510(k) · Cleared
ClearedExpedium Spine System, VIPER and VIPER 2 Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medos International SARL · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 1, 2016 as substantially equivalent to K111136 (Depuy Spine, Inc., 2012) after a 91-day review. Its family tree reaches back 1 generation to 2012. 74 later devices descend from it.
- Decided
- Jul 1, 2016
- Review
- 91 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111136 (2012). 74 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK111136 Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 2012 · Recalled
- This deviceK160904 Expedium Spine System, VIPER and VIPER 2 SystemsMedos International SARL · 2016
- Descendant · cites it directly · 49 of its ownK162912 VIPER PRIME™ additions to the VIPER® SystemMedos International SARL · 2016
- Descendant · 2 generations on · 48 of its ownK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- Descendant · 3 generations on · 41 of its ownK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 4 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 5 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL · 2016 · cites it directly49descendants
- K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017 · 2 generations on48descendants
- K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 3 generations on41descendants
- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 4 generations on39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 5 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111136 | Expedium Spine System, Viper System, Viper 2 System | Depuy Spine, Inc. | 2012 | 1 |
| 0 (this device) | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | Medos International SARL | 2016 | — |
| +1 | K162912 | VIPER PRIME™ additions to the VIPER® System | Medos International SARL | 2016 | — |
| +2 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| +3 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +4 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +5 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 6 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K111136 | Expedium Spine System, Viper System, Viper 2 SystemSummary page 5…K160904 - page 2 of 3 E. Predicate Device Name Primary Predicate: EXPEDIUM Spine System and VIPER and VIPER 2 Systems (K111136) Reference Predicates: EXPEDIUM Spine System, VIPER and VIPER2 Systems (K131802) EX… | 2012 |
| † | K131802 | Expedium, Viper. Viper 2 Spine System | 2013 |
| † | K130877 | Expedium Spine System | 2013 |
| † | K121020 | Viper System | 2012 |
| † | K110216 | Expedium System, Viper System | 2011 |
| † | K103490 | Expedium Spine System, Moss Miami Spine System | 2011 |
What descends from it? (74)
See all 745 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162912 | VIPER PRIME™ additions to the VIPER® System | 2016 | 49 |
| K211323 | ASTRA Spine System | 2021 | 12 |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | 2020 | 12 |
| K231479 | TriALTIS Spine System | 2023 | 8 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
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?
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 EXPEDIUM Spine System and VIPER and VIPER 2 Systems are 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 EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications…
Read the full statement (252 words)
The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are 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 EXPEDIUM Spine System and VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; and failed previous fusion in skeletally mature patients.
When used in a posterior percutaneous approach with MIS instrumentation, the VIPER and VIPER 2 Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (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; and failed previous fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM Spine System and VIPER and VIPER 2 Systems metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM Spine System and VIPER and VIPER 2 Systems are 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/K160904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160904: Expedium Spine System, VIPER and VIPER 2 Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160904
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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