510(k) · Cleared
ClearedUcr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 30, 2003 after a 90-day review. The FDA summary names its predicate without a number. 175 later devices descend from it.
- Decided
- Jul 30, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
175 later devices descend from it, 4 citing it directly.
- This deviceK031381 Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and InstrumentsSeaspine · 2003
- Descendant · cites it directly · 174 of its ownK032739 Ucr Spinal SystemSeaspine · 2003
- Descendant · 2 generations on · 97 of its ownK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- Descendant · 2 generations on · 91 of its ownK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- Descendant · 3 generations on · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 4 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
Showing 5 of 175 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 175 · See all- K032739Ucr Spinal SystemSeaspine · 2003 · cites it directly174descendants
- K043232Ucr Spinal SystemSeaspine · 2004 · 2 generations on97descendants
- K081331Fixxsure Cross LinkSpineworks, LLC · 2008 · 2 generations on91descendants
- K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 3 generations on89descendants
- K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 4 generations on88descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031381 | Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments | Seaspine | 2003 | — |
| +1 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| +2 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| +2 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| +3 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +4 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 19 | 0 |
| 2024 | 22 | 0 |
| 2025 | 28 | 0 |
| 2026 | 25 | 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? (2)
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 |
|---|---|---|---|
| * | — | Synergy Posterior Spinal System Named without a submission number | |
| * | — | CD Horizon Named without a submission number |
What descends from it? (175)
See all 1754 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, K032739 (Seaspine, 2003) has gone furthest, with 174 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?
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use and indications when used as a Spondylolisthesis Spinal Fixation…
Read the full statement (261 words)
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions 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.
The intended use and indications when used as a Pedicle Screw Spinal System are:
The UCR Spinal System is a pedicle screw 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 the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Hook Spinal System indications are limited to T1-L5 and are: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic), spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, and/or lordosis), fracture, pseudarthosis, tumor resection, and/or failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031381 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031381: Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031381
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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