510(k) · Cleared
ClearedModification to Synthes Universal Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 30, 1999 after a 22-day review. The FDA summary names its predicate without a number. 2 of the 917 devices in its family, counting itself, have a Class I recall. 916 later devices descend from it.
- Decided
- Mar 30, 1999
- Review
- 22 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
916 later devices descend from it, 3 citing it directly. 2 of the 917 devices in this family, counting this one, have a Class I recall.
- This deviceK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- Descendant · cites it directly · 912 of its ownK992739 Click'xSynthes Spine · 2000 · Recalled
- Descendant · 2 generations on · 774 of its ownK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- Descendant · 2 generations on · 659 of its ownK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- Descendant · 3 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · 2 generations on · 551 of its ownK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
Showing 5 of 916 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 916 · See all- K992739Click'xSynthes Spine · 2000 · cites it directly912descendants
- K052123Synthes Pangea SystemSynthes (Usa) · 2005 · 2 generations on774descendants
- K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · 2 generations on659descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 3 generations on581descendants
- K040442Protex Stabilization SystemGlobus Medical, Inc. · 2004 · 2 generations on551descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| +1 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| +2 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| +2 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| +3 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +2 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 12 | 0 |
| 2010 | 16 | 1 |
| 2011 | 19 | 0 |
| 2012 | 35 | 0 |
| 2013 | 42 | 0 |
| 2014 | 46 | 0 |
| 2015 | 57 | 0 |
| 2016 | 49 | 0 |
| 2017 | 57 | 0 |
| 2018 | 58 | 0 |
| 2019 | 45 | 0 |
| 2020 | 57 | 0 |
| 2021 | 44 | 1 |
| 2022 | 61 | 0 |
| 2023 | 87 | 0 |
| 2024 | 77 | 0 |
| 2025 | 64 | 0 |
| 2026 | 67 | 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.
2 devices in this family have a Class I recall. 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? (1)
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 |
|---|---|---|---|
| * | — | Synthes spinal systems Named without a submission number |
What descends from it? (916)
See all 9163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K992739 (Synthes Spine, 2000) has gone furthest, with 912 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.
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?
When used as a posterior pedicle screw fixation system, the Synthes USS 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal…
Read the full statement (237 words)
When used as a posterior pedicle screw fixation system, the Synthes USS 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, the Synthes USS is intended for 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 with removal of the implants after the attainment of a solid fusion. The levels of pedicle screw fixation for these patients are L3-S2.
When used as a posterior non-pedicle screw fixation system, the Synthes USS is intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schuermann's disease), degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). and fractures of the posterior thoracolumbar spine.
In addition, when used with 3.5/6.0 mm parallel connectors, the Synthes USS can be linked to the CerviFix System.
Anterior components of the USS are intended for anterolateral screw and/or staple fixation for the correction of anterolateral lordotic deformities for the spine, lumbar scoliosis, pseudoarthrosis, and fracture or dislocation of the thoracolumbar spine (levels T8-LS).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990745: Modification to Synthes Universal Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990745
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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