PathLoc SI Joint Fusion System
FDA 510(k) K240201 · L&K BIOMED Co., Ltd.
510(k) numberK240201
Submission
- Device name
- PathLoc SI Joint Fusion System
- Applicant
- L&K BIOMED Co., Ltd.
Yongin-Si, KR - Received
- January 25, 2024
- Decision date
- February 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
Other 510(k)s with product code OUR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
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| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | 05/16/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | 05/06/2026SE |
| K261130 | AccelFix Spinal Fixation SystemNKB · Special | 05/05/2026SE |
| K260448 | CastleLoc Pectus Bar SystemHRS · Special | 03/19/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | 03/03/2026SE |
| K251741 | PathLoc Lumbar Interbody Fusion Cage SystemMAX · Special | 07/08/2025SE |
| K250892 | CastleLoc Pectus Bar SystemHRS · Special | 04/25/2025SE |
| K243357 | CastleLoc Pectus Bar SystemHRS · Traditional | 02/27/2025SE |
| K242829 | BluEX Lumbar Expandable Cage SystemMAX · Traditional | 10/23/2024SE |
Questions and answers
When was PathLoc SI Joint Fusion System cleared by the FDA?
PathLoc SI Joint Fusion System (K240201) received a 510(k) decision of Substantially Equivalent on February 23, 2024, 29 days after the submission was received.
What is the product code of K240201?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.