510(k) · Cleared
ClearedTyphoon (TM) Facet Screw Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choicespine, LP · MRW System, Facet Screw Spinal Device
Cleared on Sep 20, 2012 as substantially equivalent to K012773 (Depuyacromed, 2001) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Sep 20, 2012
- Review
- 87 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K994308 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 3 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 2 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 1 generation backK100154 Fixcet Spinal Facet Screw SystemX-Spine Systems, Inc. · 2010
- This deviceK121850 Typhoon (TM) Facet Screw Fixation SystemChoicespine, LP · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −3 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −2 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −1 | K100154 | Fixcet Spinal Facet Screw System | X-Spine Systems, Inc. | 2010 | — |
| 0 (this device) | K121850 | Typhoon (TM) Facet Screw Fixation System | Choicespine, LP | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 MRW? 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 MRW device
- #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K012773 | Discovery Facet Screw Fixation SystemSummary page 1…lassification and Common Name Unclassified, Facet Screw Spinal Device System Device Product Code M RW Predicates DePuy AcroMed m Inc. -Discovery"M Facet Screw System (K012773) Spine Frontier Inc. -Chameleon'" Fixation Screw System (K071420) X-Spine Systems, Inc. - Fixcet M Spinal Facet Screw Fixation Sy… | 2001 |
| * | K071420 | Chameleon Fixation SystemSummary page 1…vice System Device Product Code M RW Predicates DePuy AcroMed m Inc. -Discovery"M Facet Screw System (K012773) Spine Frontier Inc. -Chameleon'" Fixation Screw System (K071420) X-Spine Systems, Inc. - Fixcet M Spinal Facet Screw Fixation System (1100154) Device Description The Typhoon Facet Fixation Sys… | 2008 |
| * | K100154 | Fixcet Spinal Facet Screw SystemSummary page 1…ery"M Facet Screw System (K012773) Spine Frontier Inc. -Chameleon'" Fixation Screw System (K071420) X-Spine Systems, Inc. - Fixcet M Spinal Facet Screw Fixation System (1100154) Device Description The Typhoon Facet Fixation System is a posterior Facet spinal fixation system consisting of screws… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 13 other devices also cite its predicate K012773.
How does its category compare?
All MRW devicesMRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MRW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRW
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRW
3in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRW
3in 2025
MAUDE reports naming product code MRW, 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 | 0 | — | 0 | 1 |
| 2008 | 3 | 88 | 0 | 0 |
| 2009 | 6 | 89 | 0 | 2 |
| 2010 | 6 | 108 | 0 | 7 |
| 2011 | 3 | 122 | 3 | 62 |
| 2012 | 4 | 119 | 0 | 6 |
| 2013 | 7 | 110 | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 0 | 4 |
| 2019 | 3 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 3 | 252 | 0 | 0 |
| 2023 | 3 | 190 | 0 | 1 |
| 2024 | 7 | 50 | 0 | 2 |
| 2025 | 7 | 97 | 0 | 3 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
The Typhoon t " Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from Li to Si inclusive. The TyphoonTm Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of disco~genic origin as confirmed by patient history…
Read the full statement (140 words)
The Typhoon t " Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from Li to Si inclusive.
The TyphoonTm Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of disco~genic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudloarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations.
For transfacet fixation, the Typhoon m Facet Screw Fixation System is inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121850: Typhoon (TM) Facet Screw 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/K121850
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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