OIC External Fixation System

K183682 · Orthopaedic Implant Company · KTT · Apr 8, 2019 · Orthopedic

Device Facts

• Record ID: K183682
• Device Name: OIC External Fixation System
• Applicant: Orthopaedic Implant Company
• Product Code: KTT · Orthopedic
• Decision Date: Apr 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Device Story

External fixation system for stabilization of bone fractures; consists of carbon fiber composite bars, titanium/aluminum clamps, aluminum posts, and stainless steel pins. Pins implanted into bone; connected via clamps, rods, and posts to form rigid construct holding bone fragments in place. Used by surgeons in clinical settings for fracture management. Benefits include rigid stabilization of unstable or infected fracture sites where internal fixation may be contraindicated.

Clinical Evidence

Bench testing only. MRI compatibility testing was performed to evaluate the system's characteristics in an MRI environment.

Technological Characteristics

Components: carbon fiber composite bars (11mm diameter), titanium/aluminum clamps, aluminum posts, stainless steel pins (4mm/5mm). Mechanical fixation principle. Non-powered. Manual assembly. MRI compatible.

Indications for Use

Indicated for adult and pediatric patients requiring provisional fixation of open/unstable fractures of lower/upper extremities and pelvis, or temporary fixation of periarticular/intra-articular fractures, including cases with soft tissue injury or infected fracture sites.

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

• OIC External Fixation System (K171211)
• Synthes Large External Fixation MR Conditional (K082650)

Submission Summary (Full Text)

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

# Indications for Use

510(k) Number (if known) K183682

Device Name

OIC External Fixation System

Indications for Use (Describe)

The OIC External Fixation system is intended to be used in adult and pediatic patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of periarticular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

| 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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April 8, 2019

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

Re: K183682

Trade/Device Name: OIC External 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: KTT Dated: March 11, 2019 Received: March 12, 2019

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Summary

Prepared 4/4/2019

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 External Fixation System Common Name: External fixation components Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification: Class II, 21 CFR 888.3030 Panel: Orthopedic Product Code: KTT

Indications for Use:

The OIC External Fixation system is intended to be used in adult and pediatric patients for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

Device Description:

The device is used for the external stabilization of bone fractures. It consists of:

Carbon fiber composite bars, 11mm diameter, 100mm to 650mm lengths

Titanium and aluminum combination clamp, 5 & 8 hole pin clamp

Aluminum straight and angled posts

Stainless steel 4mm and 5mm pins, blunt tip and threaded 150mm lengths, 15mm through 120mm thread lengths.

Stainless steel 5mm transfixing pin, 300mm length

Stainless steel instruments for implantation

The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

Comparison of Technological Characteristics (Substantial Equivalence):

Predicate devices: K171211 OIC External Fixation System, K082650 Synthes Large External Fixation MR Conditional The OIC External Fixation System has the following similarities to those which previously received 510(k) concurrence:

· has the same indicated use,

- · uses the same operating principle,
- · incorporates the same design, and
- · incorporates the same or similar materials

### Performance Testing:

Magnetic resonance imaging (MRI) compatibility testing was performed on the OIC External Fixation System. Testing shows that the system has acceptable MRI characteristics for the intended uses.

Conclusion:

The OIC External Fixation System described in this submission is, in our opinion, substantially equivalent to the predicate devices.