510(k) · Cleared
ClearedPathLoc Lumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 3, 2026 as substantially equivalent to K192481 (L&K BIOMED Co., Ltd., 2020) and 3 other predicates after a 252-day review. Its family tree reaches back 21 generations to 1985. 1 of the 280 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 3, 2026
- Review
- 252 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 21 generations to K853033 (1985). 279 ancestors in all. No later device cites it as a predicate yet. 1 of the 280 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 17 generations between
- 3 generations backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- 2 generations backK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- 1 generation backK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- This deviceK251940 PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 20 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 19 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 18 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 17 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 16 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 15 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 14 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 13 generations backK072568 Modification to Oasys SystemStryker Spine · 2007
- 12 generations backK080143 Modification to Stryker Spine Oasys SystemStryker Spine · 2008
- 11 generations backK093670 Modification to: Oasys SystemStryker Spine · 2010 · Recalled (Class I)
- 10 generations backK111719 Oasys Spinal SystemStryker Spine · 2012
- 9 generations backK142741 OASYS SystemStryker Corporation · 2015
- 8 generations backK150753 OASYS SystemStryker Corporation · 2015
- 7 generations backK151755 OASYS (r) SystemStryker Corporation · 2015
- 6 generations backK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- 5 generations backK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- 4 generations backK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- 3 generations backK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- 2 generations backK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- 1 generation backK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
- This deviceK251940 PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2026
Class I recalls in this family
- K093670 Modification to: Oasys System9 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −20 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −19 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −18 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −17 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −16 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −15 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −14 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −13 | K072568 | Modification to Oasys System | Stryker Spine | 2007 | — |
| −12 | K080143 | Modification to Stryker Spine Oasys System | Stryker Spine | 2008 | — |
| −11 | K093670 | Modification to: Oasys System | Stryker Spine | 2010 | Class I |
| −10 | K111719 | Oasys Spinal System | Stryker Spine | 2012 | — |
| −9 | K142741 | OASYS System | Stryker Corporation | 2015 | — |
| −8 | K150753 | OASYS System | Stryker Corporation | 2015 | — |
| −7 | K151755 | OASYS (r) System | Stryker Corporation | 2015 | — |
| −6 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| −5 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| −4 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| −3 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| −2 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| −1 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
| 0 (this device) | K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1992 | 6 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 6 | 0 |
| 1997 | 8 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 15 | 0 |
| 2002 | 16 | 0 |
| 2003 | 15 | 0 |
| 2004 | 14 | 0 |
| 2005 | 19 | 0 |
| 2006 | 21 | 0 |
| 2007 | 10 | 0 |
| 2008 | 15 | 0 |
| 2009 | 11 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 9 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 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.
1 device in this family has a Class I recall. 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K192481 | AccelFix Lumbar Plate SystemSummary page 5…888.3060 Product Code(s) KwQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192481 AccelFix Lumbar Plate System KWQ K173885 Binary® Lumbar Plate System KWQ K231839 AccelFix Lumbar Plate System KWQ K192678 Binary®… | 2020 |
| * | K173885 | Genesys Spine Binary Lumbar Plate SystemSummary page 5…Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192481 AccelFix Lumbar Plate System KWQ K173885 Binary® Lumbar Plate System KWQ K231839 AccelFix Lumbar Plate System KWQ K192678 Binary® Lumbar Plate System KWQ Device Descripti… | 2018 |
| * | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemSummary page 5…(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192481 AccelFix Lumbar Plate System KWQ K173885 Binary® Lumbar Plate System KWQ K231839 AccelFix Lumbar Plate System KWQ K192678 Binary® Lumbar Plate System KWQ Device Description Summary 21 CFR 807.92(a)(4) The syst… | 2023 |
| * | K192678 | Genesys Spine Binary® Lumbar Plate SystemSummary page 5…Primary Predicate is listed first) Product Code K192481 AccelFix Lumbar Plate System KWQ K173885 Binary® Lumbar Plate System KWQ K231839 AccelFix Lumbar Plate System KWQ K192678 Binary® Lumbar Plate System KWQ Device Description Summary 21 CFR 807.92(a)(4) The system consists of plates and fixation screws… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 9 generations back · ◆ on the line of descent in FIG. 11 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 1.3 years on median.
- 25 of the 279 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K192481.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The PathLoc Lumbar Plate System is indicated for use via the anterior surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of…
Read the full statement (102 words)
The PathLoc Lumbar Plate System is indicated for use via the anterior surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion.
This system is indicated in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc conformed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, scoliosis, spondylolisthesis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
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/K251940 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251940: PathLoc Lumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251940
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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