510(k) · Cleared
ClearedPathLoc-L MIS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 15, 2018 as substantially equivalent to K161766 (L&K BIOMED Co., Ltd., 2016) after a 6-day review. Its family tree reaches back 10 generations to 1995. 4 later devices descend from it.
- Decided
- Nov 15, 2018
- Review
- 6 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K950697 (1995). 65 ancestors in all, the oldest K933881 (1994). 4 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 6 generations between
- 3 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK161766 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016
- This deviceK183117 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK252139 Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK200789 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS…L&K BIOMED Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 9 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 8 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 7 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 6 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 5 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 4 generations backK090648 Viper 2 SystemDepuy Spine, Inc. · 2009
- 3 generations backK112643 Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
- 2 generations backK120140 Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK161766 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2016
- This deviceK183117 PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · See all- K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020 · cites it directly1descendant
- K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026 · cites it directly0descendants
- K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024 · 2 generations on0descendants
- K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −9 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −8 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −7 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −6 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −5 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −4 | K090648 | Viper 2 System | Depuy Spine, Inc. | 2009 | — |
| −3 | K112643 | Focus Mis System | L&K BIOMED Co., Ltd. | 2012 | — |
| −2 | K120140 | Focus Spinal System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K161766 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2016 | — |
| 0 (this device) | K183117 | PathLoc-L MIS Spinal System | L&K BIOMED Co., Ltd. | 2018 | — |
| +1 | K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020 | — |
| +1 | K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | 2026 | — |
| +2 | K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024 | — |
| +1 | K200789 | LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System | L&K BIOMED Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K161766 | PathLoc-L MIS Spinal SystemSummary page 4…BIOMED Co. Ltd., is submitting this Special 510(k) to add new components and to change part number of two set screws of the existing 510(k)-cleared device (K161766) 4. The name of the legally marketed (unmodified) device K161766 PathLoc-L MIS Spinal System (primary predicate)… | 2016 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 65 ancestors have a recall of any class.
- Of its descendants, K200267 (Corentec Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K161766.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The PathLoc-L MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach. The PathLoc-L MIS Spinal System is intended for the following indications: * Degenerative disc…
Read the full statement (115 words)
The PathLoc-L MIS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The PathLoc-L MIS Spinal System can be used in an open approach and a percutaneous approach.
The PathLoc-L MIS Spinal System is intended for the following indications:
* Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
* Spondylolisthesis
* Trauma (i.e., fracture or dislocation)
* Spinal stenosis
* Curvatures (i.e., scoliosis, kyphosis, lordosis)
* Tumor
* Pseudarthrosis
* Failed previous fusion
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/K183117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183117: PathLoc-L MIS Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183117
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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