510(k) · Cleared
ClearedSilhouette Spinal Fixation System
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 Nov 23, 2004 as substantially equivalent to K980288 (Spine-Tech, Inc., 1998) after a 54-day review. Its family tree reaches back 1 generation to 1998. 4 later devices descend from it.
- Decided
- Nov 23, 2004
- Review
- 54 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980288 (1998). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980288 Spine-Tech Silhouette Spinal Fixation SystemSpine-Tech, Inc. · 1998
- This deviceK042702 Silhouette Spinal Fixation SystemZimmer Spine, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK111301 Instinct Java SystemZimmer Spine · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK113270 Instinct Java SystemZimmer Spine · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK123552 Instinct Java SystemZimmer Spine · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK122592 Instinct Java SystemZimmer Spine · 2013 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K111301Instinct Java SystemZimmer Spine · 2011 · cites it directly3descendants
- K113270Instinct Java SystemZimmer Spine · 2011 · 2 generations on2descendants
- K123552Instinct Java SystemZimmer Spine · 2013 · 2 generations on0descendants
- K122592Instinct Java SystemZimmer Spine · 2013 · 2 generations on0descendants
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) | K042702 | Silhouette Spinal Fixation System | Zimmer Spine, Inc. | 2004 | — |
| +1 | K111301 | Instinct Java System | Zimmer Spine | 2011 | 1 |
| +2 | K113270 | Instinct Java System | Zimmer Spine | 2011 | 1 |
| +2 | K123552 | Instinct Java System | Zimmer Spine | 2013 | 1 |
| +2 | K122592 | Instinct Java System | Zimmer Spine | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 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? (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…ame: Spinal interlaminal fixation orthosis Pedicle screw spinal system Predicate Devices: SilhouetteTM Spinal Fixation System (K980288) Description of Device: The Zimmer Spine Silhouette Spinal Fixation System is a temporary implant system used to correct spina… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111301 | Instinct Java System | 2011 | 3 |
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 NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SilhouetteTM Spinal System is intended for posterior, noncervical 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 and dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.…
Read the full statement (196 words)
The SilhouetteTM Spinal System is intended for posterior, noncervical 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 and dislocation); spinal stenosis; deformities (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 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 SilhouetteTM 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 the hook and sacral screw fixation of this system are T1 to the sacrum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042702: 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/K042702
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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