510(k) · Cleared
ClearedMariner MIS Pedicle Screw System; SeaSpine Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SeaSpine Orthopedics Corporation · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 19, 2019 as substantially equivalent to K160902 (SeaSpine Orthopedics Corporation, 2016) and 1 other predicate after a 29-day review. Its family tree reaches back 12 generations to 1990. 49 later devices descend from it.
- Decided
- Jul 19, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K901587 (1990). 122 ancestors in all, the oldest K842956 (1984). 49 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 8 generations between
- 3 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 2 generations backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- 1 generation backK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- This deviceK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · cites it directly · 47 of its ownK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- Descendant · 2 generations on · 46 of its ownK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- Descendant · 3 generations on · 32 of its ownK220195 iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022
- Descendant · 4 generations on · 20 of its ownK222774 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Show all 12 generations
- Root · 12 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 11 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 10 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 9 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 8 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 7 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 6 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 5 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 4 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 3 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 2 generations backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- 1 generation backK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- This deviceK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · cites it directly47descendants
- K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on46descendants
- K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc. · 2022 · 3 generations on32descendants
- K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2022 · 4 generations on20descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −11 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −10 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −9 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −8 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −7 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −6 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −5 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −4 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −3 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| −2 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| −1 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| 0 (this device) | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| +1 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
| +2 | K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 | — |
| +3 | K220195 | iFuse Bedrock Granite™ Implant System | SI-BONE, Inc. | 2022 | — |
| +4 | K222774 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2022 | — |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 7 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 10 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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? (2)
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 |
|---|---|---|---|
| * | K160902 | Mariner Pedicle Screw SystemSummary page 6…Trade Name Manufacturer PRIMARY PREDICATE Device Mariner Pedicle Screw SeaSpine Orthopedics K160902 NKB System Corporation 2. 510(k) Number Pro… | 2016 |
| * | K172517 | SeaSpine Navigation SystemSummary page 6…Trade Name Manufacturer PRIMARY PREDICATE Device SeaSpine Navigation SeaSpine Orthopedics K172517 OLO System Corporation Device Description T… | 2018 |
What descends from it? (49)
See all 492 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 29 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 122 ancestors have a recall of any class.
- Of its descendants, K211606 (SeaSpine Orthopedics Corporation, 2021) has gone furthest, with 47 descendants of its own.
- 3 other devices also cite its predicate K160902.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach 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…
Read the full statement (213 words)
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach 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
spondylolisthesis
trauma (i.e., fracture or dislocation)
spinal stenosis
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
spinal tumor
pseudarthrosis, and/or
failed previous fusion.
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191648: Mariner MIS Pedicle Screw System; SeaSpine Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191648
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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