510(k) · Cleared
ClearedMOSS 100 Pedicle Screw 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 Nov 17, 2016 as substantially equivalent to K041119 (Depuy Spine, Inc., 2004) after a 101-day review. Its family tree reaches back 2 generations to 2004. 2 later devices descend from it.
- Decided
- Nov 17, 2016
- Review
- 101 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033901 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK033901 Merlin Spine SystemDepuy Spine, Inc. · 2004
- 1 generation backK041119 Expedium Spine SystemDepuy Spine, Inc. · 2004
- This deviceK162232 MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG · 2016
- Descendant · cites it directly · 1 of its ownK181821 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
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033901 | Merlin Spine System | Depuy Spine, Inc. | 2004 | — |
| −1 | K041119 | Expedium Spine System | Depuy Spine, Inc. | 2004 | — |
| 0 (this device) | K162232 | MOSS 100 Pedicle Screw System | Biedermann Motech GmbH & Co. KG | 2016 | — |
| +1 | K181821 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2018 | — |
| +1 | K203607 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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.
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 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? (1)
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 |
|---|---|---|---|
| * | K041119 | Expedium Spine SystemSummary page 5…K162232 - Page 2 of 4 Biedermann Motech GmbH & Co.KG MOSS 100 Pedicle Screw System K162232 3. Primary Predicate Device K041119 Expedium Spine System, DePuy Spine, Inc. 4. Reference Device K092929 Synthes Matri… | 2004 |
| † | K092929 | Synthes Matrix System | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2 companies; a new generation was cleared every 12.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181821 (Biedermann Motech GmbH & Co. KG, 2018) has gone furthest, with 1 descendant of its own.
- 28 other devices also cite its predicate K041119.
How does its category compare?
All NKB devicesNKB 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
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 100 Pedicle Screw System is a thoracolumbar pedicle fixation device for the following indications of use:
- 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, kyphoses and/ or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
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/K162232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162232: MOSS 100 Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162232
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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