510(k) · Cleared
ClearedMalibu Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seaspine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 20, 2007 as substantially equivalent to K061342 (Seaspine, Inc., 2006) and 4 other predicates after a 94-day review. Its family tree reaches back 10 generations to 1990. 67 later devices descend from it.
- Decided
- Dec 20, 2007
- Review
- 94 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K901587 (1990). 52 ancestors in all. 67 later devices descend from it, 7 citing it directly.
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations between
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 1 generation backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- This deviceK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- Descendant · cites it directly · 62 of its ownK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
- Descendant · cites it directly · 60 of its ownK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 56 of its ownK173882 SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
- Descendant · 2 generations on · 49 of its ownK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 47 of its ownK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
Show all 10 generations
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 9 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 8 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 7 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 6 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 5 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 4 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 1 generation backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- This deviceK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012 · cites it directly62descendants
- K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016 · cites it directly60descendants
- K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · cites it directly56descendants
- K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on49descendants
- K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −9 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −8 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −5 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −4 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −3 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −2 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −1 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| 0 (this device) | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| +1 | K122571 | Malibu Spinal System with the Daytona Deformity System | Seaspine, Inc. | 2012 | — |
| +1 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K173882 | SeaSpine Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2018 | 1 |
| +2 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 0 |
| 2026 | 15 | 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? (5)
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 |
|---|---|---|---|
| * | K061342 | Malibu Spinal SystemSummary page 1…al Fixation Orthosis KWP (Class II) - 888.3050 Predicate Devices: SeaSpine, Malibu Spinal System (K061342, K051942, K051663) Medtronic Sofamor Danek, MSD… | 2006 |
| * | K051942 | Malibu Spinal SystemSummary page 1…on Orthosis KWP (Class II) - 888.3050 Predicate Devices: SeaSpine, Malibu Spinal System (K061342, K051942, K051663) Medtronic Sofamor Danek, MSD Wire Sys… | 2005 |
| * | K051663 | Malibu Spinal SystemSummary page 1…KWP (Class II) - 888.3050 Predicate Devices: SeaSpine, Malibu Spinal System (K061342, K051942, K051663) Medtronic Sofamor Danek, MSD Wire System (K020… | 2005 |
| * | K020426 | MSD Wire System | 2002 |
| * | K060979 | Xia Titanium and 4.5 Spinal SystemsSummary page 1…Medtronic Sofamor Danek, MSD Wire System (K020.426) Stryker Spine, Xia Spinal System (K060979) Device Description: The system contains titanium alloy and cobalt alloy implants. This submission is intended to a… | 2006 |
What descends from it? (67)
See all 677 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122571 | Malibu Spinal System with the Daytona Deformity System | 2012 | 62 |
| K160902 | Mariner Pedicle Screw System | 2016 | 60 |
| K173882 | SeaSpine Mariner Pedicle Screw System | 2018 | 56 |
| K161535 | SeaSpine® NewPort™ Spinal System | 2016 | 14 |
| K180686 | SeaSpine Daytona Small Stature Spinal System | 2018 | 12 |
| K163604 | SeaSpine® Daytona® Small Stature Spinal System | 2017 | 12 |
| K180176 | SeaSpine NewPort Spinal System | 2018 | 0 |
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 17 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 52 ancestors have a recall of any class.
- Of its descendants, K122571 (Seaspine, Inc., 2012) has gone furthest, with 62 descendants of its own.
- 8 other devices also cite its predicate K061342.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
1. The intended use of the Malibu 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…
Read the full statement (267 words)
1. The intended use of the Malibu 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,
* deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
* spinal tumor,
* pseudoarthrosis, and/or
* failed previous fusion.
2. The intended use and indications of the Malibu system, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System or Sublaminar Wire System, are limited to T1I-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,
* spondylolisthiesis,
* trauma (ie., fracture or dislocation),
* spinal stenosis,
* deformities or curvatures (iLe., scoliosis, kyphosis, and/or lordosis),
* tumor,
* pseudarthosis, and/or
* failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072605: Malibu Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072605
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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