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510(k) K251741

PathLoc Lumbar Interbody Fusion Cage System by L&K BIOMED Co., Ltd. — Product Code MAX

K251741 is an FDA 510(k) premarket notification submitted by L&K BIOMED Co., Ltd. for the device "PathLoc Lumbar Interbody Fusion Cage System". The FDA issued a decision of Substantially Equivalent on July 8, 2025. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. L&K BIOMED Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2025
Date Received
June 6, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by L&K BIOMED Co., Ltd.

  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K261112 — CastleLoc-P Anterior Cervical Plate System (May 6, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K260448 — CastleLoc Pectus Bar System (March 19, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K250892 — CastleLoc Pectus Bar System (April 25, 2025)
  • K243357 — CastleLoc Pectus Bar System (February 27, 2025)
  • K242829 — BluEX Lumbar Expandable Cage System (October 23, 2024)
  • K240201 — PathLoc SI Joint Fusion System (February 23, 2024)
  • K231680 — AccelFix Lumbar Expandable Cage System (August 24, 2023)

Other clearances for product code MAX

  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)
  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)

FDA data resources