510(k) · Cleared
ClearedLnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-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 Dec 4, 2020 as substantially equivalent to K182544 (L&K BIOMED Co., Ltd., 2019) and 4 other predicates after a 253-day review. Its family tree reaches back 14 generations to 1999.
- Decided
- Dec 4, 2020
- Review
- 253 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K990745 (1999). 153 ancestors in all, the oldest K901587 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations between
- 3 generations backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
- 2 generations backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
- 1 generation backK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- This deviceK200789 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS…L&K BIOMED Co., Ltd. · 2020
Show all 14 generations
- Root · 14 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 13 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 12 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 11 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 10 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 9 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 8 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 7 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 6 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 5 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 4 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 3 generations backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
- 2 generations backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
- 1 generation backK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- This deviceK200789 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS…L&K BIOMED Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −13 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −12 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −11 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −10 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −9 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −8 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −7 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −6 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −5 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −4 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −3 | K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| −2 | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | 2017 | — |
| −1 | K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 15 | 0 |
| 2001 | 11 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 10 | 0 |
| 2005 | 13 | 0 |
| 2006 | 11 | 0 |
| 2007 | 6 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | K182544 | AccelFix Spinal Fixation SystemSummary page 5…the predicate devices. The systems have same design, scientific technology, and indications for use. Primary Predicate: AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K1… | 2019 |
| * | K112643 | Focus Mis SystemSummary page 5…Primary Predicate: AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117) 4. Description of the Device The MIS spinal system consists of cannulated poly screws, s… | 2012 |
| * | K120140 | Focus Spinal SystemSummary page 5…rimary Predicate: AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117) 4. Description of the Device The MIS spinal system consists of cannulated poly screws, straight r… | 2012 |
| * | K161766 | PathLoc-L MIS Spinal SystemSummary page 5…edicate: AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117) 4. Description of the Device The MIS spinal system consists of cannulated poly screws, straight rods, curv… | 2016 |
| * | K183117 | PathLoc-L MIS Spinal SystemSummary page 5…AccelFix-MIS Spinal System (K182544) Additional predicates: LnK MIS Spinal System and PathLoc-L MIS Spinal System (K112643, K120140, K161766, K183117) 4. Description of the Device The MIS spinal system consists of cannulated poly screws, straight rods, curved rods a… | 2018 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 153 ancestors have a recall of any class.
- 6 other devices also cite its predicate K182544.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 MIS Spinal Systems are 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 MIS Spinal System can be used in an open approach and a percutaneous approach. The MIS Spinal System is intended for the following indications: Degenerative disc disease (defined as back pain…
Read the full statement (208 words)
The MIS Spinal Systems are 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 MIS Spinal System can be used in an open approach and a percutaneous approach.
The 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
The MIS Spinal Systems are 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 MIS Spinal System can be used in an open approach and a percutaneous approach.
The 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/K200789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200789: LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-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/K200789
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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