510(k) · Cleared
ClearedFacet-Link Stabilization Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Facet-Link, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Apr 28, 2015 as substantially equivalent to K123497 (Facet-Link, Inc., 2013) after an 88-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Apr 28, 2015
- Review
- 88 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K994308 (2000). 11 ancestors in all, the oldest K953076 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 5 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 4 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 3 generations backK092464 Spineology Facet ScrewSpineology, Inc. · 2009
- 2 generations backK101284 Facet Screw SystemNuvasive, Inc. · 2010
- 1 generation backK123497 Facet Screw SystemFacet-Link, Inc. · 2013
- This deviceK150223 Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −5 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −4 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −3 | K092464 | Spineology Facet Screw | Spineology, Inc. | 2009 | — |
| −2 | K101284 | Facet Screw System | Nuvasive, Inc. | 2010 | — |
| −1 | K123497 | Facet Screw System | Facet-Link, Inc. | 2013 | — |
| 0 (this device) | K150223 | Facet-Link Stabilization Platform | Facet-Link, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K123497 | Facet Screw SystemSummary page 4…n: Unclassified Product Code: MRW Predicate and Reference Devices: Primary Predicate Device: Facet-Link, Inc.’s Facet Screw System (K123497) Reference Devices: Medtronic Sofamor Danek’s TOWNLEY Transfacetpedicular Screw Fixation System (K013829); Medtronic Sofamor Dane… | 2013 |
| † | K013829 | Modification to Townley Transfacetpedicular Screw Fixation System | 2001 |
| † | K081080 | TSRH Spinal System | 2008 |
| † | K002082 | Speedlink Transverse Connector | 2000 |
| † | K070300 | Expedium SFX Cross Connector System | 2007 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
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. 2015, 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 Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following: 1. Spondylolisthesis. 2. Degenerative disc disease (DDD) as defined…
Read the full statement (140 words)
The Facet-Link Stabilization Platform is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The system is indicated for use with bone graft, at single or multiple levels, from C2 to S1 (inclusive) for the Facet Screws and L3 to S1 (inclusive) for MINI and HEMI devices. The Platform is indicated for the treatment of any or all of the following:
1. Spondylolisthesis.
2. Degenerative disc disease (DDD) as defined as back pain of discogenic origin as confirmed by radiographic studies.
3. Degeneration of the facets with instability.
The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:
1. Pseudoarthrosis and failed previous fusion;
2. Spondylolisthesis; and
3. Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150223 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150223: Facet-Link Stabilization Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150223
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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