510(k) · Cleared
ClearedFacetBRIDGE® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ldr Spine USA, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Aug 4, 2016 as substantially equivalent to K152137 (Ldr Spine USA, 2016) after a 35-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Aug 4, 2016
- Review
- 35 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K953076 (1997). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 5 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 4 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 3 generations backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- 2 generations backK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- 1 generation backK152137 FacetBRIDGE SystemLdr Spine USA · 2016
- This deviceK161798 FacetBRIDGE® SystemLdr Spine USA, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −5 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −4 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −3 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| −2 | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| −1 | K152137 | FacetBRIDGE System | Ldr Spine USA | 2016 | — |
| 0 (this device) | K161798 | FacetBRIDGE® System | Ldr Spine USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K152137 | FacetBRIDGE SystemSummary page 4…n: Unclassified Predicate Devices: Primary Predicate: FacetBRIDGE® System – Facet Screws (K152137, LDR Spine 1/25/2016) Device Description: The FacetBRIDGE® System is a set of screw… | 2016 |
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 19 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 15 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. 2016, 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 FacetBRIDGE® 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 C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the…
Read the full statement (183 words)
The FacetBRIDGE® 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 C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly 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 pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
• Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity,
• Spondylolisthesis,
• Spondylolysis,
• Degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies,
• Degeneration of the facets with instability,
• Trauma including spinal fractures and/or dislocations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161798 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161798: FacetBRIDGE® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161798
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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