510(k) · Cleared
ClearedVIPER PRIME™ additions to the VIPER® System
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 Dec 8, 2016 as substantially equivalent to K160904 (Medos International SARL, 2016) after a 52-day review. Its family tree reaches back 2 generations to 2012. 49 later devices descend from it.
- Decided
- Dec 8, 2016
- Review
- 52 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K111136 (2012). 49 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK111136 Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 2012 · Recalled
- 1 generation backK160904 Expedium Spine System, VIPER and VIPER 2 SystemsMedos International SARL · 2016
- This deviceK162912 VIPER PRIME™ additions to the VIPER® SystemMedos International SARL · 2016
- Descendant · cites it directly · 48 of its ownK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- Descendant · 2 generations on · 41 of its ownK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 3 generations on · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 4 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 3 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K170543VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017 · cites it directly48descendants
- K173487CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 2 generations on41descendants
- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · 3 generations on39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 4 generations on29descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K111136 | Expedium Spine System, Viper System, Viper 2 System | Depuy Spine, Inc. | 2012 | 1 |
| −1 | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | Medos International SARL | 2016 | — |
| 0 (this device) | K162912 | VIPER PRIME™ additions to the VIPER® System | Medos International SARL | 2016 | — |
| +1 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| +2 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +3 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +4 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | K160904 | Expedium Spine System, VIPER and VIPER 2 SystemsSummary page 5…K162912 - Page 2 of 3 D. Predicate Device Name Primary Predicate Device: EXPEDIUM and VIPER Spine Systems (K160904) E. Device Description The VIPER System (including VIPER2) is intended to provide immobilization and stabilization… | 2016 |
What descends from it? (49)
See all 495 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170543 | VIPER PRIME™ Screws with Fenestrations | 2017 | 48 |
| K171570 | Additional VIPER PRIME™ screws with fenestrations | 2017 | 20 |
| K173095 | VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with… | 2017 | 19 |
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X… | 2023 | 4 |
| 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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K170543 (Medos International SARL, 2017) has gone furthest, with 48 descendants of its own.
- 4 other devices also cite its predicate K160904.
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 and VIPER Spine 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 and VIPER Spine Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back…
Read the full statement (233 words)
The EXPEDIUM and VIPER Spine 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 and VIPER Spine 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 System is 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 and VIPER Spine
System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and
VIPER Spine Systems are 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.
https://510kreport.com/device/K162912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162912: VIPER PRIME™ additions to the VIPER® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162912
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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