510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

PASS LP Spinal System

K190376510(k) TraditionalCleared May 2, 201972-day reviewClass II21 CFR 888.3070Recalls 5

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 May 2, 2019 as substantially equivalent to K124058 (Globus Medical, Inc., 2013) and 4 other predicates after a 72-day review. Its family tree reaches back 20 generations to 2004. 1 of the 397 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 5 times.

Decided
May 2, 2019
Review
72 days
Class
Class II
Product code
NKB
Recalls
5
Predicates
5

Its longest line of descent runs back 20 generations to K040583 (2004). 395 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 397 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2013: 6 other ancestors2007: 21 other ancestors2001: 32 other ancestors1996: 10 other ancestors2017: 1 other ancestor2012: 7 other ancestors2011: 14 other ancestors2010: 25 other ancestors, 1 with a Class I recall12004: 28 other ancestors2003: 22 other ancestors2002: 24 other ancestors2016: 1 other ancestor2015: 2 other ancestors2009: 18 other ancestors2008: 24 other ancestors2006: 24 other ancestors2005: 24 other ancestors2000: 25 other ancestors1998: 17 other ancestors1997: 9 other ancestors1995: 9 other ancestors2014: 2 other ancestors1999: 12 other ancestors1993: 4 other ancestors1994: 4 other ancestors1978: 1 other ancestor1984: 1 other ancestor1985: 1 other ancestor1992: 5 other ancestors1990: 2 other ancestors2022: 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. · 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 · recalledK182240 · PASS LP Spinal System · Medicrea International SA · 201819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 12 other ancestors, 1 with a Class I recall13 generations back: 43 other ancestors4 generations back: 83 other ancestors5 generations back: 91 other ancestors6 generations back: 52 other ancestors7 generations back: 32 other ancestors8 generations back: 30 other ancestors9 generations back: 8 other ancestors10 generations back: 10 other ancestors11 generations back: 7 other ancestors12 generations back: 3 other ancestors 1 generation forward: 1 descendant K182240 · PASS LP Spinal System · Medicrea International SA · 2018K170496 · 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 · 2004−20−15−10−50
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 16 generations between
  3. 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  4. 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  5. 1 generation backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
  6. This deviceK190376 PASS LP Spinal SystemMedicrea International SA · 2019
  7. Descendant · cites it directly · 0 of its ownK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Show all 20 generations
  1. Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 8 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 7 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 6 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 5 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 4 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 3 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  19. 2 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  20. 1 generation backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
  21. This deviceK190376 PASS LP Spinal SystemMedicrea International SA · 2019

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−20K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−18K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−17K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−15K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−13K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−12K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−11K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−10K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−9K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−8K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−7K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−6K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−5K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−4K142381Xia 3 Spinal SystemStryker Corp.2014—
−3K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
−2K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation20171
−1K182240PASS LP Spinal SystemMedicrea International SA2018—
0 (this device)K190376PASS LP Spinal SystemMedicrea International SA2019—
+1K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199340
199440
199590
1996100
199790
1998170
1999120
2000250
2001320
2002240
2003220
2004280
2005240
2006240
2007210
2008240
2009180
2010251
2011140
201270
201360
201420
201520
201610
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K190376, 2004–2022Source: 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.

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? (5)

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
*K124058Creo Stabilization System
Summary page 4
…l fixation orthosis KWP 888.3050 Regulatory Class: II Product Code: NKB, KWP c. PREDICATE DEVICE Primary Predicate device is: CREO™ Stabilization System, K124058 Additional predicate devices are: • PASS LP Spinal System, K182240 • TSRH Spinal Syst…
Globus Medical, Inc.2013—
*K182240PASS LP Spinal System
Summary page 4
…c. PREDICATE DEVICE Primary Predicate device is: CREO™ Stabilization System, K124058 Additional predicate devices are: • PASS LP Spinal System, K182240 • TSRH Spinal System, K010720 • Titanium MOSS MIAMI Spinal System, K955348…
Medicrea International SA2018—
*K010720TSRH Spinal System
Summary page 4
…CREO™ Stabilization System, K124058 Additional predicate devices are: • PASS LP Spinal System, K182240 • TSRH Spinal System, K010720 • Titanium MOSS MIAMI Spinal System, K955348 • PASSmed Spinal System, K070530 Those…
Medtronic Sofamor Danek, Inc.2001—
*K955348Titanium Moss Miami Spinal System
Summary page 4
…re: • PASS LP Spinal System, K182240 • TSRH Spinal System, K010720 • Titanium MOSS MIAMI Spinal System, K955348 • PASSmed Spinal System, K070530 Those devices have not been subject to a design-related recall.…
Depuy, Inc.1996—
*K070530Modification to Passmed Spinal System
Summary page 4
…240 • TSRH Spinal System, K010720 • Titanium MOSS MIAMI Spinal System, K955348 • PASSmed Spinal System, K070530 Those devices have not been subject to a design-related recall.…
Medicrea Technologies2007—

Also cleared against K124058: 14 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 28, 2020Class IIZ-1473-2020Process controlAn internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Jan 28, 2020Class IIZ-1472-2020Process controlAn internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw insertion, or during the reduction step.
Nov 11, 2019Class IIZ-1234-2020Device DesignIncompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
Sep 16, 2019Class IIZ-0827-2020Process controlConical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Sep 16, 2019Class IIZ-0828-2020Process controlConical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

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 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 7 companies; a new generation was cleared every 6 months on median.
  • 38 of the 395 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K213281 (Medicrea International SA, 2022) has gone furthest, with 0 descendants of its own.
  • 14 other devices also cite its predicate K124058.

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 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 (172 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 and caps for sacral 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 K124058

14 other devices cite the same predicate.

  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025
  • K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp · 2024
  • K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023
  • K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
  • K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc. · 2021

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/K190376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190376: 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/K190376

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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