510(k) Report

510(k) · Cleared

Cleared

Venus Spinal Fixation System

K120270510(k) TraditionalCleared Mar 26, 201256-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 Mar 26, 2012 as substantially equivalent to K100706 (L&K BIOMED Co., Ltd., 2010) and 10 other predicates after a 56-day review. Its family tree reaches back 10 generations to 1999. 111 later devices descend from it.

Decided
Mar 26, 2012
Review
56 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
11

Its longest line of descent runs back 10 generations to K990745 (1999). 113 ancestors in all, the oldest K944736 (1995). 111 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2010: 3 other ancestors2009: 5 other ancestors2008: 7 other ancestors2007: 4 other ancestors2006: 8 other ancestors2003: 10 other ancestors2005: 13 other ancestors2002: 5 other ancestors2001: 9 other ancestors2000: 13 other ancestors1997: 3 other ancestors1995: 3 other ancestors1998: 6 other ancestors1996: 2 other ancestors2004: 7 other ancestors1999: 4 other ancestors2013: 2 descendants cleared2023: 15 descendants cleared2020: 11 descendants cleared2015: 5 descendants cleared2018: 8 descendants cleared2022: 9 descendants cleared2012: 1 descendant cleared2014: 4 descendants cleared2016: 1 descendant cleared2017: 6 descendants cleared2019: 5 descendants cleared2026: 14 descendants cleared2021: 6 descendants cleared2024: 13 descendants cleared2025: 11 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 · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 35 other ancestors3 generations back: 24 other ancestors4 generations back: 19 other ancestors5 generations back: 7 other ancestors6 generations back: 8 other ancestors 1 generation forward: 9 descendants2 generations forward: 11 descendants3 generations forward: 12 descendants4 generations forward: 15 descendants5 generations forward: 18 descendants6 generations forward: 16 descendants7 generations forward: 18 descendants8 generations forward: 10 descendants9 generations forward: 2 descendants K102488 · 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+5
  1. Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 6 generations between
  3. 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
  4. 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
  5. 1 generation backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
  6. This deviceK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
  7. Descendant · cites it directly · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  8. Descendant · 2 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  9. Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  10. Descendant · cites it directly · 33 of its ownK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
  11. Descendant · 2 generations on · 30 of its ownK171813 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017
Show all 10 generations
  1. Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
  2. 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
  3. 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
  4. 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
  5. 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
  6. 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
  7. 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
  8. 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
  9. 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
  10. 1 generation backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
  11. This deviceK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2012: 12013: 22014: 42015: 52016: 12017: 62018: 82019: 52020: 112021: 62022: 92023: 152024: 132025: 112026: 14
2012high 15 (2023) · low 1 (2012)2026

Most influential descendants

Showing 5 of 111 · See all
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · cites it directly75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
  • K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly33descendants
  • K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2017 · 2 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K990745Modification to Synthes Universal Spinal SystemSynthes Spine1999—
−9K992739Click'xSynthes Spine20001
−8K040442Protex Stabilization SystemGlobus Medical, Inc.2004—
−7K052069Protex Stabilization System with Additional ComponentesGlobus Medical, Inc.2005—
−6K061202Revere Stabilization SystemGlobus Medical, Inc.2006—
−5K081195Revere Uniplanar ScrewsGlobus Medical, Inc.2008—
−4K091782Revere 6.35 Stabilization SystemGlobus Medical, Inc.2009—
−3K093294Revere Stabilization SystemGlobus Medical, Inc.2010—
−2K100788Cocr RodsGlobus Medical, Inc.2010—
−1K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010—
0 (this device)K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012—
+1K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+2K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+1K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.2015—
+2K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199530
199620
199730
199860
199940
2000130
200190
200250
2003100
200470
2005130
200680
200740
200870
200950
201030
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201320
201440
201550
201610
201760
201880
201950
2020110
202160
202290
2023150
2024130
2025110
2026140
FIG. 1 — Lineage of K120270, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (11)

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
*K100706Venus Basic Spinal Fixation System
Summary page 1
…Name: 3) Pedicle Screw Spinal System, 21 CFR §888.3070 3. Identification of Legally Marketed Devices L&K BIOMED: VENUS Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K0…
L&K BIOMED Co., Ltd.2010—
*K103085Venus Basic Spinal Fixation System
Summary page 1
…3) Pedicle Screw Spinal System, 21 CFR §888.3070 3. Identification of Legally Marketed Devices L&K BIOMED: VENUS Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K…
L&K BIOMED Co., Ltd.2011—
*K091717Any Plus Spinal Fixation System
Summary page 1
…3. Identification of Legally Marketed Devices L&K BIOMED: VENUS Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373…
GS Medical Co., Ltd.2010—
*K062513Apex Spine System
Summary page 1
…L&K BIOMED: VENUS Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Pol…
Spinecraft, Inc.2006—
*K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
Summary page 1
…MED: VENUS Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal a…
Spinecraft, Inc.2010—
*K102488Apex Spine System W/ Cocr Rods
Summary page 1
…S Spinal Fixation System (K100706,K103085) GS Medical: Anyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal and Synthe…
Spinecraft, LLC2010—
*K071373Stryker Spine Xia Iii Spinal SystemStryker Spine20071
*K083393Xia 3 Spinal System
Summary page 1
…nyplus Spinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal and Synthes UISS Iliosacral System (K022949,K082572) 4. Device Description…
Stryker Spine20091
*K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod
Summary page 1
…pinal Fixation System (K0917 17) Spine Craft: APEX Spine System (K062513,K092825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal and Synthes UISS Iliosacral System (K022949,K082572) 4. Device Description Th…
Stryker Spine2009—
*K022949Synthes Uss, Click'x, Uss Vas, Dual-Opening Uss and Small Stature Uss
Summary page 1
…92825, K102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal and Synthes UISS Iliosacral System (K022949,K082572) 4. Device Description This system is comprised of screws, set screws, rods, crosslink and connectors. The…
Synthes (Usa)2003—
*K082572Uss Iliosacral, Uss Polyaxial
Summary page 1
…102488) Stryker Spine: Xia&lll Spinal System (K071I373,K083393,K09 1291) Synthes Spine: USS Polyaixal and Synthes UISS Iliosacral System (K022949,K082572) 4. Device Description This system is comprised of screws, set screws, rods, crosslink and connectors. The compon…
Synthes Spine2008—

Also cleared against K100706: 5 other devices →

What descends from it? (111)

See all 111

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

NumberDeviceApplicantDecidedDescendants
K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)201375
K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533
K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205
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
K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183
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
K121568Dali Spinal Fixation SystemAccel Spine20121

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 13 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 12 of the 113 ancestors have a recall of any class.
  • Of its descendants, K123549 (Biomet Spine (Aka Ebi, LLC), 2013) has gone furthest, with 75 descendants of its own.
  • 5 other devices also cite its predicate K100706.

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. 2012, 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?

VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (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 (227 words)

VENUS Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (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)

The VENUS Spinal Fixation System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 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 VENUS 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.

Also cleared against K100706

5 other devices cite the same predicate.

  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 20132 recalls
  • K121568Dali Spinal Fixation SystemAccel Spine · 2012
  • K120140Focus Spinal SystemL&K BIOMED Co., Ltd. · 2012
  • K112643Focus Mis SystemL&K BIOMED Co., Ltd. · 2012
  • K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011

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/K120270 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120270: Venus 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/K120270

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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