510(k) · Cleared
ClearedWiltrom Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiltrom Corporation Limited · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jan 12, 2018 as substantially equivalent to K090224 (X-Spine Systems, Inc., 2009) after a 142-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Jan 12, 2018
- Review
- 142 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052847 (2005). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK052847 Capless Pedicle Screw SystemX-Spine Systems, Inc. · 2005
- 1 generation backK090224 Fortex Pedicle Screw SystemX-Spine Systems, Inc. · 2009
- This deviceK172548 Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2018
- Descendant · cites it directly · 0 of its ownK202894 Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2020
Most influential descendants
Showing 1 of 1 · See all- K202894Wiltrom Spinal Fixation SystemWiltrom Corporation Limited · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052847 | Capless Pedicle Screw System | X-Spine Systems, Inc. | 2005 | — |
| −1 | K090224 | Fortex Pedicle Screw System | X-Spine Systems, Inc. | 2009 | — |
| 0 (this device) | K172548 | Wiltrom Spinal Fixation System | Wiltrom Corporation Limited | 2018 | — |
| +1 | K202894 | Wiltrom Spinal Fixation System | Wiltrom Corporation Limited | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K090224 | Fortex Pedicle Screw SystemSummary page 4…8.3070 Product Code / Device Class NKB / Class II 510(k) Review Panel Orthopedic III. Primary Predicate Device Fortex Pedicle Screw System (K090224) K172548… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202894 | Wiltrom Spinal Fixation System | 2020 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K202894 (Wiltrom Corporation Limited, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090224.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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 Wiltrom Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or
deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra;
degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis;
kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172548: Wiltrom 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/K172548
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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