510(k) · Cleared
ClearedST360 Spinal Fixation System, Model 07.0029-7500.5600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 5, 2007 as substantially equivalent to K022374 (Sulzer Spine-Tech, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 4 generations to 1998. 27 later devices descend from it.
- Decided
- Sep 5, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K980288 (1998). 27 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- 3 generations backK992276 Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- 2 generations backK022374 Cadence Spinal Fixation SystemSulzer Spine-Tech · 2002 · Recalled
- 1 generation backK041925 ST360 Spinal Fixation SystemZimmer Spine, Inc. · 2004 · Recalled
- This deviceK072183 ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc. · 2007
- Descendant · cites it directly · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- Descendant · 2 generations on · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
- Descendant · 3 generations on · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013
- Descendant · 4 generations on · 14 of its ownK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
- Descendant · 3 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · cites it directly24descendants
- K080767Conquest Spinal SystemLife Spine · 2008 · 2 generations on21descendants
- K123373Nautilus Spinal SystemLife Spine · 2013 · 3 generations on17descendants
- K132760Nautilus Spinal SystemLife Spine, Inc. · 2013 · 4 generations on14descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| −3 | K992276 | Modification to Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| −2 | K022374 | Cadence Spinal Fixation System | Sulzer Spine-Tech | 2002 | 1 |
| −1 | K041925 | ST360 Spinal Fixation System | Zimmer Spine, Inc. | 2004 | 1 |
| 0 (this device) | K072183 | ST360 Spinal Fixation System, Model 07.0029-7500.5600 | Zimmer Spine, Inc. | 2007 | — |
| +1 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| +2 | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
| +3 | K123373 | Nautilus Spinal System | Life Spine | 2013 | — |
| +4 | K132760 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| +3 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K022374 | Cadence Spinal Fixation SystemSummary page 1…k, and screw spinal instrumentation Classification: Class III Product Codes: NKB, MNi, MNH, KWP Predicate Device: ST360°® Spinal Fixation System (K022374, K041925) Device Description: The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity… | 2002 |
| * | K041925 | ST360 Spinal Fixation SystemSummary page 1…rew spinal instrumentation Classification: Class III Product Codes: NKB, MNi, MNH, KWP Predicate Device: ST360°® Spinal Fixation System (K022374, K041925) Device Description: The ST360°® Spinal Fixation System is a temporary implant system used to correct spinal deformity and facil… | 2004 |
What descends from it? (27)
See all 272 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 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K073430 (Amedica Corp., 2008) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K022374.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 ST360° Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and…
Read the full statement (201 words)
The ST360° Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a hook and sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360 ° Spinal Fixation System are intended for the sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are Tl to the sacrim.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072183: ST360 Spinal Fixation System, Model 07.0029-7500.5600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072183
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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