510(k) Report

510(k) · Cleared

Cleared

OLYMPIC Posterior Spinal Fixation System

K181139510(k) TraditionalCleared Jul 6, 201867-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

Astura Medical, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 6, 2018 as substantially equivalent to K153446 (Astura Medical, 2016) and 19 other predicates after a 67-day review. Its family tree reaches back 17 generations to 2004. 1 of the 287 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.

Decided
Jul 6, 2018
Review
67 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
20

Its longest line of descent runs back 17 generations to K040583 (2004). 278 ancestors in all, the oldest K781443 (1978). 8 later devices descend from it, 4 citing it directly. 1 of the 287 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 3 other ancestors2015: 2 other ancestors2013: 5 other ancestors2012: 5 other ancestors2011: 9 other ancestors2010: 14 other ancestors, 1 with a Class I recall12009: 14 other ancestors2007: 15 other ancestors2006: 18 other ancestors2000: 15 other ancestors1997: 6 other ancestors1996: 5 other ancestors1995: 6 other ancestors1992: 5 other ancestors2008: 14 other ancestors2005: 22 other ancestors2004: 23 other ancestors2003: 16 other ancestors2002: 12 other ancestors2001: 21 other ancestors1999: 10 other ancestors1993: 3 other ancestors1990: 2 other ancestors2014: 3 other ancestors1998: 9 other ancestors1978: 1 other ancestor1994: 1 other ancestor1984: 1 other ancestor1985: 1 other ancestor2023: 4 descendants cleared2024: 1 descendant cleared2025: 2 descendants cleared2026: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×3: 3 generations cleared close together, K131321 (2013), K132471 (2013), K140276 (2014) K142381 · Xia 3 Spinal System · Stryker Corp. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 19 other ancestors, 1 with a Class I recall12 generations back: 46 other ancestors3 generations back: 69 other ancestors4 generations back: 60 other ancestors5 generations back: 27 other ancestors6 generations back: 23 other ancestors7 generations back: 16 other ancestors8 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K142381 · Xia 3 Spinal System · Stryker Corp. · 2014K140276 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−15−10−50
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 13 generations between
  3. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  4. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  5. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  6. This deviceK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  7. Descendant · cites it directly · 3 of its ownK230245 LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  8. Descendant · cites it directly · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
  9. Descendant · cites it directly · 2 of its ownK231636 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  10. Descendant · 2 generations on · 1 of its ownK232311 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System…L&K BIOMED Co., Ltd. · 2023
  11. Descendant · 3 generations on · 0 of its ownK261130 AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026
Show all 17 generations
  1. Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 4 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 3 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 2 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 1 generation backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. This deviceK181139 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2023: 42024: 12025: 22026: 1
2023high 4 (2023) · low 1 (2024)2026

Class I recalls in this family

  • K100952 Modification to Synthes Matrix Systemdirect predicate · 2010

Most influential descendants

Showing 5 of 8 · See all
  • K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd. · 2023 · cites it directly3descendants
  • K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · cites it directly2descendants
  • 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 · 2 generations on1descendant
  • K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−14K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−12K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−10K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−9K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−8K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−7K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−6K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−5K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−4K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−2K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−1K142381Xia 3 Spinal SystemStryker Corp.2014—
0 (this device)K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018—
+1K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+1K231694MASADA Modular Spinal Fixation SystemAstura Medical2023—
+1K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal…L&K BIOMED Co., Ltd.2023—
+3K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199410
199560
199650
199760
199890
1999100
2000150
2001210
2002120
2003160
2004230
2005220
2006180
2007150
2008140
2009140
2010141
201190
201250
201350
201430
201520
201630

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202340
202410
202520
202610
FIG. 1 — Lineage of K181139, 2004–2026Source: 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.

