510(k) · Cleared
ClearedScient'x Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scient'X · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 5, 2007 as substantially equivalent to K051063 (Scient'X, 2005) and 5 other predicates after a 131-day review. Its family tree reaches back 7 generations to 1990. 36 later devices descend from it.
- Decided
- Feb 5, 2007
- Review
- 131 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K901587 (1990). 45 ancestors in all. 36 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- 3 generations backK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- 2 generations backK020245 Modification to Isobar Spinal SystemScien'Tx USA, Inc. · 2002
- 1 generation backK042964 MX Monoaxial Pedicle ScrewScient'X · 2004
- This deviceK062912 Scient'x Spinal SystemScient'X · 2007
- Descendant · cites it directly · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 2 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
- Descendant · 3 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 4 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
- Descendant · 5 generations on · 5 of its ownK231199 Solar Lumbar Interbody Fusion SystemDegen Medical · 2023
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K133369Tiger Spine SystemCorelink, LLC · 2014 · cites it directly29descendants
- K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 2 generations on17descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 3 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 4 generations on12descendants
- K231199Solar Lumbar Interbody Fusion SystemDegen Medical · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| −3 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| −2 | K020245 | Modification to Isobar Spinal System | Scien'Tx USA, Inc. | 2002 | — |
| −1 | K042964 | MX Monoaxial Pedicle Screw | Scient'X | 2004 | — |
| 0 (this device) | K062912 | Scient'x Spinal System | Scient'X | 2007 | — |
| +1 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +2 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
| +3 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +4 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
| +5 | K231199 | Solar Lumbar Interbody Fusion System | Degen Medical | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 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 MNI? 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? (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 |
|---|---|---|---|
| * | K051063 | Polyaxial Hemispherical Spinal ScrewsSummary page 1…3. Predicate or legally marketed devices which are substantially equivalent: · Scient'x previously cleared devices: o Polyaxial hemispherical screw - K051063 o Polyaxial U Screws - K013444 o U Screw - K990118 o Hemispherical headed screw - K9901… | 2005 |
| * | K013444 | Isobar Spinal SystemSummary page 1…h are substantially equivalent: · Scient'x previously cleared devices: o Polyaxial hemispherical screw - K051063 o Polyaxial U Screws - K013444 o U Screw - K990118 o Hemispherical headed screw - K990118 o MX Polyaxial screw - K0430… | 2001 |
| * | K990118 | Isobar Spinal SystemSummary page 1…· Scient'x previously cleared devices: o Polyaxial hemispherical screw - K051063 o Polyaxial U Screws - K013444 o U Screw - K990118 o Hemispherical headed screw - K990118 o MX Polyaxial screw - K043001 o MX Monoaxial -… | 1999 |
| * | K043001 | MX Polyaxial Pedicle ScrewSummary page 1…o Polyaxial U Screws - K013444 o U Screw - K990118 o Hemispherical headed screw - K990118 o MX Polyaxial screw - K043001 o MX Monoaxial - K042964 * LTD Polyaxial Screw - K062785 (US Spine) 4. Description of the device:… | 2004 |
| * | K042964 | MX Monoaxial Pedicle ScrewSummary page 1…013444 o U Screw - K990118 o Hemispherical headed screw - K990118 o MX Polyaxial screw - K043001 o MX Monoaxial - K042964 * LTD Polyaxial Screw - K062785 (US Spine) 4. Description of the device: The Scient'x Spinal System consists of… | 2004 |
| * | K062785 | LTD Polyaxial Fixation System Cleared while this submission was under review Summary page 1…o Hemispherical headed screw - K990118 o MX Polyaxial screw - K043001 o MX Monoaxial - K042964 * LTD Polyaxial Screw - K062785 (US Spine) 4. Description of the device: The Scient'x Spinal System consists of monoaxial pedicle screws, rigid rods and c… | 2006 |
What descends from it? (36)
See all 363 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 17 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 45 ancestors have a recall of any class.
- Of its descendants, K133369 (Corelink, LLC, 2014) has gone furthest, with 29 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Scient'x Spinal System is a posterior, noncervical pedicle and non-pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
* Degenerative spondylolisthesis with objective evidence of neurological impairment,
* Fracture,
* Dislocation,
* Kyphosis,
* Spinal tumor, and
* Failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062912: Scient'x Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062912
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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