510(k) · Cleared
ClearedCoflex-F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine, LLC · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Feb 13, 2012 as substantially equivalent to K093438 (Paradigm Spine, LLC, 2010) after a 159-day review. Its family tree reaches back 4 generations to 2003. 4 later devices descend from it.
- Decided
- Feb 13, 2012
- Review
- 159 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K032037 (2003). 7 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 3 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 2 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 1 generation backK093438 Paradigm Interspinous Fusion PlateParadigm Spine, LLC · 2010 · Recalled
- This deviceK112595 Coflex-FParadigm Spine, LLC · 2012
- Descendant · cites it directly · 2 of its ownK153302 coflex-IFParadigm Spine, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK232484 KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023
- Descendant · 2 generations on · 0 of its ownK201704 CoFix SystemParadigm Spine GmbH · 2020
- Descendant · cites it directly · 0 of its ownK160568 Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016
Most influential descendants
Showing 4 of 4 · See all- K153302coflex-IFParadigm Spine, LLC · 2016 · cites it directly2descendants
- K232484KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023 · 2 generations on0descendants
- K201704CoFix SystemParadigm Spine GmbH · 2020 · 2 generations on0descendants
- K160568Precision Spine Interspinous Plate SystemPrecision Spine, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −3 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −2 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −1 | K093438 | Paradigm Interspinous Fusion Plate | Paradigm Spine, LLC | 2010 | 1 |
| 0 (this device) | K112595 | Coflex-F | Paradigm Spine, LLC | 2012 | — |
| +1 | K153302 | coflex-IF | Paradigm Spine, LLC | 2016 | — |
| +2 | K232484 | KeyLift™ Expandable Interlaminar Stabilization System | Flospine | 2023 | — |
| +2 | K201704 | CoFix System | Paradigm Spine GmbH | 2020 | — |
| +1 | K160568 | Precision Spine Interspinous Plate System | Precision Spine, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K093438 | Paradigm Interspinous Fusion PlateSummary page 2…Predicate Device(s): The modified coflex-F Short is substantially equivalent to the predicate coflex-F Implant (Paradigm Interspinous Fusion Plate) previously cleared in K093438 with respect to indications, design, function, and materials. Substantial Equivalence: Finite element analysis and engineering r… | 2010 |
What descends from it? (4)
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 9 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K153302 (Paradigm Spine, LLC, 2016) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K093438.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The coflex-F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (Li-Si). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112595 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112595: Coflex-F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112595
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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