510(k) Report

510(k) · Cleared

Cleared

PASS LP™ Spinal System, CD Horizon™ Spinal System

K213281510(k) TraditionalCleared Jan 5, 202296-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 Jan 5, 2022 as substantially equivalent to K080099 (Medicrea Technologies, 2008) and 6 other predicates after a 96-day review. Its family tree reaches back 21 generations to 2004. 1 of the 475 devices in its family, counting itself, has a Class I recall.

Decided
Jan 5, 2022
Review
96 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 21 generations to K040583 (2004). 474 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 475 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2020: 2 other ancestors2015: 6 other ancestors2014: 7 other ancestors2008: 27 other ancestors2013: 10 other ancestors2011: 15 other ancestors2010: 25 other ancestors, 1 with a Class I recall12007: 21 other ancestors2004: 30 other ancestors2003: 24 other ancestors2001: 35 other ancestors1996: 11 other ancestors2017: 2 other ancestors2012: 9 other ancestors2009: 18 other ancestors2006: 27 other ancestors2005: 28 other ancestors2002: 27 other ancestors2000: 30 other ancestors1999: 14 other ancestors2016: 1 other ancestor1998: 21 other ancestors1997: 14 other ancestors1995: 16 other ancestors1978: 1 other ancestor1994: 8 other ancestors1993: 4 other ancestors1984: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1992: 7 other ancestors1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors1990: 3 other ancestors×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 · 2018K190376 · PASS LP Spinal System · Medicrea International SA · 2019 · recalled19801990200020102020
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 13 other ancestors3 generations back: 44 other ancestors, 1 with a Class I recall14 generations back: 82 other ancestors5 generations back: 96 other ancestors6 generations back: 85 other ancestors7 generations back: 53 other ancestors8 generations back: 28 other ancestors9 generations back: 36 other ancestors10 generations back: 5 other ancestors11 generations back: 6 other ancestors K190376 · PASS LP Spinal System · Medicrea International SA · 2019 · recalledK182240 · 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 · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  4. 2 generations backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
  5. 1 generation backK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
  6. This deviceK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 7 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 6 generations backK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
  17. 5 generations backK142381 Xia 3 Spinal SystemStryker Corp. · 2014
  18. 4 generations backK152632 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation · 2015
  19. 3 generations backK170496 Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation · 2017 · Recalled
  20. 2 generations backK182240 PASS LP Spinal SystemMedicrea International SA · 2018
  21. 1 generation backK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
  22. This deviceK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022

Class I recalls in this family

View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−7K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−6K140276CD Horizon Spinal SystemMedtronic Sofamor Danek2014—
−5K142381Xia 3 Spinal SystemStryker Corp.2014—
−4K152632XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument AccessoryStryker Corporation2015—
−3K170496Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument AccessoryStryker Corporation20171
−2K182240PASS LP Spinal SystemMedicrea International SA2018—
−1K190376PASS LP Spinal SystemMedicrea International SA20195
0 (this device)K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199270
199340
199480
1995160
1996110
1997140
1998210
1999140
2000300
2001350
2002270
2003240
2004300
2005280
2006270
2007210
2008270
2009180
2010251
2011150
201290
2013100
201470
201560
201610
201720
202020
FIG. 1 — Lineage of K213281, 2004–2022Source: 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? (7)

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
*K080099Pass Spinal System
Summary page 6
…Class II 3. Predicate or legally marketed devices which are substantially equivalent: Primary predicate for PASS LP™ Spinal System: • PASS LP™ Spinal System (K080099, S.E. 09/04/2008) Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021)…
Medicrea Technologies2008—
*K202771CD Horizon Spinal System
Summary page 6
…te for PASS LP™ Spinal System: • PASS LP™ Spinal System (K080099, S.E. 09/04/2008) Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal Sy…
Medtronic2020—
*K141398Pass LP Spinal System
Summary page 6
…Primary predicate for CD Horizon™ Spinal System • CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014)…
Medicrea International SA20151
*K190376PASS LP Spinal System
Summary page 6
…CD Horizon™ Spinal System (K202771, S.E. 10/19/2021) Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015…
Medicrea International SA20195
*K140738Pass LP Spinal System
Summary page 6
…Additional predicate device: • PASS LP™ Spinal System (K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2…
Medicrea International2014—
*K150178CD Horizon Spinal System
Summary page 6
…(K141398, S.E. 01/09/2015) • PASS LP™ Spinal System (K190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2013) The predicates have not been subject to a design…
Medtronic Sofamor Danek USA, Inc.2015—
*K132471CD Horizon Spinal System
Summary page 6
…190376, S.E. 05/02/2019) • PASS LP™ Spinal System (K140738, S.E. 11/04/2014) • CD Horizon™ Spinal System (K150178, S.E. 02/11/2015) • CD Horizon™ Spinal System (K132471, S.E. 10/08/2013) The predicates have not been subject to a design related recall. 4. Description of the device: === Page 7…
Medtronic Sofamor Danek USA, Inc.2013—

Also cleared against K080099: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

What does this lineage say?

  • The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 6 months on median.
  • 49 of the 474 ancestors have a recall of any class; 1 has a Class I recall.
  • 4 other devices also cite its predicate K080099.

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. 2022, 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 (586 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.

The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.

With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. Devices are intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.

The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD, spondylolisthesis, trauma, and/or tumor.

To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of Vertex™ indications.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K213281: PASS LP™ Spinal System, CD Horizon™ 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/K213281

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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