510(k) Report

510(k) · Cleared

Cleared

PASS LP Spinal System

K161627510(k) TraditionalCleared Jul 29, 201646-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

Medicrea International SA · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 29, 2016 as substantially equivalent to K141398 (Medicrea International SA, 2015) and 2 other predicates after a 46-day review. Its family tree reaches back 10 generations to 2004. 7 later devices descend from it.

Decided
Jul 29, 2016
Review
46 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 10 generations to K040583 (2004). 122 ancestors in all, the oldest K781443 (1978). 7 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2015: 1 other ancestor1997: 2 other ancestors2014: 1 other ancestor2013: 1 other ancestor1996: 4 other ancestors2011: 3 other ancestors2010: 4 other ancestors2009: 3 other ancestors2008: 8 other ancestors2006: 6 other ancestors2005: 10 other ancestors2004: 14 other ancestors2003: 9 other ancestors2007: 5 other ancestors2002: 8 other ancestors2000: 13 other ancestors1999: 2 other ancestors2001: 12 other ancestors1998: 4 other ancestors1984: 1 other ancestor1978: 1 other ancestor2017: 1 descendant cleared2018: 2 descendants cleared2025: 2 descendants cleared2019: 1 descendant cleared2022: 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) K141494 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 16 other ancestors4 generations back: 31 other ancestors5 generations back: 19 other ancestors6 generations back: 14 other ancestors7 generations back: 16 other ancestors8 generations back: 6 other ancestors9 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K141494 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K091974 · 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 · 2004−10−50
  1. Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 6 generations between
  3. 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  4. 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  5. 1 generation backK141494 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  6. This deviceK161627 PASS LP Spinal SystemMedicrea International SA · 2016
  7. Descendant · cites it directly · 6 of its ownK162786 PASS LP Spinal SystemMedicrea International SA · 2017
  8. Descendant · 2 generations on · 2 of its ownK182239 OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018
  9. Descendant · 2 generations on · 2 of its ownK182240 PASS LP Spinal SystemMedicrea International SA · 2018
  10. Descendant · 3 generations on · 1 of its ownK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
  11. Descendant · 3 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
Show all 10 generations
  1. Root · 10 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 8 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 7 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 6 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 5 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 4 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 3 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 2 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 1 generation backK141494 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  11. This deviceK161627 PASS LP Spinal SystemMedicrea International SA · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017: 12018: 22019: 12022: 12025: 2
2017high 2 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K162786PASS LP Spinal SystemMedicrea International SA · 2017 · cites it directly6descendants
  • K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC · 2018 · 2 generations on2descendants
  • K182240PASS LP Spinal SystemMedicrea International SA · 2018 · 2 generations on2descendants
  • K190376PASS LP Spinal SystemMedicrea International SA · 2019 · 3 generations on1descendant
  • K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−9K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−8K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−7K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−6K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−5K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−4K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−3K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−2K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−1K141494CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
0 (this device)K161627PASS LP Spinal SystemMedicrea International SA2016—
+1K162786PASS LP Spinal SystemMedicrea International SA2017—
+2K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC2018—
+2K182240PASS LP Spinal SystemMedicrea International SA2018—
+3K190376PASS LP Spinal SystemMedicrea International SA20195
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199640
199720
199840
199920
2000130
2001120
200280
200390
2004140
2005100
200660
200750
200880
200930
201040
201130
201310
201410
201510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
201910
202210
202520
FIG. 1 — Lineage of K161627, 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
*K141398Pass LP Spinal System
Summary page 4
…tion Product Code: NKB, Subsequent Product Code: KWP, MNH, MNI, and OSH 3. PREDICATE DEVICE Primary Predicate:  PASS LP Spinal System, MEDICREA INTERNATIONAL, K141398 This predicate has not-been subject to a design-related recall. Additional Predicates:  MOSS Miami Spinal System, DEPUY,…
Medicrea International SA20151
*K964024Depuy Motech Titanium Moss Miami Spinal System
Summary page 4
…System, MEDICREA INTERNATIONAL, K141398 This predicate has not-been subject to a design-related recall. Additional Predicates:  MOSS Miami Spinal System, DEPUY, K964024  CD HORIZON Spinal System, MEDTRONIC SOFAMOR DANEK, K141494…
Depuy, Inc.1997—
*K141494CD Horizon Spinal System
Summary page 4
…not-been subject to a design-related recall. Additional Predicates:  MOSS Miami Spinal System, DEPUY, K964024  CD HORIZON Spinal System, MEDTRONIC SOFAMOR DANEK, K141494 K161627…
Medtronic Sofamor Danek USA, Inc.2014—

Also cleared against K141398: 3 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K162786PASS LP Spinal SystemMedicrea International SA20176

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 12 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 14 of the 122 ancestors have a recall of any class.
  • Of its descendants, K162786 (Medicrea International SA, 2017) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K141398.

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. 2016, 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 K141398

3 other devices cite the same predicate.

  • K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
  • K160640PASS XS Spinal SystemMedicrea International SA · 2016
  • K153413PASS LP Spinal SystemMedicrea International SA · 2016

More from Medicrea International SA

25 FDA decisions under this applicant name. See the company

  • K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SA · 2022
  • K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
  • K210470C-CURVE Interbody Fusion DeviceMedicrea International SA · 2021
  • K200316UNiD IB3D ALIFMedicrea International SA · 2020
  • K191134IB3D AlifMedicrea International SA · 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/K161627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K161627: PASS LP Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161627

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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