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 Sep 8, 2016 as substantially equivalent to K083089 (Seaspine, Inc., 2009) and 5 other predicates after a 97-day review. Its family tree reaches back 11 generations to 1990. 14 later devices descend from it.
- Decided
- Sep 8, 2016
- Review
- 97 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K901587 (1990). 55 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 7 generations between
- 3 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 2 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 1 generation backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- This deviceK161535 SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · cites it directly · 12 of its ownK163604 SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017
- Descendant · 2 generations on · 8 of its ownK183639 Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 3 generations on · 7 of its ownK193396 PERLA® TL posterior osteosynthesis systemSpineart · 2020 · Recalled
- Descendant · 4 generations on · 4 of its ownK203222 PERLA TL Posterior Osteosynthesis SystemSpineart · 2020
- Descendant · 4 generations on · 3 of its ownK203506 PERLA® TL posterior osteosynthesis systemSpineart · 2021 · Recalled
Show all 11 generations
- Root · 11 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 10 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 9 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 8 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 7 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 6 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 5 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 4 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 3 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 2 generations backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- 1 generation backK072605 Malibu Spinal SystemSeaspine, Inc. · 2007
- This deviceK161535 SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation · 2017 · cites it directly12descendants
- K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on8descendants
- K193396PERLA® TL posterior osteosynthesis systemSpineart · 2020 · 3 generations on7descendants
- K203222PERLA TL Posterior Osteosynthesis SystemSpineart · 2020 · 4 generations on4descendants
- K203506PERLA® TL posterior osteosynthesis systemSpineart · 2021 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −10 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −9 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −8 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −6 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −5 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −4 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −3 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −2 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| −1 | K072605 | Malibu Spinal System | Seaspine, Inc. | 2007 | — |
| 0 (this device) | K161535 | SeaSpine® NewPort™ Spinal System | SeaSpine Orthopedics Corporation | 2016 | — |
| +1 | K163604 | SeaSpine® Daytona® Small Stature Spinal System | SeaSpine Orthopedics Corporation | 2017 | — |
| +2 | K183639 | Mariner Outrigger Revision System | SeaSpine Orthopedics Corporation | 2019 | — |
| +3 | K193396 | PERLA® TL posterior osteosynthesis system | Spineart | 2020 | 2 |
| +4 | K203222 | PERLA TL Posterior Osteosynthesis System | Spineart | 2020 | — |
| +4 | K203506 | PERLA® TL posterior osteosynthesis system | Spineart | 2021 | 2 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K083089 | Newport Spinal SystemSummary page 4…Product Code: MNI, Class II 3. Legally Marketed Predicate Device(s) 510(k) Number Product Code Trade Name Manufacturer K083089 NewPort™ NKB, MNH, MNI SeaSpine, Inc. (P… | 2009 |
| * | K053276 | Ist Pedicle Screw SystemSummary page 4…NewPort™ NKB, MNH, MNI SeaSpine, Inc. (Primary Predicate) System K053276 IST Pedicle SeaSpine, Inc. NKB, MNH, MNI Screw System… | 2005 |
| * | K051663 | Malibu Spinal SystemSummary page 4…System K053276 IST Pedicle SeaSpine, Inc. NKB, MNH, MNI Screw System (Additional Predicate) K051663 NKB, MNH, MNI Malibu™ Spinal SeaSpine, Inc. K051942 System K0613… | 2005 |
| * | K051942 | Malibu Spinal SystemSummary page 4…ne, Inc. NKB, MNH, MNI Screw System (Additional Predicate) K051663 NKB, MNH, MNI Malibu™ Spinal SeaSpine, Inc. K051942 System K061342 K072605 (Additional Predicate)… | 2005 |
| * | K061342 | Malibu Spinal SystemSummary page 4…Screw System (Additional Predicate) K051663 NKB, MNH, MNI Malibu™ Spinal SeaSpine, Inc. K051942 System K061342 K072605 (Additional Predicate) K… | 2006 |
| * | K072605 | Malibu Spinal SystemSummary page 4…System (Additional Predicate) K051663 NKB, MNH, MNI Malibu™ Spinal SeaSpine, Inc. K051942 System K061342 K072605 (Additional Predicate) K161535… | 2007 |
What descends from it? (14)
See all 142 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 26 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 55 ancestors have a recall of any class.
- Of its descendants, K163604 (SeaSpine Orthopedics Corporation, 2017) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K083089.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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…
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 as stated in the FDA summary.
https://510kreport.com/device/K161535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161535: SeaSpine® NewPort™ 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/K161535
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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