510(k) · Cleared
Recalled · 2011Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triage Medical, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Sep 14, 2006 as substantially equivalent to K043351 (Triage Medical, Inc., 2005) after a 29-day review. Its family tree reaches back 2 generations to 2002. 9 later devices descend from it. It has been recalled once.
- Decided
- Sep 14, 2006
- Review
- 29 days
- Class
- Class U
- Product code
- MRW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020411 (2002). 9 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- 1 generation backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
- This deviceK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK102438 Primalok Facet Fixation SystemOsteomed LP · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK240085 zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK101762 Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082795Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008 · cites it directly8descendants
- K102438Primalok Facet Fixation SystemOsteomed LP · 2010 · 2 generations on4descendants
- K090767Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009 · 2 generations on3descendants
- K240085zLOCK Lumbar Facet Fixation SystemZygofix, Ltd. · 2024 · 3 generations on2descendants
- K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| −1 | K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N | Triage Medical, Inc. | 2005 | 1 |
| 0 (this device) | K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and… | Triage Medical, Inc. | 2006 | — |
| +1 | K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant | Interventional Spine, Inc. | 2008 | — |
| +2 | K102438 | Primalok Facet Fixation System | Osteomed LP | 2010 | 1 |
| +2 | K090767 | Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer | Interventional Spine, Inc. | 2009 | — |
| +3 | K240085 | zLOCK Lumbar Facet Fixation System | Zygofix, Ltd. | 2024 | — |
| +3 | K101762 | Viper F2 Facet Fixation System | Depuy Spine, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or NSummary page 1…tabilization Procedure Kit is similar in design and intended use to the Triage Medical BONE-LOK® 4.5mm Facet Screw and BONE-LOK®I FS Instrument Kit cleared under 51 0(k) K04335 1. DEVICE DESCRIPTION The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure… | 2005 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant | 2008 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2011 | Not classified | Z-3033-2011 | Other | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082795 (Interventional Spine, Inc., 2008) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K043351.
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.
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 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm Facet Compression Device is to stabilize…
Read the full statement (143 words)
The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from LI to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062391: Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and 9045-02; Compression Tool, Model 6113-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062391
Report an extraction error
Are you the manufacturer?
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