510(k) · Cleared
ClearedExpedium System, Viper 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 Apr 1, 2011 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 8 other predicates after a 66-day review. Its family tree reaches back 13 generations to 1985. 4 later devices descend from it.
- Decided
- Apr 1, 2011
- Review
- 66 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 13 generations to K853033 (1985). 73 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- This deviceK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK121130 Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012
- Descendant · cites it directly · 0 of its ownK191212 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System…Medos International SARL · 2019
- Descendant · 2 generations on · 0 of its ownK123451 Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · cites it directly · 0 of its ownK120928 Synthes Matrix SystemSynthes Spine · 2012
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 1 generation backK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010 · Recalled
- This deviceK110216 Expedium System, Viper SystemDepuy Spine, Inc. · 2011
Most influential descendants
Showing 4 of 4 · See all- K121130Polaris Spinal System-Ballista Spinal RodsBiomet Spine · 2012 · cites it directly1descendant
- K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL · 2019 · cites it directly0descendants
- K123451Polaris Spinal System - Ballista II RodsBiomet Spine (Aka Ebi, LLC) · 2012 · 2 generations on0descendants
- K120928Synthes Matrix SystemSynthes Spine · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −2 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −1 | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | 8 |
| 0 (this device) | K110216 | Expedium System, Viper System | Depuy Spine, Inc. | 2011 | — |
| +1 | K121130 | Polaris Spinal System-Ballista Spinal Rods | Biomet Spine | 2012 | — |
| +1 | K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM… | Medos International SARL | 2019 | — |
| +2 | K123451 | Polaris Spinal System - Ballista II Rods | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +1 | K120928 | Synthes Matrix System | Synthes Spine | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2019 | 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? (9)
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 |
|---|---|---|---|
| * | K033901 | Merlin Spine SystemSummary page 2…CFR §888.3070 DePu~y Spine, Inc., a Johnson & Johnson Company Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K… | 2004 |
| * | K051024 | Expedium Spine SystemSummary page 2…70 DePu~y Spine, Inc., a Johnson & Johnson Company Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K1… | 2005 |
| * | K062174 | Modification to Expedium Spine SystemSummary page 2…ePu~y Spine, Inc., a Johnson & Johnson Company Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 De… | 2006 |
| * | K063156 | Modification to Expedium Spine SystemSummary page 2…e, Inc., a Johnson & Johnson Company Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Descr… | 2006 |
| * | K063741 | Expedium Spine SystemSummary page 2…Johnson & Johnson Company Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Description:… | 2007 |
| * | K080313 | Modification to Expedium Spine SystemSummary page 2…Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Description: The proposed conical fix polyax… | 2008 |
| * | K081898 | Expedium Spine SystemSummary page 2…Page 21 Predicate Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Description: The proposed conical fix polyaxial screws… | 2008 |
| * | K090648 | Viper 2 SystemSummary page 2…e Devices: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Description: The proposed conical fix polyaxial screws for EXPEDIUM and VIPER System ar… | 2009 |
| * | K101993 | Viper System, Expedium SystemSummary page 2…: EXPEDIUM® System - K03390 1, KO051024, K0621 74, K063 156, K063741, K0803 13, K08 1898 VIPER® System - K033901, K090648, K101993 Device Description: The proposed conical fix polyaxial screws for EXPEDIUM and VIPER System are availab… | 2010 |
What descends from it? (4)
3 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 26 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 73 ancestors have a recall of any class.
- Of its descendants, K121130 (Biomet Spine, 2012) has gone furthest, with 1 descendant of its own.
- 34 other devices also cite its predicate K033901.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of…
Read the full statement (174 words)
The EXPEDIUM and VIPER 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 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous approach with MIS Instrumentation, the VIPER 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110216: Expedium System, Viper System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110216
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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