510(k) · Decided
Recalled · Class II · 2015Expedium Spine System, Viper System, Viper 2 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 14, 2012 after a 419-day review. The FDA summary names no predicate by number. 1 of the 305 devices in its family, counting itself, has a Class I recall. 304 later devices descend from it. It has been recalled once.
- Decided
- Jun 14, 2012
- Review
- 419 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 0
304 later devices descend from it, 15 citing it directly. 1 of the 305 devices in this family, counting this one, has a Class I recall.
- This deviceK111136 Expedium Spine System, Viper System, Viper 2 SystemDepuy Spine, Inc. · 2012
- Descendant · cites it directly · 172 of its ownK124058 Creo Stabilization SystemGlobus Medical, Inc. · 2013
- Descendant · 2 generations on · 158 of its ownK143633 CREO Stabilization SystemGlobus Medical, Inc. · 2015
- Descendant · cites it directly · 139 of its ownK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 88 of its ownK180210 CREO® Stabilization SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 74 of its ownK160904 Expedium Spine System, VIPER and VIPER 2 SystemsMedos International SARL · 2016
Showing 5 of 304 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 304 · See all- K124058Creo Stabilization SystemGlobus Medical, Inc. · 2013 · cites it directly172descendants
- K143633CREO Stabilization SystemGlobus Medical, Inc. · 2015 · 2 generations on158descendants
- K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013 · cites it directly139descendants
- K180210CREO® Stabilization SystemGlobus Medical, Inc. · 2018 · 2 generations on88descendants
- K160904Expedium Spine System, VIPER and VIPER 2 SystemsMedos International SARL · 2016 · cites it directly74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111136 | Expedium Spine System, Viper System, Viper 2 System | Depuy Spine, Inc. | 2012 | — |
| +1 | K124058 | Creo Stabilization System | Globus Medical, Inc. | 2013 | — |
| +2 | K143633 | CREO Stabilization System | Globus Medical, Inc. | 2015 | — |
| +1 | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| +2 | K180210 | CREO® Stabilization System | Globus Medical, Inc. | 2018 | — |
| +1 | K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | Medos International SARL | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 5 | 0 |
| 2014 | 10 | 0 |
| 2015 | 12 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 20 | 0 |
| 2021 | 17 | 1 |
| 2022 | 27 | 0 |
| 2023 | 40 | 0 |
| 2024 | 48 | 0 |
| 2025 | 40 | 0 |
| 2026 | 34 | 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?
The FDA summary names no predicate by number.
What descends from it? (304)
See all 30415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K124058 | Creo Stabilization System | 2013 | 172 |
| K131802 | Expedium, Viper. Viper 2 Spine System | 2013 | 139 |
| K160904 | Expedium Spine System, VIPER and VIPER 2 Systems | 2016 | 74 |
| K122877 | Range Spinal System, Small Stature | 2013 | 34 |
| K142185 | Expedium Verse Spine System | 2014 | 20 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K130877 | Expedium Spine System | 2013 | 8 |
| K190471 | 4CIS® Chiron Spinal Fixation System | 2019 | 6 |
| K141509 | Isola and Expedium Growing Spine Systems | 2014 | 6 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | 2021 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2015 | Class II | Z-1674-2015 | Process design | Device does not mate as intended. |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K124058 (Globus Medical, Inc., 2013) has gone furthest, with 172 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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/VIPER2 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/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications…
Read the full statement (268 words)
The EXPEDIUM and VIPER/VIPER2 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/VIPER2 Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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/VIPER2 System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion 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.
The EXPEDIUM and VIPER/VIPER2 PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade T spondylolisthesis) from L1-S! in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM and VIPER/VIPER2 System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM and VIPER/VIPER2 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/K111136 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111136: Expedium Spine System, Viper System, Viper 2 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111136
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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