510(k) · Cleared
ClearedSolas Anatomix Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotechni America Spine Group, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Feb 23, 2009 as substantially equivalent to K051959 (Nv Cormed, 2005) and 2 other predicates after a 118-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Feb 23, 2009
- Review
- 118 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K001319 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK001319 Xia Spine System HooksHowmedica Osteonics Corp. · 2000
- This deviceK083178 Solas Anatomix Spinal SystemBiotechni America Spine Group, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001319 | Xia Spine System Hooks | Howmedica Osteonics Corp. | 2000 | — |
| 0 (this device) | K083178 | Solas Anatomix Spinal System | Biotechni America Spine Group, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K051959 | NV Cormed Solas Spinal SystemSummary page 1…da.qov/scripts/cdrh/cfdocs/cfPCD/cassificationcfm?lD=3899) Legally Marketed Predicate Devices for the Application: NV Cormed, SOLAS TM Spinal System -MNH, KWQ, MNI - (K051959) Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryker® Spine, XIA TM Spinal Sy… | 2005 |
| * | K002059 | Amt Spinal SystemSummary page 1…eted Predicate Devices for the Application: NV Cormed, SOLAS TM Spinal System -MNH, KWQ, MNI - (K051959) Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryker® Spine, XIA TM Spinal System -- MNH, MNI, KWQ -- (K001319) Device Description: The SOLASAnatom… | 2000 |
| * | K001319 | Xia Spine System HooksSummary page 1…MNI - (K051959) Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryker® Spine, XIA TM Spinal System -- MNH, MNI, KWQ -- (K001319) Device Description: The SOLASAnatomix Spinal System is a new modular spinal fixation system which can be used for anterior,… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOLAS AnatomixTM is intended to…
Read the full statement (188 words)
The BASG, Inc., SOLAS AnatomixTM, Spinal System is a modular pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, the SOLAS AnatomixTM is 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The SOLAS AnatomixTM is intended for anterior/anterolateral and posterior, non-cervical and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture and/or dislocation) spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083178: Solas Anatomix 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/K083178
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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