IntraLock Lapidus System

K182342 · Fusion Orthopedics, LLC · HWC · May 21, 2019 · Orthopedic

Device Facts

• Record ID: K182342
• Device Name: IntraLock Lapidus System
• Applicant: Fusion Orthopedics, LLC
• Product Code: HWC · Orthopedic
• Decision Date: May 21, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

Device Story

IntraLock Lapidus System is a two-part orthopedic bone fixation construct comprising a lag screw (22mm-50mm) and a mating washer (16mm-35mm). Used by surgeons in clinical settings for internal fixation of small bone fractures, arthrodeses, and osteotomies in the foot. The device provides mechanical stabilization of bone segments to facilitate healing. It is a purely mechanical implant system; no software or electronic components are involved.

Clinical Evidence

No clinical studies were performed. Evidence is based on bench testing, including static torsion, insertion torque, pull-out, and static/dynamic 4-point bending tests. Pyrogenicity was evaluated via LAL assay, confirming compliance with endotoxin limits.

Technological Characteristics

Construct consists of Ti-6Al-4V alloy (ASTM F136) lag screws and washers. Instruments are surgical grade stainless steel (ASTM F899). Additional materials include 6061 Aluminum (ASTM B209). Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of small bones and joints in the foot, specifically Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

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

• EXTREMITY MEDICAL Screw and Washer Implant System (K10700)
• FuzeFix Screw System (K170038)

Submission Summary (Full Text)

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May 21, 2019

Fusion Orthopedics, LLC Eli Jacobson Official Correspondent 4135 S. Power Rd., Suite 110 Mesa, Arizona 85212

Re: K182342

Trade/Device Name: IntraLock Lapidus System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 19, 2019 Received: April 22, 2019

Dear Eli Jacobson:

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

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

For comprehensive regulatory information about mediation-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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Stereotaxic, Trauma and Restorative 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) K182342

Device Name IntraLock Lapidus System

#### Indications for Use (Describe)

The IntraLock Lapidus System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints in the two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.

Type of Use (Select one or both, as applicable)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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| Date Prepared | April 16, 2019 |
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| Submitted By | Fusion Orthopedics, LLC<br>4135 S. Power Rd., Suite 110<br>Mesa, AZ 85212<br>800-403-6876 |
| Primary Contact | Eli Jacobson<br>4135 S. Power Rd., Suite 110<br>Mesa, AZ 85212<br>800-403-6876 Tele<br>e-mail: [e-mail] |
| Trade Name | IntraLock Lapidus System |
| Common Name | Bone Screws |
| Classification Name | Smooth & threaded metallic bone fixation fasteners |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary Predicate<br>Device | EXTREMITY MEDICAL Screw and Washer Implant System, Extremity Medical (K10700) |
| Secondary Predicate<br>Device | FuzeFix Screw System, Fusion Orthopedics (K170038) |
| Device Description | The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two<br>diameters and lengths ranging from 22mm to 50mm, as well as a mating washer<br>component consisting of one diameter and lengths ranging from 16mm to 35mm. The<br>IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized<br>instruments are made of surgical grade stainless steel (ASTM F899). |
| Indications for Use | The IntraLock Lapidus System is indicated for reduction and internal fixation of<br>arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small<br>bones and joints in the foot. The two-part construct is specifically intended for use in<br>Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis. |
| Materials | Ti-6Al-4V alloy (ASTM F136)<br>Stainless steel (ASTM F899)<br>6061 Aluminum (ASTM B209) |
| Substantial<br>Equivalence Claimed<br>to Predicate Devices | The Intralock Lapidus System is substantially equivalent to the predicate devices in<br>terms of intended use, design, materials used, mechanical safety and performances. |
| Non-clinical Test<br>Summary | The following analyses were conducted:<br>-Static torsion analysis.<br>-Insertion torque analysis.<br>-Pull-out analysis.<br>The following tests were conducted:<br>- Static 4-point bending test.<br>- Dynamic 4-point bending test.<br>- Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The<br>testing demonstrated that the subject device meets the recommended maximum<br>endotoxin level of 20 EU per device.<br>The results of these evaluations indicate that the IntraLock Lapidus System is equivalent<br>to predicate devices. |
| Clinical Test<br>Summary | No clinical studies were performed |
| Conclusions: | Fusion Orthopedics LLC considers the IntraLock Lapidus System to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the devices' similarities in<br>principles of operation, technology, materials and indications for use |

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