510(k) · Cleared
Recalled · Class II · 2012Viper System, Expedium 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 Dec 7, 2010 as substantially equivalent to K033901 (Depuy Spine, Inc., 2004) and 5 other predicates after a 145-day review. Its family tree reaches back 12 generations to 1985. 162 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 7, 2010
- Review
- 145 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 8
- Predicates
- 6
Its longest line of descent runs back 12 generations to K853033 (1985). 68 ancestors in all. 162 later devices descend from it, 6 citing it directly.
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 8 generations between
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 139 of its ownK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- Descendant · 2 generations on · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 4 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Show all 12 generations
- Root · 12 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 10 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 9 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 8 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 7 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 6 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 5 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 3 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 2 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 1 generation backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- This deviceK101993 Viper System, Expedium SystemDepuy Spine, Inc. · 2010
Showing 5 of 162 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 162 · See all- K131802Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013 · cites it directly139descendants
- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · 2 generations on70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 4 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −11 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −10 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −9 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −8 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −7 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −6 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −5 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −3 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −2 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −1 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K101993 | Viper System, Expedium System | Depuy Spine, Inc. | 2010 | — |
| +1 | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| +2 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 25 | 0 |
| 2024 | 24 | 0 |
| 2025 | 24 | 0 |
| 2026 | 20 | 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? (6)
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 1…: 87 Product Code(s): NKB, KWQ, KWP, MM-I, MNI Proprietary Name: EXPEDIUM® Spine System; VIPER® System Predicate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741,… | 2004 |
| * | K090648 | Viper 2 SystemSummary page 1…Product Code(s): NKB, KWQ, KWP, MM-I, MNI Proprietary Name: EXPEDIUM® Spine System; VIPER® System Predicate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741, K080313)… | 2009 |
| * | K051024 | Expedium Spine SystemSummary page 1…me: EXPEDIUM® Spine System; VIPER® System Predicate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741, K080313) Device Description: The subject EXPEDIUM and VIPER Spine System c… | 2005 |
| * | K063156 | Modification to Expedium Spine SystemSummary page 1…PEDIUM® Spine System; VIPER® System Predicate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741, K080313) Device Description: The subject EXPEDIUM and VIPER Spine System components… | 2006 |
| * | K063741 | Expedium Spine SystemSummary page 1…Predicate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741, K080313) Device Description: The subject EXPEDIUM and VIPER Spine System components consist of… | 2007 |
| * | K080313 | Modification to Expedium Spine SystemSummary page 1…icate Devices: VIPER@ System (K033901, K090648) EXPEDIUJM® Spine System (K033901, K05 1024, K063 156, K063741, K080313) Device Description: The subject EXPEDIUM and VIPER Spine System components consist of screws an… | 2008 |
What descends from it? (162)
See all 1626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131802 | Expedium, Viper. Viper 2 Spine System | 2013 | 139 |
| K133369 | Tiger Spine System | 2014 | 29 |
| K110216 | Expedium System, Viper System | 2011 | 4 |
| K162995 | Ibis® Pedicle Screw System | 2017 | 3 |
| K121130 | Polaris Spinal System-Ballista Spinal Rods | 2012 | 1 |
| K191212 | CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated… | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2012 | Class II | Z-0705-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0707-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0706-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0708-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0709-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0710-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0712-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head |
| Nov 7, 2012 | Class II | Z-0713-2013 | Component change control | Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 68 ancestors have a recall of any class.
- Of its descendants, K131802 (Depuy Spine, A Johnson & Johnson Company, 2013) has gone furthest, with 139 descendants 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. 2010, 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/K101993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101993: Viper System, Expedium System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101993
Report an extraction error
Are you the manufacturer?
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