510(k) · Cleared
ClearedUcr Spinal System, 5.5MM, 8.0MM Screws & Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iame, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Sep 10, 2002 as substantially equivalent to K993503 (International Advanced Medical Enterprises, Inc., 2000) after a 117-day review. Its family tree reaches back 5 generations to 1990. 175 later devices descend from it.
- Decided
- Sep 10, 2002
- Review
- 117 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K901587 (1990). 16 ancestors in all. 175 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 4 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 3 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 2 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 1 generation backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- This deviceK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- Descendant · cites it directly · 174 of its ownK032739 Ucr Spinal SystemSeaspine · 2003
- Descendant · cites it directly · 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 · cites it directly97descendants
- 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 |
|---|---|---|---|---|---|
| −5 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −4 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −3 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −2 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −1 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| 0 (this device) | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| +1 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| +1 | 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 | — |
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 |
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 MNH? 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 |
|---|---|---|---|
| * | K993503 | Haider-Ucr Spinal SystemSummary page 3…YES K -Number: KO21623 K993503 YES… | 2000 |
What descends from it? (175)
See all 1757 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 12 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K032739 (Seaspine, 2003) has gone furthest, with 174 descendants of its own.
- 5 other devices also cite its predicate K993503.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HAIDER-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 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. The HAIDER-UCR Spinal System is a pedicle screw system intended to provide immobilization and…
Read the full statement (123 words)
The HAIDER-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 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.
The HAIDER-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 hsion pseudarthrosis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021623 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021623
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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