510(k) · Cleared
ClearedUcr Spinal System
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 Nov 20, 2003 as substantially equivalent to K993503 (International Advanced Medical Enterprises, Inc., 2000) and 2 other predicates after a 77-day review. Its family tree reaches back 6 generations to 1990. 174 later devices descend from it.
- Decided
- Nov 20, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K901587 (1990). 18 ancestors in all. 174 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 4 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 3 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 2 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 1 generation backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- This deviceK032739 Ucr Spinal SystemSeaspine · 2003
- Descendant · cites it directly · 97 of its ownK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- Descendant · cites it directly · 91 of its ownK081331 Fixxsure Cross LinkSpineworks, LLC · 2008
- Descendant · 2 generations on · 89 of its ownK110692 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 3 generations on · 88 of its ownK111502 Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011
- Descendant · 4 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
Showing 5 of 174 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 174 · See all- K043232Ucr Spinal SystemSeaspine · 2004 · cites it directly97descendants
- K081331Fixxsure Cross LinkSpineworks, LLC · 2008 · cites it directly91descendants
- K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 2 generations on89descendants
- K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc. · 2011 · 3 generations on88descendants
- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 4 generations on82descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −5 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −4 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −1 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| 0 (this device) | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| +1 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| +1 | K081331 | Fixxsure Cross Link | Spineworks, LLC | 2008 | — |
| +2 | K110692 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +3 | K111502 | Streamline TL Spinal System | Pioneer Surgical Technology, Inc. | 2011 | — |
| +4 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K993503 | Haider-Ucr Spinal SystemSummary page 1…de Name: UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System cross links (K993503, K021623, and K031381). 1. Intended Use: (The statements of intended use are identical.) The intended use and in… | 2000 |
| * | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsSummary page 1…UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System cross links (K993503, K021623, and K031381). 1. Intended Use: (The statements of intended use are identical.) The intended use and indications… | 2002 |
| * | K031381 | Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and InstrumentsSummary page 1…UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System cross links (K993503, K021623, and K031381). 1. Intended Use: (The statements of intended use are identical.) The intended use and indications when used as… | 2003 |
What descends from it? (174)
See all 1746 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 13 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K043232 (Seaspine, 2004) has gone furthest, with 97 descendants of its own.
- 5 other devices also cite its predicate K993503.
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 variable and fixed cross links remains the same as that of the existing variable and fixed cross links. 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…
Read the full statement (177 words)
The intended use of the UCR Spinal System variable and fixed cross links remains the same as that of the existing variable and fixed cross links.
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 neurological impairment,
fracture,
dislocation,
scoliosis,
kyphosis,
spinal tumor, and
failed previous fusion (pseudoarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032739 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032739: Ucr 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/K032739
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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