510(k) · Cleared
ClearedFacet Screw System
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 Feb 28, 2013 as substantially equivalent to K101284 (Nuvasive, Inc., 2010) and 1 other predicate after a 107-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Feb 28, 2013
- Review
- 107 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K994308 (2000). 10 ancestors in all, the oldest K953076 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK994308 Nuvasive Townley Facet ScrewNuvasive, Inc. · 2000
- 4 generations backK012773 Discovery Facet Screw Fixation SystemDepuyacromed · 2001
- 3 generations backK071420 Chameleon Fixation SystemSpinefrontier, Inc. · 2008 · Recalled
- 2 generations backK092464 Spineology Facet ScrewSpineology, Inc. · 2009
- 1 generation backK101284 Facet Screw SystemNuvasive, Inc. · 2010
- This deviceK123497 Facet Screw SystemFacet-Link, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK150223 Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150223Facet-Link Stabilization PlatformFacet-Link, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994308 | Nuvasive Townley Facet Screw | Nuvasive, Inc. | 2000 | — |
| −4 | K012773 | Discovery Facet Screw Fixation System | Depuyacromed | 2001 | — |
| −3 | K071420 | Chameleon Fixation System | Spinefrontier, Inc. | 2008 | 1 |
| −2 | K092464 | Spineology Facet Screw | Spineology, Inc. | 2009 | — |
| −1 | K101284 | Facet Screw System | Nuvasive, Inc. | 2010 | — |
| 0 (this device) | K123497 | Facet Screw System | Facet-Link, Inc. | 2013 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K101284 | Facet Screw SystemSummary page 1…cet Screw Spinal Device System Classification: Unclassified Product Code: MRW Predicate Device: NuVasive Facet Screw System (K 10 1284) Depuy Discovery Facet Screw Fixation System (KO 12773) Intended Use / Indications for Use: The… | 2010 |
| * | K012773 | Discovery Facet Screw Fixation System | 2001 |
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 |
|---|---|---|---|
| K150223 | Facet-Link Stabilization Platform | 2015 | 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 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K150223 (Facet-Link, Inc., 2015) has gone furthest, with 0 descendants of its own.
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. 2013, 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 Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are: Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle. Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through…
Read the full statement (167 words)
The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are:
Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.
The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S51 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:
(a) pseudoarthrosis and failed previous fusion;
(b) spondylofisthesis; and
(c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.
The Facet-Link Facet Screw System is intended for conventional surgical placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123497: Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123497
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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