510(k) · Cleared
Recalled · Class II · 2014Malibu 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 Oct 25, 2006 as substantially equivalent to K031175 (Synthes (Usa), 2003) and 9 other predicates after a 193-day review. Its family tree reaches back 9 generations to 1990. 80 later devices descend from it. It has been recalled once.
- Decided
- Oct 25, 2006
- Review
- 193 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 9 generations to K901587 (1990). 29 ancestors in all. 80 later devices descend from it, 9 citing it directly.
- Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 5 generations between
- 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 1 generation backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- This deviceK061342 Malibu Spinal SystemSeaspine, Inc. · 2006
- Descendant · cites it directly · 67 of its ownK072605 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
Show all 9 generations
- Root · 9 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 8 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 7 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 6 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 5 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 4 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 3 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 2 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 1 generation backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- This deviceK061342 Malibu Spinal SystemSeaspine, Inc. · 2006
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K072605Malibu Spinal SystemSeaspine, Inc. · 2007 · cites it directly67descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −8 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −7 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −5 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −4 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −3 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −2 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −1 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| 0 (this device) | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 7 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 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? (10)
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 |
|---|---|---|---|
| * | K031175 | Click'x Monoaxial Screws and HooksSummary page 1…Device Trade Name: MalibuTm The devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K0… | 2003 |
| * | K002607 | Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and Sacral…Summary page 1…devices used for comparison in this summary are Synthes Spine Company's Synthes Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal Sys… | 2000 |
| * | K992168 | Moss Miami 6.35MM Polyaxial ScrewSummary page 1…d for comparison in this summary are Synthes Spine Company's Synthes Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 166… | 1999 |
| * | K993503 | Haider-Ucr Spinal SystemSummary page 1…Company's Synthes Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The… | 2000 |
| * | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsSummary page 1…Synthes Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The statement… | 2002 |
| * | K031381 | Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and InstrumentsSummary page 1…s Click'X Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The statements of inte… | 2003 |
| * | K032739 | Ucr Spinal SystemSummary page 1…Monomxial Screw System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The statements of intended use… | 2003 |
| * | K043232 | Ucr Spinal SystemSummary page 1…w System (K031 175), DePuy Acromed's Moss Miami Spinal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The statements of intended use are identical.)… | 2004 |
| * | K051663 | Malibu Spinal System | 2005 |
| * | K051942 | Malibu Spinal SystemSummary page 1…inal System (K002607 and K992168), and SeaSpine Inc.'s UCR Spinal System (K993503, K021623, K031381, K032739/Sl and K043232) and Malibu Spinal System (KO5 1663 and KO051942). 1. Intended Use: (The statements of intended use are identical.) The intended use of the Malibu system is as a t… | 2005 |
What descends from it? (80)
See all 809 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072605 | Malibu Spinal System | 2007 | 67 |
| 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 |
| K120047 | Coral Spinal System | 2012 | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 22, 2014 | Class II | Z-0938-2014 | Manufacturing material removal | Integra LifeSciences has identified through an investigation of complaints that there may be the potential for the shaft of the Malibu Polyaxial Drivers to break during use. None of the complaints reported a patient injury. However, some… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 29 ancestors have a recall of any class.
- Of its descendants, K072605 (Seaspine, Inc., 2007) has gone furthest, with 67 descendants of its own.
- 19 other devices also cite its predicate K031175.
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 Malibu 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 Malibu 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…
Read the full statement (300 words)
The intended use of the Malibu 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 Malibu 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-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 (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.
The intended use and indications of the Malibu 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,
* pseudarthosis, and/or
* failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061342: Malibu 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/K061342
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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