510(k) · Cleared
ClearedKeyLift™ Expandable Interlaminar Stabilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flospine · PEK Spinous Process Plate
Cleared on Oct 19, 2023 as substantially equivalent to K153302 (Paradigm Spine, LLC, 2016) and 1 other predicate after a 64-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Oct 19, 2023
- Review
- 64 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K990745 (1999). 31 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 5 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 4 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 3 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 2 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- 1 generation backK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
- This deviceK232484 KeyLift™ Expandable Interlaminar Stabilization SystemFlospine · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −6 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −5 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −4 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −3 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −2 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| −1 | K130438 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2013 | 1 |
| 0 (this device) | K232484 | KeyLift™ Expandable Interlaminar Stabilization System | Flospine | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K153302 | coflex-IFSummary page 4…erlaminal fixation orthosis Classification Code: PEK Classification Panel: Orthopedic Regulation Number: 21 CFR sections 888.3050 PRIMARY PREDICATE DEVICE K153302 Paradigm Spine Coflex-IF ADDITIONAL PREDICATE DEVICE K130438 X-spine Axle lnterspinous Fusion… | 2016 |
| * | K130438 | Axle Interspinous Fusion SystemSummary page 4…Orthopedic Regulation Number: 21 CFR sections 888.3050 PRIMARY PREDICATE DEVICE K153302 Paradigm Spine Coflex-IF ADDITIONAL PREDICATE DEVICE K130438 X-spine Axle lnterspinous Fusion System… | 2013 |
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 24 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 31 ancestors have a recall of any class.
- 1 other device also cites its predicate K153302.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with…
Read the full statement (101 words)
The FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLift™ Expandable Interlaminar Stabilization System is intended for use with allograft or autograft bone and is not intended for stand-alone use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232484: KeyLift™ Expandable Interlaminar Stabilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232484
Report an extraction error
Are you the manufacturer?
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