue curve definition (1,000,000 cycles )End caps of the subject device were also tested by assessing weldingtorque resistance (the end cap is welded to the male component) andcap retention resistance (static test since the end cap is screwed ontothe female component). Push-out testing (ability of cap to grip boneunder axial push-out from a sawbone) was also conducted on bothsubject and predicate devices. Torsion properties, driving torque,pullout properties and bending of the subject epiphysial pin werecompared against a reference device (quide wire, 510(k) clearanceK132893) which fulfills all specification requirements called out in theoperative technique of the primary predicate device.The performance of the nails were compared and the results are in linewith the defined targets.Furthermore, additional static and dynamic testing was conducted onthe worst case (smallest diameter) fully-assembled subject andpredicate devices as per ASTM F1264-16. This same testing was alsoconducted on the largest diameter fully-assembled subject andpredicate devices.As is reflected by the testing, the subject device results were equivalentor better than those of the comparable predicate device. |
|---|---|
| Conclusion | Based upon equivalences in: intended use, operating principles, andthe non-clinical performance data, the subject RODEO Telescopic Nailhas been shown to be substantially equivalent to the legally marketedpredicate 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)
SED LEGAL: VA VITOR PAAN I L L. P. P. (REZORE COORDINALITO, P. P. (R.) Mecial Inc. Patrial Mercial Mercer Mineral Mercer Mineral Merce (Meral P.E.A. M 12776) Cap Soc. Eu. 1.
§ 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.