510(k) · Cleared
ClearedKompreda
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Custom Spine, Inc. · MRW System, Facet Screw Spinal Device
Cleared on May 3, 2013 as substantially equivalent to K073515 (Trans1 Incorporated, 2008) after a 430-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 3, 2013
- Review
- 430 days
- Class
- Class U
- Product code
- MRW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953076 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −2 | K051856 | TRANS1 Facet Screws | Trans1 Incorporated | 2005 | — |
| −1 | K073515 | TRANS1 Facet Screw | Trans1 Incorporated | 2008 | — |
| 0 (this device) | K120597 | Kompreda | Custom Spine, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K073515 | TRANS1 Facet ScrewSummary page 1…ommon Name: Facet Screw System Device Classification: Unclassified Reason Unclassified: Pre-amiendment Device Product Codes: MRW Predicate Devices Trans I facet screw (K073515S), Depuy Spine's DISCOVERY facet screw system (KG 12773) Device Description The subject Kompresa Facet Screw System consist of… | 2008 |
| Kept off the family tree | K012773 | FDA’s K012773 is Discovery Facet Screw Fixation System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
- None of the 4 ancestors has a recall.
- 10 other devices also cite its predicate K073515.
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 Kompresa Facet Screw System is indicated for bilateral transfacet fixation and
stabilization of the facet joints as an aid to fusion for the treatment of any or all of the
following at the T10 to S1 (included) spinal levels:
* Trauma, including spinal fractures and/or dislocation
Spondylolisthesis
Spondylolysis
* Pseudoarthrosis or failed previous fusions which are symptomatic or which may
cause secondary instability or deformity
* Degenerative disc disease (defined as back pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies).
* Degeneration of the facets with instability
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120597 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120597: Kompreda.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120597
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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