510(k) · Cleared
ClearedSpine-Tech Silhouette Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine-Tech, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jul 29, 1998 after a 184-day review. The FDA summary names its predicate without a number. 1 of the 960 devices in its family, counting itself, has a Class I recall. 959 later devices descend from it.
- Decided
- Jul 29, 1998
- Review
- 184 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
959 later devices descend from it, 7 citing it directly. 1 of the 960 devices in this family, counting this one, has a Class I recall.
- This deviceK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- Descendant · cites it directly · 902 of its ownK031511 Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · 2 generations on · 834 of its ownK043565 Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 822 of its ownK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · Recalled
- Descendant · 3 generations on · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
Showing 5 of 959 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 959 · See all- K031511Dynesys Spinal SystemCenterpulse Spine-Tech, Inc. · 2004 · cites it directly902descendants
- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on870descendants
- K043565Modification to Dynesys Spinal SystemZimmer Spine, Inc. · 2005 · 2 generations on834descendants
- K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · 3 generations on822descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 3 generations on821descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| +1 | K031511 | Dynesys Spinal System | Centerpulse Spine-Tech, Inc. | 2004 | 4 |
| +2 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +2 | K043565 | Modification to Dynesys Spinal System | Zimmer Spine, Inc. | 2005 | 1 |
| +3 | K060615 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | 34 |
| +3 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 0 |
| 2009 | 14 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 33 | 0 |
| 2013 | 46 | 0 |
| 2014 | 45 | 0 |
| 2015 | 52 | 0 |
| 2016 | 52 | 0 |
| 2017 | 52 | 0 |
| 2018 | 54 | 0 |
| 2019 | 47 | 0 |
| 2020 | 63 | 0 |
| 2021 | 58 | 1 |
| 2022 | 69 | 0 |
| 2023 | 88 | 0 |
| 2024 | 79 | 0 |
| 2025 | 73 | 0 |
| 2026 | 67 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | — | Depuy Motech MOSS Miami Spinal System Named without a submission number | |
| * | — | Sofamor Danek Multi Axial Screw Named without a submission number | |
| * | — | Sofamor Danek TSRII™ Spinal System Named without a submission number | |
| * | — | Wright Medical Technology Wrightlock™ Spinal System Named without a submission number | |
| * | — | Wright Medical Technology Versalok™ Low Back Fixation System Named without a submission number |
What descends from it? (959)
See all 9597 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031511 | Dynesys Spinal System | 2004 | 902 |
| K992276 | Modification to Silhouette Spinal Fixation System | 1999 | 171 |
| K022374 | Cadence Spinal Fixation System | 2002 | 84 |
| K042702 | Silhouette Spinal Fixation System | 2004 | 4 |
| K143683 | APEX-DL Spine System | 2015 | 3 |
| K020196 | Modification to Silhouette Spinal Fixation System | 2002 | 0 |
| K012173 | Device Modification of Silhouette Spindal Fixation System | 2001 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K031511 (Centerpulse Spine-Tech, Inc., 2004) has gone furthest, with 902 descendants of its own.
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 Spine-Tech Sithouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joing b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of 2 solid fision mass. When used for this indication, the…
Read the full statement (231 words)
The Spine-Tech Sithouette Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joing b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of 2 solid fision mass. When used for this indication, the fusion mass may not go above the 1.5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.
When used as 2 hook and sacral screw system, the Spine-Tech Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic vrigin with degeneration of the disc confirmed by a 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 far this indication, screws of the Spine-Tech Silhouette Spinal Fixation System are intended for sacral/iliac attachment only. Hook and transverse comnectors 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 T1 to the sacrum.
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/K980288 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980288: Spine-Tech Silhouette Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980288
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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