510(k) Report

510(k) · Cleared

Cleared

MOSS VRS Spinal System

K203607510(k) TraditionalCleared Aug 20, 2021253-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

Biedermann Motech GmbH & Co. KG · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Aug 20, 2021 as substantially equivalent to K181821 (Biedermann Motech GmbH & Co. KG, 2018) and 6 other predicates after a 253-day review. Its family tree reaches back 18 generations to 2004. 1 of the 291 devices in its family, counting itself, has a Class I recall.

Decided
Aug 20, 2021
Review
253 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 18 generations to K040583 (2004). 290 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 1 of the 291 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 2018: 1 other ancestor2016: 1 other ancestor2013: 3 other ancestors2012: 4 other ancestors1999: 14 other ancestors2011: 7 other ancestors2010: 9 other ancestors, 1 with a Class I recall12009: 11 other ancestors2008: 13 other ancestors2006: 15 other ancestors2004: 26 other ancestors2003: 19 other ancestors2001: 18 other ancestors2000: 19 other ancestors1997: 8 other ancestors2014: 2 other ancestors2007: 14 other ancestors2005: 20 other ancestors2002: 18 other ancestors1998: 15 other ancestors1996: 10 other ancestors1995: 9 other ancestors1994: 3 other ancestors1993: 3 other ancestors1984: 1 other ancestor1992: 5 other ancestors1990: 2 other ancestors1978: 1 other ancestor1985: 1 other ancestor×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. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 201619801990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 23 other ancestors, 1 with a Class I recall13 generations back: 43 other ancestors4 generations back: 70 other ancestors5 generations back: 54 other ancestors6 generations back: 44 other ancestors7 generations back: 16 other ancestors8 generations back: 9 other ancestors9 generations back: 7 other ancestors K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 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 · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  4. 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  5. 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  6. This deviceK203607 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 4 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 3 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 2 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 1 generation backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. This deviceK203607 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System2 generations back · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−2K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−1K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
0 (this device)K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199430
199590
1996100
199780
1998150
1999140
2000190
2001180
2002180
2003190
2004260
2005200
2006150
2007140
2008130
2009110
201091
201170
201240
201330
201420
201610
201810
FIG. 1 — Lineage of K203607, 2004–2021Source: 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
*K181821MOSS VRS Spinal System
Summary page 5
…Page 2 of 4 Predicate Devices Primary MOSS VRS Spinal System, Biedermann Motech GmbH Predicate: & Co. KG (K181821) Additional EXPEDIUM Spine System, DePuy Spine, Inc. Predicates: (K131802)…
Biedermann Motech GmbH & Co. KG2018—
*K131802Expedium, Viper. Viper 2 Spine System
Summary page 5
…stem, Biedermann Motech GmbH Predicate: & Co. KG (K181821) Additional EXPEDIUM Spine System, DePuy Spine, Inc. Predicates: (K131802) Nuvasive® GSB Global Spinal Balance System, Nuvasive Inc. (K132014)…
Depuy Spine, A Johnson & Johnson Company2013—
*K132014GSB Global Spinal Balance System
Summary page 5
…Spine System, DePuy Spine, Inc. Predicates: (K131802) Nuvasive® GSB Global Spinal Balance System, Nuvasive Inc. (K132014) Nuvasive® Reline® System, Nuvasive Inc. (K160989) MOSS 100 Spinal System, Biederma…
Nuvasive, Inc.2013—
*K160989NuVasive® Reline® System
Summary page 5
…Nuvasive® GSB Global Spinal Balance System, Nuvasive Inc. (K132014) Nuvasive® Reline® System, Nuvasive Inc. (K160989) MOSS 100 Spinal System, Biedermann Motech GmbH & Co. KG (K162232)…
Nu Vasive, Incorporated2016—
*K162232MOSS 100 Pedicle Screw System
Summary page 5
…Nuvasive® Reline® System, Nuvasive Inc. (K160989) MOSS 100 Spinal System, Biedermann Motech GmbH & Co. KG (K162232) Synthes MATRIX System, Synthes Spine (K120838) Synthes Universal Spinal System, Sy…
Biedermann Motech GmbH & Co. KG2016—
*K120838Synthes Matrix System
Summary page 5
…MOSS 100 Spinal System, Biedermann Motech GmbH & Co. KG (K162232) Synthes MATRIX System, Synthes Spine (K120838) Synthes Universal Spinal System, Synthes Spine (K990745) Device Description The…
Synthes Spine2012—
*K990745Modification to Synthes Universal Spinal System
Summary page 5
…2232) Synthes MATRIX System, Synthes Spine (K120838) Synthes Universal Spinal System, Synthes Spine (K990745) Device Description The Biedermann Motech MOSS VRS Spinal System is a comprehensive thoracolumbosacral spinal system that offer…
Synthes Spine1999—

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

What does this lineage say?

  • The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 6 months on median.
  • 36 of the 290 ancestors have a recall of any class; 1 has a Class I recall.

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. 2021, 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 MOSS VRS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: - degenerative disc disease (DDD is defined as back pain of discogenic origin…

Read the full statement (158 words)

The MOSS VRS Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The MOSS VRS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications:

- degenerative disc disease (DDD is 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 and/or lordosis)

-tumor

- pseudoarthrosis

- failed previous fusion

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the MOSS VRS System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The MOSS VRS 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.

More from Biedermann Motech GmbH & Co. KG

4 FDA decisions under this applicant name. See the company

  • K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018
  • K170890TELIX K Interbody SystemBiedermann Motech GmbH & Co. KG · 2017
  • K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG · 2016

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/K203607 · printed Nov 4, 2026

Cite this page

510(k) Report. “K203607: MOSS VRS Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203607

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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