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. #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? (20)

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
*K153446OLYMPIC Posterior Spinal Fixation System
Summary page 4
…KWP CFR Section 21 CFR section 888.3070 21 CFR section 888.3050 Device Panel Orthopedic Primary Predicate OLYMPIC PSFS (K153446) Device Secondary Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K1…
Astura Medical2016—
*K143633CREO Stabilization System
Summary page 4
…8.3050 Device Panel Orthopedic Primary Predicate OLYMPIC PSFS (K153446) Device Secondary Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060…
Globus Medical, Inc.2015—
*K124058Creo Stabilization System
Summary page 4
…hopedic Primary Predicate OLYMPIC PSFS (K153446) Device Secondary Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Exped…
Globus Medical, Inc.2013—
*K113395Revere 4.5 Stabilization System
Summary page 4
…imary Predicate OLYMPIC PSFS (K153446) Device Secondary Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper…
Globus Medical, Inc.2012—
*K142381Xia 3 Spinal System
Summary page 4
…Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Univ…
Stryker Corp.2014—
*K113666Xia 3 Spinal System
Summary page 4
…Revere®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spi…
Stryker Spine2012—
*K071373Stryker Spine Xia Iii Spinal System
Summary page 4
…®/CREO™ Stabilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System…
Stryker Spine20071
*K060748Modification to Xia 4.5 Spinal System
Summary page 4
…abilization System - Globus Medical (K143633 / Predicate K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix…
Stryker Spine2006—
*K111136Expedium Spine System, Viper System, Viper 2 System
Summary page 4
…K124058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miam…
Depuy Spine, Inc.20121
*K131802Expedium, Viper. Viper 2 Spine System
Summary page 4
…24058 / K113395) Device(s) Xia Spinal System - Stryker (K142381 /K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DeP…
Depuy Spine, A Johnson & Johnson Company2013—
*K111358Synthes Uss
Summary page 4
…/K113666 / K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cros…
Synthes Spine2011—
*K100952Modification to Synthes Matrix System
Summary page 4
…/ K071373 / K060748) Expedium/Viper - DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical…
Synthes Spine2010Class I
*K000536Synthes Anterior CSLP System
Summary page 4
…DePuy Spine (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy)…
Synthes Spine20001
*K955348Titanium Moss Miami Spinal System
Summary page 4
…ne (K111136 / K131802) Universal Spinal System / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross M…
Depuy, Inc.1996—
*K940631Cross Medical - Synergy (TM) Spine System
Summary page 4
…m / Matrix - Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtroni…
Cross Medical Products, Inc.1995—
*K950099Synergy (TM) TI Posterior Spinal System
Summary page 4
…- Synthes (K111358 / K100952) Moss Miami SS - DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtronic (K090390…
Buckman Co., Inc.1997—
*K920116PWB Lumbosacral Spine System
Summary page 4
…- DePuy Spine (K000536, K955348) Synergy VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtronic (K090390 / K162494 / K162379) Device Description The OLYMPIC PSFS is a…
Cross Medical Products, Inc.1992—
*K090390CD Horizon Spinal System
Summary page 4
…y VLS – open - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtronic (K090390 / K162494 / K162379) Device Description The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac…
Medtronic Sofamor Danek2009—
*K162494CD HORIZON® Spinal System
Summary page 4
…en - Cross Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtronic (K090390 / K162494 / K162379) Device Description The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac fixat…
Medtronic Sofamor Danek USA, Inc.2016—
*K162379CD HORIZON® Spinal System
Summary page 4
…Medical (K940631 / K950099) PWB (now Synergy) - Cross Medical (K920116) CD HORIZON LEGACY – Medtronic (K090390 / K162494 / K162379) Device Description The OLYMPIC PSFS is a top loading thoracolumbar, sacral, and iliac fixation system…
Medtronic Sofamor Danek USA, Inc.2016—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233
K231694MASADA Modular Spinal Fixation SystemAstura Medical20232
K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232
K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240

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 · Direct predicate · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 5 months on median.
  • 28 of the 278 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K230245 (L&K BIOMED Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.

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. 2018, 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 OLYMPIC Posterior 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 thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis…

Read the full statement (192 words)

The OLYMPIC Posterior 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 thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.

In addition, the OLYMPIC Posterior Spinal Fixation System is intended for 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 lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.

When used for posterior non-cervical pedicle and non-pedicle fixation in pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle and non-pedicle fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

More from Astura Medical, LLC

8 FDA decisions under this applicant name. See the company

  • K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
  • K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC · 2020
  • K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC · 2020
  • K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
  • K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019

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/K181139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181139: OLYMPIC Posterior 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/K181139

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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