Valkyrie Thoracic Fixation System

K211695 · Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices · HRS · Jun 23, 2021 · Orthopedic

Device Facts

• Record ID: K211695
• Device Name: Valkyrie Thoracic Fixation System
• Applicant: Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices
• Product Code: HRS · Orthopedic
• Decision Date: Jun 23, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Valkyrie Thoracic Fixation System is intended for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

Device Story

Valkyrie Thoracic Fixation System provides mechanical stabilization for chest wall fractures; sternal reconstruction; trauma; planned osteotomies. System comprises PEEK-Optima (ASTM F2026) plates and Ti-6Al-4V (ASTM F136) screws (3.0mm/3.5mm diameters; 7-20mm lengths). Modification adds Caddy Guide instrument to assist surgical placement. Used in clinical/OR settings by surgeons. Device functions as bone fixation hardware; provides structural support to bone segments to facilitate healing. Benefits include rigid fixation in patients with varying bone quality.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation/reactivity), and ISO 10993-11 (acute systemic toxicity, material-mediated pyrogenicity).

Technological Characteristics

Plates: PEEK-Optima (ASTM F2026). Screws: Ti-6Al-4V (ASTM F136). Mechanical bone fixation system. Includes plates and screws of varying dimensions. Sterilization and packaging identical to predicate. No software or electronic components.

Indications for Use

Indicated for patients with normal or poor bone quality requiring stabilization and fixation of chest wall fractures, including sternal reconstructive procedures, trauma, or planned osteotomies.

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

• Valkyrie Thoracic Fixation System (K202889)

Submission Summary (Full Text)

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June 23, 2021

JM Longyear Manufacturing, LLC d/b/a Able Medical Devices Wade Depas Director, Quality & Product Development 512 4th Street Gwinn, Michigan 49841

Re: K211695

Trade/Device Name: Valkyrie Thoracic Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 2, 2021 Received: June 2, 2021

Dear Wade Depas:

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

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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 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,

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K211695

Device Name Valkyrie Thoracic Fixation System

Indications for Use (Describe)

The Valkyrie Thoracic Fixation System is intended for use in the stabilization of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies. The system is intended for use in patients with normal and/or poor bone quality.

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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# 510(k) SUMMARY

| Date Prepared: | June 2nd, 2021 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner /<br>Manufacturer: | JM Longyear Manufacturing, LLC d/b/a Able Medical Devices<br>512 4th Street, Gwinn, MI 49841<br>http://www.ablemedicaldevices.com<br>Establishment Registration #3014680795 |
| Contact Person: | Wade DePas Director, Quality & Product Development<br>Able Medical Devices<br>Phone: [phone]<br>Email: [e-mail] |
| Trade or Proprietary<br>Name: | Valkyrie™ Thoracic Fixation System |
| Common or Usual<br>Name: | Bone Plate |
| Classification: | Class II per 21 CFR §888.3030 (primary) and 21 CFR §888.3040 |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (primary); Screw, Fixation, Bone |
| Product Code: | HRS (primary), HWC |
| Classification Panel: | Panel Code 87: Orthopedics |
| Primary Predicate | K202889 Valkyrie Thoracic Fixation System |
| Description | The Valkyrie Thoracic Fixation System consists of a variety of screws<br>and plates intended for use in the stabilization and fixation of fractures<br>in the chest wall including sternal reconstructive surgical procedures,<br>trauma, or planned osteotomies. The system is intended for use in<br>patients with normal and/or poor bone quality.<br>To accommodate varying patient anatomy and surgeon preference, the<br>Valkyrie Thoracic Fixation System includes screws in 3.0mm and<br>3.5mm diameters and lengths from 7-20mm. The system also includes<br>various styles of plates. The Valkyrie Thoracic Fixation System plates<br>are made from PEEK-Optima™ per ASTM F2026, and the screws are<br>made from Ti-6Al-4V per ASTM F136. |
| Purpose of<br>Submission | Obtain clearance for the following modification to the predicate<br>K202889 Valkyrie Thoracic Fixation System: addition of Caddy Guide<br>Instrument (Device specific Instrument). |
| Indications for Use | This Valkyrie Thoracic Fixation System is intended for use in the<br>stabilization and fixation of fractures in the chest wall including sternal<br>reconstructive surgical procedures, trauma, or planned osteotomies. The<br>system is intended for use in patients with normal and/or poor bone<br>quality |

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| Summary of<br>Technological<br>Characteristics | The subject Valkyrie Thoracic Fixation System has similar<br>technological characteristics as the predicate K202889 devices cleared<br>for use in closure of the sternum. Similarities to the predicate device<br>include:<br>Identical indications for use Identical principles of operation and fundamental<br>technology: intended to stabilize and fixate fractures of the<br>anterior chest wall (e.g., sternal fixation) through the use of<br>plates and screws. Identical sterilization/cleaning Identical packaging/expiration dating Identical implant components The addition of the Caddy Guide instrument is supported by nonclinical testing listed below. |
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| Discussion of<br>Supporting Non-<br>Clinical Testing | The following nonclinical tests were submitted and relied upon in this<br>premarket notification submission for a determination of substantial<br>equivalence. Testing identified in Design Control Activities Summary<br>has all met acceptance criteria established by the associated recognized<br>standards:<br>Biocompatibility Cytotoxicity (ISO 10993-5:2009) Sensitization (ISO 10993-10:2010) Irritation or Intracutaneous Reactivity (ISO 10993-10:2010) Acute Systemic toxicity (ISO 10993-11:2017) Material-Mediated Pyrogenicity (ISO 10993-11:2017) |
| Conclusion | The results demonstrate that the acceptance criteria defined in the Design<br>Control Activities Summary were met. The Valkyrie Thoracic Fixation<br>System is shown to be substantially equivalent to the predicate system.<br>The subject device is as safe, as effective, as the predicate device. |