510(k) · Cleared
ClearedIst Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Spinal Technologies, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Dec 27, 2005 after a 34-day review. The FDA summary names no predicate by number. 69 later devices descend from it.
- Decided
- Dec 27, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
69 later devices descend from it, 4 citing it directly.
- This deviceK053276 Ist Pedicle Screw SystemInnovative Spinal Technologies, Inc. · 2005
- Descendant · cites it directly · 62 of its ownK122571 Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012
- Descendant · cites it directly · 60 of its ownK160902 Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016
- Descendant · 2 generations on · 56 of its ownK173882 SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · Recalled
- Descendant · 2 generations on · 49 of its ownK191648 Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019
- Descendant · 2 generations on · 47 of its ownK211606 Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc. · 2012 · cites it directly62descendants
- K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2016 · cites it directly60descendants
- K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation · 2018 · 2 generations on56descendants
- K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation · 2019 · 2 generations on49descendants
- K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation · 2021 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053276 | Ist Pedicle Screw System | Innovative Spinal Technologies, Inc. | 2005 | — |
| +1 | K122571 | Malibu Spinal System with the Daytona Deformity System | Seaspine, Inc. | 2012 | — |
| +1 | K160902 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2016 | — |
| +2 | K173882 | SeaSpine Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | 2018 | 1 |
| +2 | K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | 2019 | — |
| +2 | K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 9 | 0 |
| 2025 | 14 | 0 |
| 2026 | 15 | 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?
The FDA summary names no predicate by number.
What descends from it? (69)
See all 694 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?
- Of its descendants, K122571 (Seaspine, Inc., 2012) has gone furthest, with 62 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Open or percutaneous approach: When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc…
Read the full statement (174 words)
Open or percutaneous approach:
When used as a pedicle screw fixation system in the lumbar spine of skeletally mature patients, the IST Pedicle Screw System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar spine: 1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2) spinal stenosis, 3) spondylolisthesis, 4) fracture, 5) deformity, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the IST Pedicle Screw System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053276 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053276: Ist Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053276
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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