510(k) Report

510(k) · Cleared

Cleared

AccelFix Spinal Fixation System

K182544510(k) TraditionalCleared May 28, 2019253-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

L&K BIOMED Co., Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on May 28, 2019 as substantially equivalent to K171813 (L&K BIOMED Co., Ltd., 2017) and 8 other predicates after a 253-day review. Its family tree reaches back 13 generations to 1999. 10 later devices descend from it.

Decided
May 28, 2019
Review
253 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
9

Its longest line of descent runs back 13 generations to K990745 (1999). 151 ancestors in all, the oldest K901587 (1990). 10 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2016: 1 other ancestor2009: 6 other ancestors2006: 11 other ancestors2003: 10 other ancestors2001: 11 other ancestors2000: 15 other ancestors1998: 8 other ancestors2012: 2 other ancestors2010: 3 other ancestors2002: 5 other ancestors1997: 4 other ancestors1995: 5 other ancestors1994: 2 other ancestors2007: 6 other ancestors2005: 13 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors2011: 1 other ancestor2008: 9 other ancestors2004: 10 other ancestors1999: 4 other ancestors1996: 2 other ancestors2023: 4 descendants cleared2022: 1 descendant cleared2020: 2 descendants cleared2026: 3 descendants clearedK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999K992739 · Click'x · Synthes Spine · 2000 · recalledK040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005K061202 · Revere Stabilization System · Globus Medical, Inc. · 2006K081195 · Revere Uniplanar Screws · Globus Medical, Inc. · 2008K091782 · Revere 6.35 Stabilization System · Globus Medical, Inc. · 2009×2: 2 generations cleared close together, K093294 (2010), K100788 (2010) K102488 · Apex Spine System W/ Cocr Rods · Spinecraft, LLC · 2010K120270 · Venus Spinal Fixation System · L&K BIOMED Co., Ltd. · 2012K143363 · VENUS Spinal Fixation System · L&K BIOMED Co., Ltd. · 2015K171813 · OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System · L&K BIOMED Co., Ltd. · 20171990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 12 other ancestors3 generations back: 18 other ancestors4 generations back: 18 other ancestors5 generations back: 42 other ancestors6 generations back: 21 other ancestors7 generations back: 8 other ancestors8 generations back: 7 other ancestors9 generations back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K171813 · OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System · L&K BIOMED Co., Ltd. · 2017K143363 · VENUS Spinal Fixation System · L&K BIOMED Co., Ltd. · 2015K120270 · Venus Spinal Fixation System · L&K BIOMED Co., Ltd. · 2012K102488 · Apex Spine System W/ Cocr Rods · Spinecraft, LLC · 2010K100788 · Cocr Rods · Globus Medical, Inc. · 2010K093294 · Revere Stabilization System · Globus Medical, Inc. · 2010K091782 · Revere 6.35 Stabilization System · Globus Medical, Inc. · 2009K081195 · Revere Uniplanar Screws · Globus Medical, Inc. · 2008K061202 · Revere Stabilization System · Globus Medical, Inc. · 2006K052069 · Protex Stabilization System with Additional Componentes · Globus Medical, Inc. · 2005K040442 · Protex Stabilization System · Globus Medical, Inc. · 2004K992739 · Click'x · Synthes Spine · 2000 · recalledK990745 · Modification to Synthes Universal Spinal System · Synthes Spine · 1999−10−50
  1. Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 9 generations between
  3. 3 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
  4. 2 generations backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
  5. 1 generation backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
  6. This deviceK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019
  7. Descendant · cites it directly · 8 of its ownK200794 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
  8. Descendant · cites it directly · 4 of its ownK223565 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2022
  9. Descendant · cites it directly · 3 of its ownK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  10. Descendant · 2 generations on · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
  11. Descendant · cites it directly · 2 of its ownK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
Show all 13 generations
  1. Root · 13 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 12 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 11 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
  4. 10 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
  5. 9 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
  6. 8 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
  7. 7 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
  8. 6 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
  9. 5 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
  10. 4 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
  11. 3 generations backK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
  12. 2 generations backK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
  13. 1 generation backK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
  14. This deviceK182544 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2019

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2020: 22022: 12023: 42026: 3
2020high 4 (2023) · low 0 (2021)2026

