510(k) · Cleared
ClearedSynthes Matrix Mis Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 9, 2010 after a 102-day review. The FDA summary names no predicate by number. 94 later devices descend from it.
- Decided
- Mar 9, 2010
- Review
- 102 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 3 citing it directly.
- This deviceK093668 Synthes Matrix Mis RodsSynthes (Usa) · 2010
- Descendant · cites it directly · 93 of its ownK113044 Synthes MirsSynthes Spine · 2011 · Recalled
- Descendant · 2 generations on · 74 of its ownK120571 Synthes Uss ConnectorSynthes Spine · 2012
- Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 4 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · 5 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K113044Synthes MirsSynthes Spine · 2011 · cites it directly93descendants
- K120571Synthes Uss ConnectorSynthes Spine · 2012 · 2 generations on74descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 4 generations on30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093668 | Synthes Matrix Mis Rods | Synthes (Usa) | 2010 | — |
| +1 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
| +2 | K120571 | Synthes Uss Connector | Synthes Spine | 2012 | — |
| +3 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +4 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +5 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 12 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 9 | 0 |
| 2024 | 12 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 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?
The FDA summary names no predicate by number.
What descends from it? (94)
See all 943 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?
- Of its descendants, K113044 (Synthes Spine, 2011) has gone furthest, with 93 descendants of its own.
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 Synthes UISS (including Matrix, UISS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USSVNAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (Ti -S2/lium), a posterior hook fixation system (T1 -L5), or as…
Read the full statement (327 words)
The Synthes UISS (including Matrix, UISS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USSVNAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (Ti -S2/lium), a posterior hook fixation system (T1 -L5), or as an anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DIDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0-mm parallel connectors, the Synthes UISS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix) can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature UISS can be linked to the Synthes USS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix).
In addition, Synthes UISS (including UISS Side-Opening, UISS Dual-Opening, UISS VAS variable axis components, UISS Fracture, Click'X, Ciick'X Monoaxial, Pangea, Pangea Monoaxial, UISS Polyaxial, UISS Iliosacral, and ClampFix) can be interchanged with all UISS 6.0 mm rods and transconnectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093668: Synthes Matrix Mis Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093668
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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