510(k) · Cleared
ClearedSilhouette Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Spine-Tech · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 16, 1999 as substantially equivalent to K992276 (Sulzer Spine-Tech, 1999) after a 64-day review. Its family tree reaches back 2 generations to 1998. 111 later devices descend from it.
- Decided
- Nov 16, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980288 (1998). 111 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- 1 generation backK992276 Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- This deviceK993067 Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- Descendant · cites it directly · 100 of its ownK072022 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007
- Descendant · 2 generations on · 43 of its ownK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
- Descendant · 2 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · 3 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 2 generations on · 28 of its ownK132878 M.U.S.T. ExtensionMedacta International · 2013
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 111 · See all- K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007 · cites it directly100descendants
- K121115M.U.S.T Pedicle Screw SystemMedacta International · 2012 · 2 generations on43descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · 2 generations on30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 3 generations on29descendants
- K132878M.U.S.T. ExtensionMedacta International · 2013 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| −1 | K992276 | Modification to Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| 0 (this device) | K993067 | Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| +1 | K072022 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2007 | — |
| +2 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
| +2 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +3 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +2 | K132878 | M.U.S.T. Extension | Medacta International | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 5 | 0 |
| 2026 | 12 | 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 |
|---|---|---|---|
| * | K992276 | Modification to Silhouette Spinal Fixation System Cleared while this submission was under review Summary page 1…ory Affairs Specialist Silhouette™ Spinal Fixation System Rod, hook, and screw spinal instrumentation Class II, KWP, MNI, and MNH Stlhouette™ Spinal Fixation System K992276 (concurrence date October 1, 1999) Device Description: The Sithouette™ Spinal Fixation System is a temporary implant system use… | 1999 |
What descends from it? (111)
See all 1113 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 1 year and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072022 (Amedica Corp., 2007) has gone furthest, with 100 descendants of its own.
- 3 other devices also cite its predicate K992276.
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?
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of meurologic impairment, fracture, dislocation, scoliosis…
Read the full statement (272 words)
When used as a pedicle screw fixation system in skeletally mature patients, the Silhouette™ Spinal Fixation System is intended to provide 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of meurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis}.
In addition, when used as a pedicle screw fixation system, the Silhouette™ Spinal Fixation System is indicated for use in patients:
a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 joint
b) who are recciving fusions with autogenous graft only
¢) who are having the device fixed or attached to the lumbar or sacral spinc, and
d) who are having the device removed after the development of a solid fusion mass
When used as a hook and sacral screw system, the Silhouette™ Spinal Fixation System is intended for use in the treatment of degenerative disc discase (as defined by 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 Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use ouly. 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/K993067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993067: Silhouette 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/K993067
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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