510(k) · Cleared
Recalled · 2006ST360 Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 24, 2004 as substantially equivalent to K022374 (Sulzer Spine-Tech, 2002) after a 67-day review. Its family tree reaches back 3 generations to 1998. 83 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2004
- Review
- 67 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980288 (1998). 83 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- 2 generations backK992276 Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- 1 generation backK022374 Cadence Spinal Fixation SystemSulzer Spine-Tech · 2002 · Recalled
- This deviceK041925 ST360 Spinal Fixation SystemZimmer Spine, Inc. · 2004
- Descendant · cites it directly · 42 of its ownK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- Descendant · 2 generations on · 39 of its ownK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- Descendant · 3 generations on · 36 of its ownK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- Descendant · 3 generations on · 33 of its ownK100605 Mis SystemSpine Wave, Inc. · 2010
- Descendant · cites it directly · 27 of its ownK072183 ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc. · 2007
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K070245Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007 · cites it directly42descendants
- K081228Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008 · 2 generations on39descendants
- K083353Capsure (R) PS SystemSpine Wave, Inc. · 2008 · 3 generations on36descendants
- K100605Mis SystemSpine Wave, Inc. · 2010 · 3 generations on33descendants
- K072183ST360 Spinal Fixation System, Model 07.0029-7500.5600Zimmer Spine, Inc. · 2007 · cites it directly27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| −2 | K992276 | Modification to Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| −1 | K022374 | Cadence Spinal Fixation System | Sulzer Spine-Tech | 2002 | 1 |
| 0 (this device) | K041925 | ST360 Spinal Fixation System | Zimmer Spine, Inc. | 2004 | — |
| +1 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| +2 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| +3 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| +3 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| +1 | K072183 | ST360 Spinal Fixation System, Model 07.0029-7500.5600 | Zimmer Spine, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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…Classification: Class Ill; MNI, MNH, KWP, NKB Predicate Device: ST36OTM Spinal Fixation System (formerly Cadence) (K022374) Device Description: The ST36OTM Spinal Fixation System is a temporary implant system used to correct spinal deformity and to fac… | 2002 |
What descends from it? (83)
See all 834 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 |
|---|---|---|---|---|
| Oct 5, 2006 | Not classified | Z-0190-2007 | Other | Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K070245 (Spine Wave, Inc., 2007) has gone furthest, with 42 descendants of its own.
- 2 other devices also cite its predicate K022374.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
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 (200 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 sacrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041925: ST360 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/K041925
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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