510(k) · Cleared
ClearedVenus Facet Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Spine, Inc. · MRW System, Facet Screw Spinal Device
Cleared on Oct 19, 2012 as substantially equivalent to K052043 (Triage Medical, Inc., 2005) and 2 other predicates after a 259-day review. Its family tree reaches back 4 generations to 1997. 26 later devices descend from it.
- Decided
- Oct 19, 2012
- Review
- 259 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K953076 (1997). 12 ancestors in all. 26 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 3 generations backK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
- 2 generations backK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
- 1 generation backK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
- This deviceK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
- Descendant · cites it directly · 18 of its ownK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK211855 Ion Facet Screw SystemSurGenTec, LLC · 2022
- Descendant · 2 generations on · 9 of its ownK230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023
- Descendant · cites it directly · 8 of its ownK183589 PMT Facet ScrewProvidence Medical Technology, Inc. · 2019
- Descendant · 2 generations on · 7 of its ownK220951 PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · cites it directly18descendants
- K211855Ion Facet Screw SystemSurGenTec, LLC · 2022 · 2 generations on10descendants
- K230840PMT Facet Fixation System, Lumbar (PMT FFS-LX)Providence Medical Technology, Inc. · 2023 · 2 generations on9descendants
- K183589PMT Facet ScrewProvidence Medical Technology, Inc. · 2019 · cites it directly8descendants
- K220951PMT Facet Fixation System (PMT FFS)Providence Medical Technology, Inc. · 2022 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −3 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −2 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| −1 | K092568 | Spartan S3 Facet System | Amendia, Inc. | 2009 | — |
| 0 (this device) | K120340 | Venus Facet Screw System | Apollo Spine, Inc. | 2012 | — |
| +1 | K163374 | ALLY™ Facet Screws | Providence Medical Technology, Inc. | 2017 | — |
| +2 | K211855 | Ion Facet Screw System | SurGenTec, LLC | 2022 | — |
| +2 | K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | Providence Medical Technology, Inc. | 2023 | — |
| +1 | K183589 | PMT Facet Screw | Providence Medical Technology, Inc. | 2019 | — |
| +2 | K220951 | PMT Facet Fixation System (PMT FFS) | Providence Medical Technology, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K052043 | 3.8MM CS Facet Compression DeviceSummary page 2…e and is similar in terms of design, function, and materials used. Cleared devices include the Perpos Percutaneous Cervical Facet Screw Bone-Lok Implant® (Triage Medical K052043), the AmendiaTh Inc. Spartan S3 Facet System (K092568), and the X-spine Fixcet Spinal Facet Screw System (K100154). Device Desc… | 2005 |
| * | K092568 | Spartan S3 Facet SystemSummary page 2…erials used. Cleared devices include the Perpos Percutaneous Cervical Facet Screw Bone-Lok Implant® (Triage Medical K052043), the AmendiaTh Inc. Spartan S3 Facet System (K092568), and the X-spine Fixcet Spinal Facet Screw System (K100154). Device Description Device Identification: The Venu… | 2009 |
| * | K100154 | Fixcet Spinal Facet Screw SystemSummary page 2…Cervical Facet Screw Bone-Lok Implant® (Triage Medical K052043), the AmendiaTh Inc. Spartan S3 Facet System (K092568), and the X-spine Fixcet Spinal Facet Screw System (K100154). Device Description Device Identification: The Venus Facet Screw System consists of two separate diameter screw… | 2010 |
What descends from it? (26)
See all 264 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 15 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K163374 (Providence Medical Technology, Inc., 2017) has gone furthest, with 18 descendants of its own.
- 1 other device also cites its predicate K052043.
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. 2012, 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 Apollo Spine Venus Facet Screw 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 SI for 4.5mm and 5.5 mm screws. 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…
Read the full statement (175 words)
The Apollo Spine Venus Facet Screw 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 SI for 4.5mm and 5.5 mm screws. 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. The Apollo Venus Facet Screw System is indicated for treatment of any or all of the following:
* Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity
* Spondyldlisthesis
* Spondylolysis
* Degenerative disk disease (DDD) as defined by neck and/or back pain of discogenic origin as confinmed 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/K120340 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120340: Venus Facet Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120340
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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