510(k) · Cleared
ClearedOpenLoc-L Spinal Fixation System, LnK Spinal Fixation 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 Jul 13, 2017 as substantially equivalent to K143363 (L&K BIOMED Co., Ltd., 2015) after a 24-day review. Its family tree reaches back 12 generations to 1999. 30 later devices descend from it.
- Decided
- Jul 13, 2017
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K990745 (1999). 115 ancestors in all, the oldest K944736 (1995). 30 later devices descend from it, 7 citing it directly.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
- Descendant · cites it directly · 23 of its ownK183168 OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2018
- Descendant · 2 generations on · 16 of its ownK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 4 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 10 of its ownK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 1 generation backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
- This deviceK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2018 · cites it directly23descendants
- K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on16descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 4 generations on11descendants
- K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −9 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −8 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −7 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −6 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −5 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −4 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −3 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −1 | K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| 0 (this device) | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | 2017 | — |
| +1 | K183168 | OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. | 2018 | — |
| +2 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +4 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 13 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 13 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K143363 | VENUS Spinal Fixation SystemSummary page 4…d intended use as the predicate device. 4. Predicate or legally marketed devices which are substantially equivalent „ LnK Spinal Fixation System K143363 5. Description of the Device This system is comprised of screws, set screws, rods, crosslink, Hook and c… | 2015 |
What descends from it? (30)
See all 307 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183168 | OpenLoc-L Spinal Fixation System | 2018 | 23 |
| K182544 | AccelFix Spinal Fixation System | 2019 | 10 |
| K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System | 2020 | 5 |
| K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation… | 2022 | 4 |
| K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation… | 2023 | 3 |
| K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation… | 2023 | 2 |
| K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation… | 2023 | 1 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 115 ancestors have a recall of any class.
- Of its descendants, K183168 (L&K BIOMED Co., Ltd., 2018) has gone furthest, with 23 descendants of its own.
- 6 other devices also cite its predicate K143363.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disF disease (defined as discogenic back pain with…
Read the full statement (220 words)
OpenLoc-L Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation system T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disF disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; stenosis; and failed previous fusion (pseudoarthrosis).
The OpenLoc-L Spinal Fixation System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the OpenLoc-L Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171813: OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171813
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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