510(k) · Cleared
ClearedModification to Silhouette Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Spine-Tech · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 1, 1999 as substantially equivalent to K980288 (Spine-Tech, Inc., 1998) after an 86-day review. Its family tree reaches back 1 generation to 1998. 171 later devices descend from it.
- Decided
- Oct 1, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980288 (1998). 171 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- This deviceK992276 Modification to Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- Descendant · cites it directly · 111 of its ownK993067 Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999
- Descendant · 2 generations on · 100 of its ownK072022 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007
- Descendant · cites it directly · 84 of its ownK022374 Cadence Spinal Fixation SystemSulzer Spine-Tech · 2002 · Recalled
- Descendant · 2 generations on · 83 of its ownK041925 ST360 Spinal Fixation SystemZimmer Spine, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 43 of its ownK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K993067Silhouette Spinal Fixation SystemSulzer Spine-Tech · 1999 · cites it directly111descendants
- K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007 · 2 generations on100descendants
- K022374Cadence Spinal Fixation SystemSulzer Spine-Tech · 2002 · cites it directly84descendants
- K041925ST360 Spinal Fixation SystemZimmer Spine, Inc. · 2004 · 2 generations on83descendants
- K121115M.U.S.T Pedicle Screw SystemMedacta International · 2012 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980288 | Spine-Tech Silhouette Spinal Fixation System | Spine-Tech, Inc. | 1998 | — |
| 0 (this device) | K992276 | Modification to Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| +1 | K993067 | Silhouette Spinal Fixation System | Sulzer Spine-Tech | 1999 | — |
| +2 | K072022 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2007 | — |
| +1 | K022374 | Cadence Spinal Fixation System | Sulzer Spine-Tech | 2002 | 1 |
| +2 | K041925 | ST360 Spinal Fixation System | Zimmer Spine, Inc. | 2004 | 1 |
| +3 | K121115 | M.U.S.T Pedicle Screw System | Medacta International | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 9 | 0 |
| 2015 | 10 | 0 |
| 2016 | 12 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 16 | 0 |
| 2021 | 8 | 0 |
| 2022 | 6 | 0 |
| 2023 | 16 | 0 |
| 2024 | 15 | 0 |
| 2025 | 7 | 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 MNI? 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 |
|---|---|---|---|
| * | K980288 | Spine-Tech Silhouette Spinal Fixation SystemSummary page 1…lolisthesis Spinal Fixation Device System Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis Class I Silhouette™ Spinal Fixation System K 980288, concurrence date July 29, 1998 The Silhouette™ Spinal Fixation System is a temporary implant system used to correct spinal defo… | 1998 |
What descends from it? (171)
See all 1714 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?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 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 neurologic impairment, fracture, dislocation, scoliosis…
Read the full statement (271 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 neurologic 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 receiving fusions with autogenous graft only
c) who are having the device fixed or attached to the lumbar or sacral spine
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 disease (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 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/K992276 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992276: Modification to 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/K992276
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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