510(k) · Cleared
Recalled · Class II · 2024Mariner RDX 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 Sep 7, 2022 as substantially equivalent to K160902 (SeaSpine Orthopedics Corporation, 2016) and 2 other predicates after a 51-day review. Its family tree reaches back 15 generations to 1990. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 7, 2022
- Review
- 51 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 15 generations to K901587 (1990). 127 ancestors in all, the oldest K842956 (1984). 8 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 11 generations between
- 3 generations backK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- 2 generations backK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- 1 generation backK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK222110 Mariner RDX SystemSeaSpine Orthopedics Corporation · 2022
- Descendant · cites it directly · 4 of its ownK251804 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · 2 generations on · 2 of its ownK253990 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · 2 generations on · 2 of its ownK253721 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025
- Descendant · cites it directly · 2 of its ownK250908 Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 2025 · Recalled
- Descendant · 2 generations on · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 15 generations
- Root · 15 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 14 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 13 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 12 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 11 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 10 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 9 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 8 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 7 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 6 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 5 generations backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- 4 generations backK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- 3 generations backK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- 2 generations backK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- 1 generation backK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- This deviceK222110 Mariner RDX SystemSeaSpine Orthopedics Corporation · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · cites it directly4descendants
- K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on2descendants
- K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2025 · 2 generations on2descendants
- K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 2025 · cites it directly2descendants
- K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −14 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −13 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −12 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −11 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −10 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −9 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −8 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −7 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −6 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| −5 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| −4 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| −3 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| −2 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
| −1 | K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 | — |
| 0 (this device) | K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022 | — |
| +1 | K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +2 | K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +2 | K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2025 | — |
| +1 | K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | 2025 | 1 |
| +2 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
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 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K160902 | Mariner Pedicle Screw SystemSummary page 4…Trade Name Manufacturer Primary Predicate Device Mariner Pedicle Screw SeaSpine Orthopedics K160902 NKB, KWP, MNH, MNI System Corporation Additional Pred… | 2016 |
| * | K212692 | Mariner Pedicle Screw SystemSummary page 4…System Corporation Additional Predicate Device(s) Mariner Pedicle Screw SeaSpine Orthopedics K212692 NKB, KWP, KWQ System Corporation… | 2021 |
| * | K122571 | Malibu Spinal System with the Daytona Deformity SystemSummary page 4…orporation Malibu Spinal System with the SeaSpine Orthopedics K122571 NKB, KWP, MNI, MNH Daytona Deformity Corporation… | 2012 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251804 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2025 | 4 |
| K250908 | Virata Spinal Fixation System | 2025 | 2 |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System… | 2024 | 1 |
| K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2024 | Class II | Z-1620-2024 | Nonconforming Material/Component | Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
| Feb 15, 2024 | Class II | Z-1605-2024 | Nonconforming Material/Component | Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 19 of the 127 ancestors have a recall of any class.
- Of its descendants, K251804 (S.M.A.I.O, 2025) has gone furthest, with 4 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. 2022, 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 (114 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222110: Mariner RDX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222110
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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