510(k) · Cleared
Clearedcoflex-IF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Spine, LLC · PEK Spinous Process Plate
Cleared on Sep 8, 2016 as substantially equivalent to K112595 (Paradigm Spine, LLC, 2012) and 3 other predicates after a 300-day review. Its family tree reaches back 5 generations to 2003. 2 later devices descend from it.
- Decided
- Sep 8, 2016
- Review
- 300 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K032037 (2003). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 4 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 2 generations backK093438 Paradigm Interspinous Fusion PlateParadigm Spine, LLC · 2010 · Recalled
- 1 generation backK112595 Coflex-FParadigm Spine, LLC · 2012
- This deviceK153302 coflex-IFParadigm Spine, LLC · 2016
- Descendant · cites it directly · 0 of its ownK232484 KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023
- Descendant · cites it directly · 0 of its ownK201704 CoFix SystemParadigm Spine GmbH · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −4 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −2 | K093438 | Paradigm Interspinous Fusion Plate | Paradigm Spine, LLC | 2010 | 1 |
| −1 | K112595 | Coflex-F | Paradigm Spine, LLC | 2012 | — |
| 0 (this device) | K153302 | coflex-IF | Paradigm Spine, LLC | 2016 | — |
| +1 | K232484 | KeyLift™ Expandable Interlaminar Stabilization System | Flospine | 2023 | — |
| +1 | K201704 | CoFix System | Paradigm Spine GmbH | 2020 | — |
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 |
|---|---|---|
| 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 PEK? 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 PEK device
- #1 K253250 Minuteman® G6 MIS Fusion Platescore 15.2 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K112595 | Coflex-FSummary page 4…CFR §888.3050, Spinal Interlaminal Fixation Orthosis Class: II Product Code: PEK Primary Predicate: coflex-F system (K112595, K093438) Additional Predicates: Lanx ASPEN (K071877) NuVasive Affix (K073278) Indications… | 2012 |
| * | K093438 | Paradigm Interspinous Fusion PlateSummary page 4…3050, Spinal Interlaminal Fixation Orthosis Class: II Product Code: PEK Primary Predicate: coflex-F system (K112595, K093438) Additional Predicates: Lanx ASPEN (K071877) NuVasive Affix (K073278) Indications For Use:… | 2010 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 4…II Product Code: PEK Primary Predicate: coflex-F system (K112595, K093438) Additional Predicates: Lanx ASPEN (K071877) NuVasive Affix (K073278) Indications For Use: The coflex-IF is a posterior, non-pedicle supplemen… | 2007 |
| * | K073278 | Spinous Process Plate SystemSummary page 4…PEK Primary Predicate: coflex-F system (K112595, K093438) Additional Predicates: Lanx ASPEN (K071877) NuVasive Affix (K073278) Indications For Use: The coflex-IF is a posterior, non-pedicle supplemental fixation device intended for use with an interbody… | 2008 |
What descends from it? (2)
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 13 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K232484 (Flospine, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112595.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PEK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEK
60in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PEK
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEK
3in 2025
MAUDE reports naming product code PEK, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 10 | 118 | 0 | 0 |
| 2014 | 8 | 120 | 0 | 2 |
| 2015 | 6 | 166 | 0 | 3 |
| 2016 | 4 | 176 | 0 | 0 |
| 2017 | 3 | 94 | 0 | 0 |
| 2018 | 4 | 69 | 0 | 2 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 2 | — | 1 | 17 |
| 2022 | 3 | 135 | 0 | 11 |
| 2023 | 4 | 60 | 0 | 8 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The coflex-IF 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 (L1 - S1). 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/K153302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153302: coflex-IF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153302
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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