510(k) Report

510(k) · Cleared

Cleared

OLYMPIC Posterior Spinal Fixation System

K182239510(k) TraditionalCleared Oct 18, 201859-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 Oct 18, 2018 as substantially equivalent to K170496 (Stryker Corporation, 2017) and 2 other predicates after a 59-day review. Its family tree reaches back 19 generations to 2004. 2 later devices descend from it.

Decided
Oct 18, 2018
Review
59 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 19 generations to K040583 (2004). 363 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2010: 22 other ancestors2016: 1 other ancestor2015: 2 other ancestors2007: 17 other ancestors2006: 24 other ancestors2005: 24 other ancestors2004: 27 other ancestors2002: 20 other ancestors1998: 16 other ancestors1995: 9 other ancestors2014: 2 other ancestors2013: 5 other ancestors2012: 5 other ancestors2009: 16 other ancestors2008: 23 other ancestors2003: 19 other ancestors2001: 27 other ancestors2000: 25 other ancestors1997: 9 other ancestors1996: 10 other ancestors2011: 11 other ancestors1999: 11 other ancestors1994: 4 other ancestors1993: 4 other ancestors1978: 1 other ancestor1985: 1 other ancestor1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2025: 2 descendants 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. · 2014K152632 · XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory · Stryker Corporation · 2015K170496 · Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory · Stryker Corporation · 2017 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 10 other ancestors3 generations back: 35 other ancestors4 generations back: 73 other ancestors5 generations back: 80 other ancestors6 generations back: 61 other ancestors7 generations back: 45 other ancestors8 generations back: 17 other ancestors9 generations back: 11 other ancestors10 generations back: 7 other ancestors11 generations back: 3 other ancestors 1 generation forward: 2 descendants K170496 · Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory · Stryker Corporation · 2017 · recalledK152632 · XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory · Stryker Corporation · 2015K142381 · 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 · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations between
  3. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  4. 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  5. 1 generation backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  6. This deviceK182239 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  7. Descendant · cites it directly · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
  8. Descendant · cites it directly · 0 of its ownK243259 MASADA Modular Spinal Fixation SystemAstura Medical · 2025
Show all 19 generations
  1. Root · 19 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 17 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 16 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 15 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 14 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 13 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 12 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 11 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 10 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 9 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 8 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 7 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 6 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 5 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 4 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 3 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 2 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  19. 1 generation backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  20. This deviceK182239 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018

Most influential descendants

Showing 2 of 2 · See all
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · cites it directly0descendants
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−16K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−14K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−13K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−12K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−11K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−10K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−9K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−8K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−7K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−6K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−5K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−4K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−3K142381Xia 3 Spinal SystemStryker Corp.2014—
−2K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
−1K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation20171
0 (this device)K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018—
+1K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical2025—
+1K243259MASADA Modular Spinal Fixation SystemAstura Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199340
199440
199590
1996100
199790
1998160
1999110
2000250
2001270
2002200
2003190
2004270
2005240
2006240
2007170
2008230
2009160
2010220
2011110
201250
201350
201420
201520
201610
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
FIG. 1 — Lineage of K182239, 2004–2025Source: 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? (3)

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
*K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
Summary page 4
…on Name: ✓ Thoracolumbosacral pedicle screw system per NKB 888.3070 Regulatory Class: II Product Code: NKB, KWP c. PREDICATE DEVICE Xia® 3 Spinal System, K170496 (Primary) EXPEDIUM® Spine System, K102249 (Additional) PASS LP Spinal System, K162786 (Additional)…
Stryker Corporation20171
*K102249Expedium Spine System
Summary page 4
…w system per NKB 888.3070 Regulatory Class: II Product Code: NKB, KWP c. PREDICATE DEVICE Xia® 3 Spinal System, K170496 (Primary) EXPEDIUM® Spine System, K102249 (Additional) PASS LP Spinal System, K162786 (Additional)…
Depuy Spine, A Johnson & Johnson Company2010—
*K162786PASS LP Spinal System
Summary page 4
…II Product Code: NKB, KWP c. PREDICATE DEVICE Xia® 3 Spinal System, K170496 (Primary) EXPEDIUM® Spine System, K102249 (Additional) PASS LP Spinal System, K162786 (Additional) K18224…
Medicrea International SA2017—

Also cleared against K170496: 5 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250
K243259MASADA Modular Spinal Fixation SystemAstura Medical20250

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 14 years and passes through 7 companies; a new generation was cleared every 5 months on median.
  • 36 of the 363 ancestors have a recall of any class.
  • Of its descendants, K252346 (Astura Medical, 2025) has gone furthest, with 0 descendants of its own.
  • 5 other devices also cite its predicate K170496.

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 PASS LP Spinal System is a pedicle screw fixation system intended for 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)…

Read the full statement (167 words)

The PASS LP Spinal System is a pedicle screw fixation system intended for 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 (e.g., fracture or dislocation), deformity or curvature (e.g., scoliosis, kyphosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K170496

5 other devices cite the same predicate.

  • K253545Vulcan Spinal SystemK2m, Inc. · 2026
  • K222684XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA®…Stryker Spine · 2023
  • K202528Cannulated Power Driver AttachmentK2m, Inc. · 2020
  • K200666Stryker Xia 3 Power AdaptorStryker Spine · 2020
  • K182240PASS LP Spinal SystemMedicrea International SA · 2018

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/K182239 · printed Nov 5, 2026

Cite this page

510(k) Report. “K182239: OLYMPIC Posterior 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/K182239

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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