EVOS Cabling System

K201497 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · JDQ · Oct 28, 2020 · Orthopedic

Device Facts

• Record ID: K201497
• Device Name: EVOS Cabling System
• Applicant: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
• Product Code: JDQ · Orthopedic
• Decision Date: Oct 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

Device Story

EVOS Cabling System is a bone fixation cerclage device used in orthopedic trauma and reconstructive surgeries to reduce and stabilize fractures or osteotomies. The system consists of a sterile, stainless-steel cable (ASTM F1314) and a stainless-steel crimp (ASTM F138), accompanied by non-sterile, reusable instruments. During surgery, the surgeon passes the cable around the bone, tensions it, and secures it using the crimp mechanism to provide supplementary fracture fixation. The device is intended for use in clinical settings by orthopedic surgeons. It is MR Conditional. The system provides mechanical stabilization to bone segments, facilitating healing and potentially reducing the need for more invasive fixation methods.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including static and dynamic tensile testing of construct strength, MR safety evaluation (ASTM F2052-15, F2213-17, F2182-11a, F2119-07), sterilization validation, and biological safety evaluation (ISO 10993-1). Pyrogenicity was assessed via LAL assay with an endotoxin limit of 20 EU per device.

Technological Characteristics

Materials: Stainless steel cable (ASTM F1314) and crimp (ASTM F138). Design: Multistrand, bundled cable with crimp-based locking mechanism. Sterilization: Gamma radiation for implants; validated sterilization for reusable instruments. Packaging: Double sterile barrier. MR status: MR Conditional.

Indications for Use

Indicated for patients requiring orthopedic repair procedures including patellar, femoral, tibial, olecranon, and ankle fractures; general cerclage; trochanteric reattachment; prophylactic banding; and fixation of spiral fractures with intramedullary nails or screws.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Orthopedic Cabling System (K031162)
• SDB Cerclage System (K992616)

Submission Summary (Full Text)

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Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) % Jaclyn Holli Regulatory Affairs Specialist RTI Surgical, Inc 375 River Park Circle Marquette, Michigan 49855

Re: K201497

Trade/Device Name: EVOS Cabling System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: October 9, 2020 Received: October 13, 2020

### Dear Jaclyn Holli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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

October 28, 2020

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For; Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K201497

Device Name EVOS Cabling System

Indications for Use (Describe)

The EVOS Cabling System is intended to be used in general orthopaedic repair procedures including patellar fractures, general cerclage, trochanteric reattachment, femoral and tibial fractures, prophylactic banding, olecranon fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nail and screw fixation techniques.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | |

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary per 21 CFR 807.92 EVOS Cabling System

| Date Prepared | October 27, 2020 |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner/<br>Manufacturer | Pioneer Surgical Technology, Inc.<br>(DBA RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855, USA<br>Registration #1833824 |
| Submitter/Contact<br>Person | Jaclyn Holli – Regulatory Affairs Specialist<br>RTI Surgical, Inc.<br>Phone: [phone]<br>Email: [e-mail] |
| Trade Name of<br>Device | EVOS Cabling System |
| Common Name | Cerclage, Fixation |
| Classification<br>Name | Bone Fixation Cerclage |
| Classification | Class II per 21 CFR 888.3010<br>Product code JDQ |
| Panel | Orthopedic Device Panel |
| Predicate | Primary Predicate: Orthopedic Cabling System (K031162)<br>Additional Predicate: SDB Cerclage System (K992616) |
| Description of<br>Device | The EVOS Cabling System is used in orthopedic trauma and<br>reconstructive surgeries to reduce and stabilize fractures and<br>osteotomies. The EVOS Cabling System may be used for<br>supplementary fracture fixation when used with bone plates or<br>screws.<br>The EVOS Cabling System includes a sterile, stainless-steel cable<br>implant (ASTM F1314) packaged together with a stainless-steel<br>crimp (ASTM F138). Non-sterile, reusable instruments are also<br>provided to facilitate proper implantation of the cable-crimp implant. |
| Purpose of<br>Submission | To obtain FDA Clearance of the EVOS Cabling System. There are<br>no prior submissions for the subject system. |
| Indications for<br>Use | The EVOS Cabling System is intended to be used in general<br>orthopaedic repair procedures including patellar fractures, general<br>cerclage, trochanteric reattachment, femoral and tibial fractures,<br>prophylactic banding, olecranon fractures, ankle fractures, fixation<br>of spiral fractures in conjunction with intramedullary nail and screw<br>fixation techniques. |
| Summary of<br>Technological<br>Characteristics | The subject EVOS Cabling System has the same intended use and<br>technological characteristics as the predicates and the following<br>similarities: |
| | Fundamental technology and intended uses: orthopedic<br>cable cerclage to reduce and stabilize fractures for bone<br>fixation Overall design: multistrand, bundled cable with a<br>mechanism to resist tension and lock the construct (crimp<br>or clamp cerclage) Principles of operation (cable passage around bone,<br>cerclage tensioning and fixation) Materials: metallic, stainless steel alloys with well-<br>established manufacturing processes and biological safety Sterility: sterile via gamma radiation Single Use, Rx only Packaging: double sterile barrier packaging with a 5-year<br>shelf life Mechanical performance sufficient to perform its intended<br>use Same instrumentation types The minor differences in the design characteristics do not raise<br>different issues of safety or effectiveness as evidenced by the non-<br>clinical testing. The subject EVOS Cabling System will be labeled<br>as magnetic resonance (MR) conditional for which performance<br>testing has been submitted for support of this claim. There are no<br>other differences in technological characteristics between the<br>subject and predicate devices. |
| Discussion of<br>Supporting<br>Clinical Evidence<br>and Non-Clinical<br>Evidence | The following non-clinical evidence was submitted and relied upon<br>for a determination of substantial equivalence:<br>Mechanical performance: static and dynamic tensile testing<br>of the construct strength. MR Safety evaluation determined the devices are MR<br>Conditional via the following standard methods: ASTM F2052-15, Standard Test Method for<br>Measurement of Magnetically Induced Displacement<br>Force on Medical Devices in the Magnetic<br>Resonance Environment ASTM F2213-17, Standard Test Method for |
| | Medical Devices in the Magnetic Resonance<br>Environment ASTM F2182-11a, Standard Test Method for<br>Measurement of Radio Frequency Induced Heating<br>Near Passive Implants During Magnetic Resonance<br>Imaging ASTM F2119-07 (Reapproved 2013), Standard Test<br>Method for Evaluation of MR Image Artifacts from<br>Passive Implants Implant packaging and sterilization testing and evaluations,<br>relying on equivalency to predicate device design and<br>package configuration Instrument (and case components that keep the instruments<br>in place during transit and sterilization) sterilization testing<br>and evaluations, relying on subject validation testing ISO 10993-1 Biological safety evaluation, relying on<br>material and manufacturing process equivalency to<br>predicate devices. Pyrogenicity evaluation of the devices based on current<br>industry practice and FDA guidance for batch release<br>testing: endotoxin limit of 20 EU per device using the<br>Limulus amebocyte lysate (LAL) assay. There are no clinical tests relied on in this premarket notification<br>submission for a determination of substantial equivalence. |
| Conclusion | The evidence provided in this premarket notification submission<br>supports substantial equivalence of the subject EVOS Cabling<br>System to the predicate devices. |

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