(28 days)
Not Found
No
The summary describes a mechanical implant (bone screws) and its material properties and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "sacroiliac joint fusion system" intended for conditions like "sacroiliac joint disruptions and degenerative sacroiliitis," which clearly indicates a therapeutic purpose to treat or alleviate a medical condition.
No
The device is a fusion system intended for sacroiliac joint fusion, which is a treatment or surgical intervention, not a diagnostic process.
No
The device description explicitly states it consists of bone screws made of 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 medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The PathLoc-SI Joint Fusion System is a system of bone screws intended for surgical implantation to fuse the sacroiliac joint. It is a physical implant used directly within the body.
- Intended Use: The intended use is for sacroiliac joint fusion, a surgical procedure, not for analyzing biological samples.
The information provided clearly describes a surgical implant, not a device used for testing samples outside the body.
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
PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
- Arch Screw will be implanted in patient's bone then autograft will be inserted.
- Locking Screw can be used with washer or can be used on its own
- Self-tapping flute centers screw for easy insertion
Materials:
Arch Screw - Ti-6Al-4V ELI - ASTM F136
Locking Screw - Ti-6Al-4V ELI - ASTM F136
Washer - Ti-6Al-4V ELI - ASTM F136
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)
ASTM F543-13 Standard
- Torsional test
- Axial pullout test
- Driving torque test(Insertion/Removal)
ASTM F2193-14 Standard
- Static and fatigue bending strength of metallic spinal screw
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
Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
July 16, 2018
L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA
Re: K181600
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: June 15, 2018 Received: June 18, 2018
Dear Ms. Seo:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181600
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) | |
|---|---|
|X 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
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
-
- Submitter: L&K BIOMED Co., Ltd. #201, 202, 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone: 82-2-6717-1983 e-mail: kate.seo@lnkbiomed.com Contact Person: Jihyeon Seo Date prepared: June 15th, 2018
2. Device Identification
| Trade Name | PathLoc-SI Joint Fusion System |
|---|---|
| Common Name | Sacroiliac Joint Fixation / Sacroiliac Joint Fusion |
| Product Code | OUR |
| Regulatory Class | II |
| Classification Name | 21 CFR 888.3040 Smooth or threaded metallic bone |
| fixation fastener |
3. Purpose of 510(k)
The L&K BIOMED Co. Ltd. hereby submits this special 510(k): to register additional size and additional components of the PathLoc-SI Joint Fusion System
Predicate or legally marketed devices which are substantially equivalent 4.
- Primary Predicate(unmodified device): K153656 PathLoc-SI Joint Fusion System
Description of the Device 5.
PathLoc-SI Joint Fusion System consists of different diameter bone screws in various lengths and thread configurations to accommodate variations in patient anatomy. The material is Titanium alloy (Titanium-6Aluminum-4Vanadium ELI, per ASTM F136) approved for medical use.
- · Arch Screw will be implanted in patient's bone then autograft will be inserted.
- · Locking Screw can be used with washer or can be used on its own
- · Self-tapping flute centers screw for easy insertion
Materials:
| Product | Material | Standard |
|---|---|---|
| Arch Screw | Ti-6Al-4V ELI | ASTM F136 |
| Locking Screw | Ti-6Al-4V ELI | ASTM F136 |
| Washer | Ti-6Al-4V ELI | ASTM F136 |
4
Indication for Use 6.
The PathLoc-Sl Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Comparison of the technological characteristics of the subject and 7. predicate devices
The PathLoc-SI Joint Fusion System is considered substantially equivalent to the unmodified device (PathLoc-SI Joint Fusion System, K153656). They are similar in design and have the same material, and the same indications for use.
| | Subject Device | Predicate Device
(unmodified) |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | PathLoc-SI Joint Fusion
System | PathLoc-SI Joint Fusion
System |
| Manufacturer | L&K BIOMED Co.,Ltd. | L&K BIOMED Co.,Ltd. |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI |
| 510(K) No | | K153656 |
| Product Code | OUR | OUR |
| Regulation
No. | 21CFR888.3040 | 21CFR888.3040 |
| Class | Class II | Class II |
| Intended Use | The PathLoc-SI Joint Fusion
System is intended for
sacroiliac joint fusion for
conditions including sacroiliac
joint disruptions and
degenerative sacroililtis. | The PathLoc-SI Joint Fusion
System is intended for
sacroiliac joint fusion for
conditions including sacroiliac
joint disruptions and
degenerative sacroililtis. |
Performance Testing 8.
ASTM F543-13 Standard
- । Torsional test
- Axial pullout test -
- Driving torque test(Insertion/Removal) -
ASTM F2193-14 Standard
- Static and fatigue bending strength of metallic spinal screw -
9. Conclusion
The PathLoc-SI Joint Fusion System is substantially equivalent to the unmodified device (K153656)