510(k) · Cleared
ClearedLnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix 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 Dec 23, 2022 as substantially equivalent to K120270 (L&K BIOMED Co., Ltd., 2012) and 6 other predicates after a 24-day review. Its family tree reaches back 15 generations to 1999. 4 later devices descend from it.
- Decided
- Dec 23, 2022
- Review
- 24 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K990745 (1999). 155 ancestors in all, the oldest K901587 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations between
- 3 generations backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
- 2 generations backK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- 1 generation backK200794 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
- This deviceK223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK261130 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 14 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 13 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 12 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 11 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 10 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 9 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 8 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 7 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 6 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 5 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- 4 generations backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
- 3 generations backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
- 2 generations backK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
- 1 generation backK200794 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
- This deviceK223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly3descendants
- K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
- K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly1descendant
- K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −14 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −13 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −12 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −11 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −10 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −9 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −8 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −7 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −6 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −5 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| −4 | K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| −3 | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | 2017 | — |
| −2 | K182544 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2019 | — |
| −1 | K200794 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2020 | — |
| 0 (this device) | K223565 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2022 | — |
| +1 | K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2023 | — |
| +1 | K231636 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2023 | — |
| +1 | K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2023 | — |
| +2 | K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026 | — |
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 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 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? (7)
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 |
|---|---|---|---|
| * | K120270 | Venus Spinal Fixation SystemSummary page 5…ientific technology, and indications for use. LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System Primary predicate: LnK Spinal Fixation System (K120270) Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168… | 2012 |
| * | K143363 | VENUS Spinal Fixation SystemSummary page 5…m Primary predicate: LnK Spinal Fixation System (K120270) Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168, K 200790) AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System… | 2015 |
| * | K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemSummary page 5… Primary predicate: LnK Spinal Fixation System (K120270) Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168, K 200790) AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System (K182544)… | 2017 |
| * | K183168 | OpenLoc-L Spinal Fixation SystemSummary page 5…predicate: LnK Spinal Fixation System (K120270) Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168, K 200790) AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System (K182544) … | 2018 |
| * | K200790 | LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemSummary page 5…e: LnK Spinal Fixation System (K120270) Additional predicates: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System (K143363, K171813, K183168, K 200790) AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System (K182544) Additiona… | 2020 |
| * | K182544 | AccelFix Spinal Fixation SystemSummary page 5…pinal Fixation System (K143363, K171813, K183168, K 200790) AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System (K182544) Additional predicate: AccelFix Spinal Fixation System (K200794)… | 2019 |
| * | K200794 | AccelFix Spinal Fixation SystemSummary page 5…AccelFix Spinal Fixation System Primary Predicate: AccelFix Spinal Fixation System (K182544) Additional predicate: AccelFix Spinal Fixation System (K200794) K223565… | 2020 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 23 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 155 ancestors have a recall of any class.
- Of its descendants, K230245 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K120270.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a 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. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as…
Read the full statement (204 words)
The LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System is a non-cervical spinal fixation device intended for use as a 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. This device is indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc 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 AccelFix Spinal Fixation System is a non-cervical spinal fixation device intended for use as a 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 disc 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223565: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223565
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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