510(k) · Cleared
ClearedMOSS VRS Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biedermann Motech GmbH & Co. KG · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 13, 2018 as substantially equivalent to K131802 (Depuy Spine, A Johnson & Johnson Company, 2013) and 2 other predicates after a 66-day review. Its family tree reaches back 14 generations to 1985. 1 of the 232 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 13, 2018
- Review
- 66 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K853033 (1985). 230 ancestors in all, the oldest K781443 (1978). 1 later device descends from it, 1 citing it directly. 1 of the 232 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- This deviceK181821 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018
- Descendant · cites it directly · 0 of its ownK203607 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- 1 generation backK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- This deviceK181821 MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2018
Class I recalls in this family
- K100952 Modification to Synthes Matrix System2 generations back · 2010
Most influential descendants
Showing 1 of 1 · See all- K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
| −1 | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| 0 (this device) | K181821 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2018 | — |
| +1 | K203607 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 13 | 0 |
| 2000 | 13 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 21 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 1 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K131802 | Expedium, Viper. Viper 2 Spine SystemSummary page 5…5 === K181821 - Page 2 of 4 3. PredicateDevice PredicateDevice: EXPEDIUMSpineSystem,DePuySpine,Inc.(K131802) AdditionalPredicates: SynthesMATRIXSystem,SynthesSpine(K120838) MOSS100SpinalSystem,Biederm… | 2013 |
| * | K120838 | Synthes Matrix SystemSummary page 5…of 4 3. PredicateDevice PredicateDevice: EXPEDIUMSpineSystem,DePuySpine,Inc.(K131802) AdditionalPredicates: SynthesMATRIXSystem,SynthesSpine(K120838) MOSS100SpinalSystem,BiedermannMotech(K162232) 4. DeviceDescription 5. Material 6. Indic… | 2012 |
| * | K162232 | MOSS 100 Pedicle Screw SystemSummary page 5…,DePuySpine,Inc.(K131802) AdditionalPredicates: SynthesMATRIXSystem,SynthesSpine(K120838) MOSS100SpinalSystem,BiedermannMotech(K162232) 4. DeviceDescription 5. Material 6. IndicationsforUse Ͳ Ͳ Ͳ… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203607 | MOSS VRS Spinal System | 2021 | 0 |
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 33 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 27 of the 230 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203607 (Biedermann Motech GmbH & Co. KG, 2021) has gone furthest, with 0 descendants of its own.
- 13 other devices also cite its predicate K131802.
How does its category compare?
All NKB devicesNKB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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) (defined as back pain of discogenic origin…
Read the full statement (157 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) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fractures or dislocations)
- 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181821: MOSS VRS 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/K181821
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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