(29 days)
Not Found
No
The summary describes a mechanical bone screw system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as being "intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," which clearly indicates a therapeutic purpose.
No
The device is described as a "SI Joint Fusion System" consisting of "bone screws" for "sacroiliac joint fusion". This is a therapeutic device intended for treatment, not diagnosis.
No
The device description explicitly states it consists of bone screws made from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a system of bone screws intended for surgical implantation to fuse the sacroiliac joint. This is a surgical implant, not a test performed on a sample outside the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the PathLoc SI Joint Fusion System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. This submission adds an additional screw option to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
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)
An engineering analysis was utilized to determine that the additional components do not introduce a new worst case for device performance. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing.
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
February 23, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
L&K Biomed Co., Ltd. Kihyang Kim #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu Yongin-si. Gyeonggi 17015 South Korea
Re: K240201
Trade/Device Name: PathLoc SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 20, 2024 Received: January 25, 2024
Dear Kihyang Kim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Image /page/1/Picture/7 description: The image contains the text "n O'neill -S FDA". The text "n O'neill -S" is on the left side of the image, and the letters "FDA" are on the right side of the image. The letters "FDA" are large and light blue.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
PathLoc SI Joint Fusion System
Indications for Use (Describe)
The PathLoc SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Type of Use (Select one or both, as applicable)
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."
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510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
1. MANUFACTURER
| Submitter's Name: | L&K Biomed Co., Ltd. |
|---|---|
| Submitter's Address: | #101, 201, 202 16-25, Dongbaekjungang-ro 16 beon-gil |
| Giheung-gu, Yongin-si, Gyeonggi-do, 17015, South Korea. | |
| Submitter's Telephone: | 82-2-6717-1983 |
| Contact Person: | Kihyang Kim |
| khkim@lnkbiomed.com | |
| Prepared Date: | Jan 24, 2024 |
2. DEVICE IDENTIFICATION
| Device Trade Name | PathLoc SI Joint Fusion System |
|---|---|
| Common/Usual Name | Sacroiliac Joint Fixation, Bone Screw |
| Regulation Class /Number | Class II / 21 CFR 888.3040 |
| Regulation Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | OUR |
| Classification Panel | Spinal Devices (DHT6B) |
3. PREDICATE OR LEGALLY MARKETED DEVICES WHICH ARE SUBSTANTIALLY EQUIVALENT.
| Subject Device Name | 510K NO. | Trade or Proprietary or Model Name | Predicate Type |
|---|---|---|---|
| PathLoc SI Joint | |||
| Fusion System | K231841 | PathLoc SI Joint Fusion System | Primary |
The design features, indications for use, material and manufacturing process for the subject devices are substantially equivalent to the predicate devices.
4. MATERIALS
| PATHLOC SI Joint Fusion System | |
|---|---|
| CT1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | Complete of the comments of the comments of the comments of the |
The additional components material is the same material used in the predicate devices (K231841).
DESCRIPTION OF THE DEVICE 5.
The PATHLOC SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The devices are manufactured from titanium alloy per ASTM F136. This submission adds an additional screw option to the system.
6. INDICATION FOR USE
The PATHLOC SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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7. PERFORMANCE TESTING
PATHLOC SI Joint Fusion System
An engineering analysis was utilized to determine that the additional components do not introduce a new worst case for device performance. None of the additional components is the worst case of the PathLoc SI Joint Fusion System and the additional components to be added through this submission do not require additional mechanical testing.
SUMMARY OF TECHNOLOGY CHARACTERISTICS 8.
Subject devices are identical to the predicate devices in material, Indication for use, manufacturing process, and surgical approach.
9. SUBSTANTIAL EQUIVALENCE
Subject devices are shown to be substantially equivalent to the predicate devices in indications for use, design, function and materials used.
10. CONCLUSION
The overall technology characteristics lead to the conclusion that the PathLoc SI Joint Fusion System is substantially equivalent to the predicate devices (K231841).