510(k) · Cleared
Recalled · Class II · 2025Virata Spinal Fixation 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 Jun 18, 2025 as substantially equivalent to K222110 (SeaSpine Orthopedics Corporation, 2022) and 2 other predicates after an 84-day review. Its family tree reaches back 16 generations to 1990. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 18, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 16 generations to K901587 (1990). 167 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 12 generations between
- 3 generations backK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- 2 generations backK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- 1 generation backK222110 Mariner RDX SystemSeaSpine Orthopedics Corporation · 2022 · Recalled
- This deviceK250908 Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 2025
- Descendant · cites it directly · 1 of its ownK260786 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
- Descendant · cites it directly · 0 of its ownK262828 KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O · 2026
Show all 16 generations
- Root · 16 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 15 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 14 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 13 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 12 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 11 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 10 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 9 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 8 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 7 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 6 generations backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- 5 generations backK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- 4 generations backK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- 3 generations backK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
- 2 generations backK212692 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2021
- 1 generation backK222110 Mariner RDX SystemSeaSpine Orthopedics Corporation · 2022 · Recalled
- This deviceK250908 Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −15 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −14 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −13 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −12 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −11 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −10 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −9 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −8 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −7 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| −6 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| −5 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| −4 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| −3 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
| −2 | K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2021 | — |
| −1 | K222110 | Mariner RDX System | SeaSpine Orthopedics Corporation | 2022 | 2 |
| 0 (this device) | K250908 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | 2025 | — |
| +1 | K260786 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | 2026 | — |
| +1 | K262828 | 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 | 2 | 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 | 12 | 0 |
| 1996 | 5 | 0 |
| 1997 | 7 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 7 | 0 |
| 2003 | 9 | 0 |
| 2004 | 13 | 0 |
| 2005 | 13 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 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 |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K222110 | Mariner RDX SystemSummary page 5…Manufacturer Code(s) Primary Predicate NKB, KWP, SeaSpine Mariner Pedicle SeaSpine Orthopedics K222110 KWQ Screw System Corporation Additional Predicate Device(s)… | 2022 |
| * | K132014 | GSB Global Spinal Balance SystemSummary page 5…Screw System Corporation Additional Predicate Device(s) NKB, KWP, NuVasive GSB Global Spinal K132014 KWQ, MNH, NuVasive, Inc. Balance System… | 2013 |
| * | K172517 | SeaSpine Navigation SystemSummary page 5…Inc. Balance System MNI SeaSpine Navigation SeaSpine Orthopedics K172517 OLO Instruments Corporation D. Device Description The Vir… | 2018 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Sep 19, 2025 | Class II | Z-0478-2026 | Process change control | Polyaxial screws do not meet performance standards. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 24 of the 167 ancestors have a recall of any class.
- Of its descendants, K260786 (S.M.A.I.O, 2026) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K222110.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Virata Spinal Fixation 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 (ODD) as defined by back pain of discogenic origin…
Read the full statement (286 words)
The intended use of the Virata Spinal Fixation 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 (ODD) 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.
When used for posterior non-cervical screw fixation in pediatric patients, the Virata Spinal Fixation System is also indicated as adjunct to fusion to treat:
- Adolescent Idiopathic Scoliosis (AIS)
- Neuromuscular scoliosis
- Congenital scoliosis
The Virata Spinal Fixation System can be used with components of the Mariner and Malibu Systems such as rods and connectors. The Virata Spinal Fixation System is intended to be used with autograft or allograft.
Virata Spinal Fixation Navigated Instruments
The Virata Spinal Fixation Navigated Instruments are intended to be used in the preparation and placement of Virata screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250908 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250908: Virata Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250908
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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