510(k) · Cleared
ClearedSeaSpine NewPort Spinal 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 Feb 20, 2018 as substantially equivalent to K161535 (SeaSpine Orthopedics Corporation, 2016) and 6 other predicates after a 29-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Feb 20, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K901587 (1990). 57 ancestors in all. No later device cites it as a predicate yet.
- 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 backK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
- This deviceK180176 SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation · 2018
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 backK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
- This deviceK180176 SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation · 2018
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 | K122571 | Malibu Spinal System with the Daytona Deformity System | Seaspine, Inc. | 2012 | — |
| 0 (this device) | K180176 | SeaSpine NewPort Spinal System | SeaSpine Orthopedics Corporation | 2018 | — |
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 | 6 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K161535 | SeaSpine® NewPort™ Spinal SystemSummary page 4…PREDICATE Device SeaSpine SeaSpine NewPort Spinal K161535 NKB Orthopedics System… | 2016 |
| * | K083089 | Newport Spinal SystemSummary page 4…Predicate Devices SeaSpine SeaSpine NewPort Spinal K083089 NKB Orthopedics System… | 2009 |
| * | K122571 | Malibu Spinal System with the Daytona Deformity SystemSummary page 4…Orthopedics System Corporation K122571, K072605, SeaSpine NKB K061342, K051942,… | 2012 |
| * | K072605 | Malibu Spinal SystemSummary page 4…Orthopedics System Corporation K122571, K072605, SeaSpine NKB K061342, K051942,… | 2007 |
| * | K061342 | Malibu Spinal SystemSummary page 4…Corporation K122571, K072605, SeaSpine NKB K061342, K051942, SeaSpine Malibu System Orthopedics K051663… | 2006 |
| * | K051942 | Malibu Spinal SystemSummary page 4…Corporation K122571, K072605, SeaSpine NKB K061342, K051942, SeaSpine Malibu System Orthopedics K051663… | 2005 |
| * | K051663 | Malibu Spinal SystemSummary page 4…SeaSpine NKB K061342, K051942, SeaSpine Malibu System Orthopedics K051663 Corporation… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 57 ancestors have a recall of any class.
- 1 other device also cites its predicate K161535.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SeaSpine NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications: - Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc…
Read the full statement (150 words)
The SeaSpine NewPort Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:
- 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,
- 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.
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/K180176 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180176: SeaSpine NewPort 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/K180176
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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