510(k) · Cleared
ClearedAccelFix 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 May 5, 2026 as substantially equivalent to K232311 (L&K BIOMED Co., Ltd., 2023) and 1 other predicate after a 29-day review. Its family tree reaches back 21 generations to 2004. 1 of the 329 devices in its family, counting itself, has a Class I recall.
- Decided
- May 5, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K040583 (2004). 328 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 329 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- 2 generations backK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- 1 generation backK232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- This deviceK261130 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 6 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- 5 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- 4 generations backK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
- 3 generations backK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- 2 generations backK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- 1 generation backK232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
- This deviceK261130 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
Class I recalls in this family
- K100952 Modification to Synthes Matrix System4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −8 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −6 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| −5 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| −4 | K181139 | OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC | 2018 | — |
| −3 | K230245 | LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal… | L&K BIOMED Co., Ltd. | 2023 | — |
| −2 | 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 | — |
| 0 (this device) | K261130 | AccelFix Spinal Fixation System | L&K BIOMED Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 22 | 0 |
| 2001 | 23 | 0 |
| 2002 | 14 | 0 |
| 2003 | 18 | 0 |
| 2004 | 23 | 0 |
| 2005 | 26 | 0 |
| 2006 | 21 | 0 |
| 2007 | 15 | 0 |
| 2008 | 17 | 0 |
| 2009 | 15 | 0 |
| 2010 | 18 | 1 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 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.
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 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? (2)
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 |
|---|---|---|---|
| * | K232311 | LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…Summary page 5…Product Code(s) NKB, KWP, KWQ I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232311 AccelFix Spinal Fixation System NKB K182544 AccelFix Spinal Fixation System NKB Device Description Summary 21 CFR 807.92(a)(4) T… | 2023 |
| * | K182544 | AccelFix Spinal Fixation SystemSummary page 5…keted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K232311 AccelFix Spinal Fixation System NKB K182544 AccelFix Spinal Fixation System NKB Device Description Summary 21 CFR 807.92(a)(4) The AccelFix Spinal Fixation System is a post… | 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.
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 5 months on median.
- 32 of the 328 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 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…
Read the full statement (100 words)
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261130: AccelFix 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/K261130
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026