510(k) · Cleared
Recalled · Class II · 2014Ucr Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 21, 2004 as substantially equivalent to K993503 (International Advanced Medical Enterprises, Inc., 2000) and 2 other predicates after a 29-day review. Its family tree reaches back 7 generations to 1990. 97 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K901587 (1990). 19 ancestors in all. 97 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 5 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 4 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 3 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 2 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 1 generation backK032739 Ucr Spinal SystemSeaspine · 2003
- This deviceK043232 Ucr Spinal SystemSeaspine · 2004
- Descendant · cites it directly · 81 of its ownK051942 Malibu Spinal SystemSeaspine, Inc. · 2005 · Recalled
- Descendant · cites it directly · 81 of its ownK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- Descendant · cites it directly · 80 of its ownK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 67 of its ownK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- Descendant · 2 generations on · 62 of its ownK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
Showing 5 of 97 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 97 · See all- K051942Malibu Spinal SystemSeaspine, Inc. · 2005 · cites it directly81descendants
- K051663Malibu Spinal SystemSeaspine, Inc. · 2005 · cites it directly81descendants
- K061342Malibu Spinal SystemSeaspine, Inc. · 2006 · cites it directly80descendants
- K072605Malibu Spinal SystemSeaspine, Inc. · 2007 · 2 generations on67descendants
- K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012 · 2 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −6 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −5 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −4 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −3 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −2 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −1 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| 0 (this device) | K043232 | Ucr Spinal System | Seaspine | 2004 | — |
| +1 | K051942 | Malibu Spinal System | Seaspine, Inc. | 2005 | 11 |
| +1 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| +1 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| +2 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| +2 | K122571 | Malibu Spinal System with the Daytona Deformity System | Seaspine, Inc. | 2012 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 10 | 0 |
| 2025 | 15 | 0 |
| 2026 | 16 | 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? (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…ts Device Trade Name: UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System (K993503, K021623, and K032739/SI). 1. Intended Use: (The statements of intended use are identical.) The intended use of the… | 2000 |
| * | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsSummary page 1…ice Trade Name: UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System (K993503, K021623, and K032739/SI). 1. Intended Use: (The statements of intended use are identical.) The intended use of the UCR Spina… | 2002 |
| * | K032739 | Ucr Spinal SystemSummary page 1…e: UCR Spinal System The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System (K993503, K021623, and K032739/SI). 1. Intended Use: (The statements of intended use are identical.) The intended use of the UCR Spinal System, pol… | 2003 |
What descends from it? (97)
See all 976 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2014 | Class II | Z-1841-2014 | Under Investigation by firm | Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K051942 (Seaspine, Inc., 2005) has gone furthest, with 81 descendants of its own.
- 5 other devices also cite its predicate K993503.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.…
Read the full statement (312 words)
The intended use of the UCR Spinal System, polyaxial screws, polyaxial reduction screws, cross links, crossbars, rods, caps, set screws, and components, is substantially equivalent to the intended use of the predicate device. The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
* degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
* severe spondylolisthesis (Grades 3 and 4) of the L5-SI 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
* spondylolisthesis,
* trauma (i.e., fracture or dislocation),
* spinal stenosis,
The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to Ti-L5 and are as follows:
* degenerative disc disease (DDD)) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
* spondylolisthesis
* trauma (i.e., fracture or dislocation),
* spinal stenosis,
* deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
* tumor,
*pseudarthiosis, and/or
*failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043232: 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/K043232
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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