(266 days)
K10700, K170038
Not Found
No
The summary describes a mechanical implant system and its associated instruments, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are based on mechanical testing.
Yes
The device is used for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions, which are therapeutic interventions.
No
Explanation: The device is described as an implantable system for reduction and internal fixation of bones and joints, which is a therapeutic function, not a diagnostic one. It is used to treat conditions, not to identify or characterize them.
No
The device description explicitly details physical components made of titanium alloy and stainless steel, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for fixing bones and joints in the foot. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a screw and washer system made of titanium alloy, designed for internal fixation. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties (torsion, insertion torque, pull-out, bending) and biocompatibility (pyrogenicity), which are relevant for surgical implants, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The IntraLock Lapidus System does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes
HWC
Device Description
The IntraLock Lapidus System is a two-part construct, consisting of a lag screw of two diameters and lengths ranging from 22mm to 50mm, as well as a mating washer component consisting of one diameter and lengths ranging from 16mm to 35mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are made of surgical grade stainless steel (ASTM F899).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and joints in the foot.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical Test Summary: The following analyses were conducted:
-Static torsion analysis.
-Insertion torque analysis.
-Pull-out analysis.
The following tests were conducted:
- Static 4-point bending test.
- Dynamic 4-point bending test.
- Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device.
The results of these evaluations indicate that the IntraLock Lapidus System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Key Metrics
Not Found
Predicate Device(s)
K10700, K170038
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| Date Prepared | April 16, 2019 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Eli Jacobson |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: eli@fusionorthopedics.com | |
| 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 | |
| Device | EXTREMITY MEDICAL Screw and Washer Implant System, Extremity Medical (K10700) |
| Secondary Predicate | |
| 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 |
| diameters and lengths ranging from 22mm to 50mm, as well as a mating washer | |
| component consisting of one diameter and lengths ranging from 16mm to 35mm. The | |
| IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized | |
| 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 |
| 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. | |
| Materials | Ti-6Al-4V alloy (ASTM F136) |
| Stainless steel (ASTM F899) | |
| 6061 Aluminum (ASTM B209) | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Intralock Lapidus System is substantially equivalent to the predicate devices in |
| terms of intended use, design, materials used, mechanical safety and performances. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| -Static torsion analysis. | |
| -Insertion torque analysis. | |
| -Pull-out analysis. | |
| The following tests were conducted: |
- Static 4-point bending test.
- Dynamic 4-point bending test.
- Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The
testing demonstrated that the subject device meets the recommended maximum
endotoxin level of 20 EU per device.
The results of these evaluations indicate that the IntraLock Lapidus System is equivalent
to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: | Fusion Orthopedics LLC considers the IntraLock Lapidus System to be equivalent to the
predicate devices listed above. This conclusion is based upon the devices' similarities in
principles of operation, technology, materials and indications for use |
4