510(k) · Cleared
ClearedExpedium, Viper. Viper 2 Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, A Johnson & Johnson Company · OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Cleared on Sep 12, 2013 as substantially equivalent to K041205 (Depuy Spine, Inc., 2004) and 2 other predicates after an 85-day review. Its family tree reaches back 13 generations to 1985. 139 later devices descend from it.
- Decided
- Sep 12, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- OSH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K853033 (1985). 75 ancestors in all. 139 later devices descend from it, 14 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 deviceK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
- Descendant · cites it directly · 70 of its ownK181677 Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
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 deviceK131802 Expedium, Viper. Viper 2 Spine SystemDepuy Spine, A Johnson & Johnson Company · 2013
Showing 5 of 139 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 139 · See all- K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc. · 2018 · cites it directly70descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 2 generations on69descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 2 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 3 generations on59descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
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) | K131802 | Expedium, Viper. Viper 2 Spine System | Depuy Spine, A Johnson & Johnson Company | 2013 | — |
| +1 | K181677 | Kodiak Spinal Fixation System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 24 | 0 |
| 2024 | 22 | 0 |
| 2025 | 23 | 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 OSH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K041205 | Expedium Anterior Spine SystemSummary page 2…K131802 ::page 2 of 3 D. Predicate Device Name Trade name: EXPEDIUM® Anterior Spine System (K(041205) EXPEDIUM® Spine System (K(101993) EXPEDIUM® and VIPER' and VIPER®2 Spine Systems (K(1111… | 2004 |
| * | K101993 | Viper System, Expedium SystemSummary page 2…K131802 ::page 2 of 3 D. Predicate Device Name Trade name: EXPEDIUM® Anterior Spine System (K(041205) EXPEDIUM® Spine System (K(101993) EXPEDIUM® and VIPER' and VIPER®2 Spine Systems (K(111136) E. Device Description The EXPEDIUMO and V… | 2010 |
| * | K111136 | Expedium Spine System, Viper System, Viper 2 SystemSummary page 3…ormance and Intended Use The proposed modifications to the EXPEDIUM, VIPER and VIPER2 Systems are identical to the predicate devices (K111136) except for the proposed devices will be terminally sterilized via gamma radiation. The design, materials, indicati… | 2012 |
What descends from it? (139)
See all 13914 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181677 | Kodiak Spinal Fixation System | 2018 | 70 |
| K150417 | Astra Spine System | 2015 | 21 |
| K143200 | MIS Z-Pedicle Screw System | 2015 | 14 |
| K181139 | OLYMPIC Posterior Spinal Fixation System | 2018 | 8 |
| K171421 | VERTICALE® Posterior Spinal Fixation System/VERTICALE® System | 2018 | 6 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | 2021 | 5 |
| K151648 | Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle… | 2015 | 5 |
| K161387 | Mont Blanc and Mont Blanc MIS Spinal Systems | 2016 | 3 |
| K181821 | MOSS VRS Spinal System | 2018 | 1 |
| K203607 | MOSS VRS Spinal System | 2021 | 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 28 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 75 ancestors have a recall of any class.
- Of its descendants, K181677 (Alphatec Spine, Inc., 2018) has gone furthest, with 70 descendants of its own.
How does its category compare?
All OSH devicesOSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OSH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OSH
82in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OSH
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OSH
3in 2025
MAUDE reports naming product code OSH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 3 | 76 | 0 | 1 |
| 2013 | 14 | 82 | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 1 | 4 |
| 2018 | 0 | — | 0 | 14 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 12 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EXPEDIUM, VIPER, and 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, VIPER, and VIPER2 Spine System is intended for noncervical pedlicle fixation and nonpedicle fixation for the following indications: degenerative disc disease…
Read the full statement (233 words)
The EXPEDIUM, VIPER, and 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, VIPER, and VIPER2 Spine System is intended for noncervical pedlicle 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 lordlosis); 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, pseudloarthrosis; and failed previous fusion 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 as stated in the FDA summary.
https://510kreport.com/device/K131802 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131802: Expedium, Viper. Viper 2 Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131802
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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