510(k) · Cleared
ClearedPathLoc Lumbar Interbody Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 8, 2025 as substantially equivalent to K213441 (L&K BIOMED Co., Ltd., 2022) after a 32-day review. Its family tree reaches back 17 generations to 1984.
- Decided
- Jul 8, 2025
- Review
- 32 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K841189 (1984). 92 ancestors in all. No later device cites it as a predicate yet.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- 2 generations backK181380 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018
- 1 generation backK213441 PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2022
- This deviceK251741 PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 11 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 10 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 8 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 7 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 6 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 5 generations backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 4 generations backK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- 3 generations backK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- 2 generations backK181380 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018
- 1 generation backK213441 PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2022
- This deviceK251741 PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −11 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −10 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −8 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −7 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −6 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −5 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −4 | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| −3 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| −2 | K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018 | — |
| −1 | K213441 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2022 | — |
| 0 (this device) | K251741 | PathLoc Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K213441 | PathLoc Lumbar Interbody Fusion Cage SystemSummary page 5…ion Cage System’ is substantially equivalent to the following predicate(s); 1) Primary Predicate Device: PathLoc Lumbar Interbody Fusion Cage System (K 213441) The subject and predicate devices are substantially equivalent in the areas of materials, design, indications f… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 92 ancestors have a recall of any class.
- 1 other device also cites its predicate K213441.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is…
Read the full statement (117 words)
PathLoc Lumbar Interbody Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft and/or allogenous bone graft composed of cancellous and/or corticocancellous bone. PathLoc Lumbar Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251741: PathLoc Lumbar Interbody Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251741
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026