510(k) · Decided
DecidedPerpos FCD-2 System (Single Patient Use), Anchor, Stabilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interventional Spine, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Jun 11, 2009 as substantially equivalent to K082795 (Interventional Spine, Inc., 2008) after an 80-day review. Its family tree reaches back 4 generations to 2002. 3 later devices descend from it.
- Decided
- Jun 11, 2009
- Review
- 80 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020411 (2002). 8 ancestors in all, the oldest K953076 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK020411 Nuvasive Triad Facet Screw SystemNuvasive, Inc. · 2002
- 3 generations backK043351 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S…Triage Medical, Inc. · 2005 · Recalled
- 2 generations backK062391 Disposable Posterior Lumbar Stabilization Procedure Kit, Models…Triage Medical, Inc. · 2006 · Recalled
- 1 generation backK082795 Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantInterventional Spine, Inc. · 2008
- This deviceK090767 Perpos FCD-2 System (Single Patient Use), Anchor, StabilizerInterventional Spine, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK101762 Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK192281 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System…Medos International SARL · 2019
- Descendant · cites it directly · 0 of its ownK110170 Raptor Facet Fixation SystemAlphatec Spine, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K101762Viper F2 Facet Fixation SystemDepuy Spine, Inc. · 2010 · cites it directly1descendant
- K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL · 2019 · 2 generations on0descendants
- K110170Raptor Facet Fixation SystemAlphatec Spine, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020411 | Nuvasive Triad Facet Screw System | Nuvasive, Inc. | 2002 | — |
| −3 | K043351 | 4.5MM Bone-Lok Facet Screw, Models TFCD-45-3040S or N; SFCD-45-3040S or N | Triage Medical, Inc. | 2005 | 1 |
| −2 | K062391 | Disposable Posterior Lumbar Stabilization Procedure Kit, Models 9045-01 and… | Triage Medical, Inc. | 2006 | 1 |
| −1 | K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS Implant | Interventional Spine, Inc. | 2008 | — |
| 0 (this device) | K090767 | Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer | Interventional Spine, Inc. | 2009 | — |
| +1 | K101762 | Viper F2 Facet Fixation System | Depuy Spine, Inc. | 2010 | — |
| +2 | K192281 | AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior… | Medos International SARL | 2019 | — |
| +1 | K110170 | Raptor Facet Fixation System | Alphatec Spine, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K082795 | Single Use Perpos PLS System, 4.5 Bone-Lok PLS ImplantSummary page 1…rthopedic, General, and Plastic Surgery Device Class: Unclassified PREDICATE DEVICES PERpOSTM PLS System previously cleared under 51 0(k) K082795 DEVICE-DESCRIP-TION _____ The PERPOS Tm FCD-2… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K101762 (Depuy Spine, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K082795.
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. 2009, 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 PERPOSTM FCD-2 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 PERPOS M T FCD-2 is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS FCD-2 may be used…
Read the full statement (154 words)
The PERPOSTM FCD-2 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 PERPOS M T FCD-2 is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The PERPOSTM FCD-2 is intended for lumbar bilateral facet fixation, with bone graft, at single or multiple levels from Li to SI. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOSTM FCD-2 Anchor and Stabilizer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090767: Perpos FCD-2 System (Single Patient Use), Anchor, Stabilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090767
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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