Most influential descendants

Showing 5 of 10 · See all
  • K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly8descendants
  • K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2022 · cites it directly4descendants
  • K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly3descendants
  • K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · 2 generations on2descendants
  • K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−12K992739Click'xSynthes Spine20001
−11K040442Protex Stabilization SystemGlobus Medical, Inc.2004—
−10K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005—
−9K061202Revere Stabilization SystemGlobus Medical, Inc.2006—
−8K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008—
−7K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009—
−6K093294Revere Stabilization SystemGlobus Medical, Inc.2010—
−5K100788Cocr RodsGlobus Medical, Inc.2010—
−4K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010—
−3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012—
−2K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.2015—
−1K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.2017—
0 (this device)K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2019—
+1K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2020—
+1K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2022—
+1K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+2K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.2023—
+1K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199020
199250
199320
199420
199550
199620
199740
199880
199940
2000150
2001110
200250
2003100
2004100
2005130
2006110
200760
200890
200960
201030
201110
201220
201610
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202020
202210
202340
202630
FIG. 1 — Lineage of K182544, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
Summary page 4
…AccelFix Spinal Fixation System’ are substantially equivalent to the following predicate(s): • Primary predicate device: OpenLoc-L Spinal Fixation System (K171813), • Additional predicate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyp…
L&K BIOMED Co., Ltd.2017—
*K974749Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior…
Summary page 4
…Primary predicate device: OpenLoc-L Spinal Fixation System (K171813), • Additional predicate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K…
Cross Medical Products, Inc.1998—
*K000236Synergy VLS Cap Nut Models 2206, 6102
Summary page 4
…ary predicate device: OpenLoc-L Spinal Fixation System (K171813), • Additional predicate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585),…
Interpore Cross Intl.2000—
*K011437Synergy 4.0 MM, 4.5 MM VLS Screws
Summary page 4
…cate device: OpenLoc-L Spinal Fixation System (K171813), • Additional predicate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedi…
Interpore Cross Intl.2001—
*K172546AnyPlus® Spinal Fixation System
Summary page 4
…tem (K171813), • Additional predicate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedicle Screw System (K053573) an…
GS Medical Co., Ltd.2017—
*K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)
Summary page 4
…ate device: Synergy Spinal System VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedicle Screw System (K053573) and PathLoc-L MIS Spinal System (K161766) ===…
U&I Corp.2009—
*K031585U&I, Optima, Spinal System
Summary page 4
…m VLS Closed/Opened (K974749,K000236, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedicle Screw System (K053573) and PathLoc-L MIS Spinal System (K161766)…
U&I Corp., America20035
*K053573GSS Pedicle Screw System
Summary page 4
…, K011437), Anyplus Spinal Fixation System (K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedicle Screw System (K053573) and PathLoc-L MIS Spinal System (K161766) K182…
GS Medical Co., Ltd.2006—
*K161766PathLoc-L MIS Spinal System
Summary page 4
…(K172546), Perfix Spinal System (K091725), Optima Spinal System (K031585), GSS Pedicle Screw System (K053573) and PathLoc-L MIS Spinal System (K161766) K182544 - Page 2 of 3 4. Description of…
L&K BIOMED Co., Ltd.2016—

Also cleared against K171813: 6 other devices →

What descends from it? (10)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208
K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224
K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233
K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232
K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231
K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260
K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200

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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 13 of the 151 ancestors have a recall of any class.
  • Of its descendants, K200794 (L&K BIOMED Co., Ltd., 2020) has gone furthest, with 8 descendants of its own.
  • 6 other devices also cite its predicate K171813.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), 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 disc disease (defined as discogenic back pain with…

Read the full statement (99 words)

The AccelFix Spinal Fixation System is intended for use as a posterior pedicle screw system (T1-S2/ilium), or as an anterolateral fixation system (T8-L5), 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 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.

Also cleared against K171813

6 other devices cite the same predicate.

  • K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2023
  • K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.L&K BIOMED Co., Ltd. · 2023
  • K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2023
  • K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.L&K BIOMED Co., Ltd. · 2022
  • K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2020
  • K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2018

More from L&K BIOMED Co., Ltd.

58 FDA decisions under this applicant name. See the company

  • K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd. · 2026
  • K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd. · 2026
  • K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
  • K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd. · 2026

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K182544 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182544: AccelFix Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182544

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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