(183 days)
Not Found
No
The description focuses on the mechanical components and materials of a surgical implant system, with no mention of AI/ML terms or functionalities.
No
The device is described as an implant system (screws and washer) used for surgical fixation of bones and joints, which is a therapeutic intervention, but the device itself is not a therapeutic device in the sense of delivering therapy (like a drug or radiation). It's a surgical implant.
No
The device is an implantable system for surgical fixation of bones and joints, not a diagnostic tool.
No
The device description clearly outlines 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Intended Use: The Intended Use of the IntraLock System clearly states it is for "reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot." This describes a surgical implant used directly on the patient's body.
- Device Description: The device description details physical implants (screws, washers) and surgical instruments, not reagents or equipment for analyzing biological samples.
The IntraLock System is a surgical implant used for orthopedic procedures, not for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
The IntraLock System is indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and joints of the foot. The two-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made of surgical grade stainless steel (per ASTM F899) with certain components made from aluminum alloy (Al6061).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones and joints of the foot, Talonavicular, Calcaneocuboid, and Metatarsocuneiform
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Both Static and Dynamic mechanical testing is presented to provided evidence that the IntraLock System is equivalent to that of the predicate.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
July 23, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fusion Orthopedics, LLC Whitney Rey Official Correspondent 4135 S. Powder Rd., Suite 110 Mesa. Arizona 85212
Re: K210159
Trade/Device Name: IntraLock System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 23, 2021 Received: June 24, 2021
Dear Whitney Rey:
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K210159
Device Name IntraLock System™
Indications for Use (Describe)
IntraLock is indicated for reduction and internal fixation of arthrodesis, osteotomies, intra-and extra-articular fractures, and nonunions of the small bones and joints of the three-part construct is specifically intended for use in Talonavicular, Calcaneocuboid, and Metatarsocuneiform Arthrodesis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: IntraLock System
| Date Prepared | 06/23/2021 |
|---|---|
| Submitted By | Fusion Orthopedics, LLC |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 | |
| Primary Contact | Whitney Rey |
| 4135 S. Power Rd., Suite 110 | |
| Mesa, AZ 85212 | |
| 800-403-6876 Tele | |
| e-mail: whitney@fusionorthopedics.com | |
| Trade Name | IntraLock System |
| Common Name | Screw, Fixation, Bone |
| Classification Name | Smooth & threaded metallic bone fixation fasteners |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Common Name | Screw, Fixation, Bone |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | Fusion Orthopedics' IntraLock Lapidus System (K182342) |
| Secondary Predicate | |
| Device | Fusion Orthopedics' FuzeFix Screw System (K170038) |
| Device Description | The IntraLock System is a three-part construct, consisting of a Locking Lag Screw of 2 |
| diameters and lengths ranging from 22mm to 55mm, a Setting Screw of 1 diameter with | |
| lengths ranging from 14mm to 24 mm, as well as a mating washer component consisting | |
| of 1 diameter and lengths ranging from 20mm to 28mm. The IntraLock Implants are | |
| constructed of titanium alloy (TI6AI4V). The specialized instruments are primarily made | |
| of surgical grade stainless steel (per ASTM F899) with certain components made from | |
| aluminum alloy (Al6061). | |
| Indications for Use | The IntraLock System is indicated for reduction and internal fixation of arthrodeses, |
| osteotomies, intra- and extra-articular fractures, and nonunions of the small bones and | |
| joints of 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 System and the predicate system are manufactured from the same |
| material and process, with similar sized screws and are substantially equivalent in terms | |
| of intended use, design, mechanical safety and performance. | |
| Non-clinical Test | |
| Summary | Both Static and Dynamic mechanical testing is presented to provided evidence that the |
| IntraLock System is equivalent to that of the predicate. | |
| The sterilization, cleaning, packaging, material, and manufacturing methods are identical | |
| to that of the predicate. | |
| Clinical Test | |
| Summary | No clinical studies were performed. |
| Conclusions: | Fusion Orthopedics LLC considers the IntraLock System to be equivalent to the |
| predicate device listed above. This conclusion is based upon the devices' similarities in | |
| principles of operation, technology, materials and indications for use. |
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