OIC Intramedullary Screw System

K223761 · Orthopaedic Implant Company · HWC · Feb 13, 2023 · Orthopedic

Device Facts

• Record ID: K223761
• Device Name: OIC Intramedullary Screw System
• Applicant: Orthopaedic Implant Company
• Product Code: HWC · Orthopedic
• Decision Date: Feb 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

Device Story

OIC Intramedullary Screw System consists of stainless steel screws and associated implantation instruments. Screws available in 3.6mm and 4.5mm diameters, lengths 25mm-80mm. Used by surgeons in clinical settings for bone fixation and arthrodesis. Device provides mechanical stabilization of bone fragments to facilitate healing. Implantation requires manual surgical technique. Provided non-sterile; requires facility sterilization prior to use.

Clinical Evidence

Bench testing only. Torsional, driving torque, and axial pullout strength testing performed per ASTM F543 (Annex A1, A2, A3) comparing subject device to Synthes predicate. Results confirmed acceptable mechanical characteristics.

Technological Characteristics

Materials: Wrought 18Cr-14Ni-2.5Mo stainless steel (ASTM F138, UNS S31673). Form factor: Cannulated screws (3.6mm/4.5mm diameter, 25-80mm length). Mechanical fixation principle. Non-sterile; requires facility sterilization.

Indications for Use

Indicated for fixation of intra-articular fractures, malunions, non-unions, or osteotomies of small bone fragments, and arthrodesis of small joints in adults.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Exsomed Corporation Innate Cannulated Screw System (K183603)
• Synthes USA Synthes 3.0mm Headless Compression Screws (K050636)
• Orthopaedic Implant Company OIC Cannulated Screw System (K113123)
• Orthopaedic Implant Company OIC Intramedullary Nail System (K181184)

Submission Summary (Full Text)

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February 13, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an eagle with outstretched wings, while the FDA part has the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Orthopaedic Implant Company Douglas Fulton Quality Assurance Manager 770 Smithridge Dr. #400 Reno, Nevada 89502

Re: K223761

Trade/Device Name: OIC Intramedullary Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 13, 2022 Received: December 15, 2022

Dear Douglas Fulton:

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

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali-S

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)

K223761

Device Name

OIC Intramedullary Screw System

### Indications for Use (Describe)

The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

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

Prepared 2/9/2023

Name and Address of Manufacturer: The Orthopaedic Implant Company (OIC) 770 Smithridge Drive. Suite 400 Reno, NV 89502

Contact: Douglas Fulton Quality Assurance Manager Telephone: [phone] Fax: [phone] Email: [e-mail]

Device Identification: Trade Name: OIC Intramedullary Screw System Common Name: Screw, Fixation, Bone Regulation Name, Number: Smooth or Threaded Metallic Bone Fixation Fastener, 21 CFR 888.3040 Classification: Class II Panel: Orthopedic Product Code: HWC

Indications for Use:

The OIC Intramedullary Screw System is indicated for the fixation of intra-articular fractures, malunions, non-unions or osteotomies of small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.

Device Description:

The OIC Intramedullary Screw System consists of stainless steel screws and instruments to facilitate implantation. The screws come in two diameters, 3.6mm and 4.5mm, and range in length from 25mm to 80mm. The system also includes the instruments used to implant the screws.

The OIC Intramedullary Screw System is provided non-sterilized by the medical facility prior to implantation.

The screws are manufactured material that conforms to:

ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

Comparison of Technological Characteristics (Substantial Equivalence):

The primary predicate device is: Exsomed Corporation K183603 Innate Cannulated Screw System Additional predicate devices: Synthes USA K050636 Synthes 3.0mm Headless Compression Screws Orthopaedic Implant Company K113123 OIC Cannulated Screw System Orthopaedic Implant Company K181184 OIC Intramedullary Nail System

The OIC Intramedullary Screw System has the following similarities to those which previously received 510(k) concurrence:

· has the same indicated use,

· uses the same operating principle,

· incorporates a very similar design, and

· incorporates the same materials

Performance Testing:

Torsional, driving torque and axial pullout strength testing were performed on the OIC and Synthes screws per ASTM F543, "Standard Specification and Test Metallic Medical Bone Screw" annex A1, A2 and A3. The screws were found to have acceptable mechanical characteristics for the intended uses.

Conclusion:

The OIC Intramedullary Screw System described in this substantially equivalent to the predicate devices.