510(k) · Cleared
ClearedSpinous Process Fusion (SPF) Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Simplicity, LLC · PEK Spinous Process Plate
Cleared on Jan 9, 2015 as substantially equivalent to K071877 (Lanx, LLC, 2007) and 7 other predicates after a 366-day review. Its family tree reaches back 8 generations to 1999. 9 later devices descend from it.
- Decided
- Jan 9, 2015
- Review
- 366 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 8 generations to K990745 (1999). 39 ancestors in all, the oldest K781443 (1978). 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 6 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 5 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 4 generations backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- 3 generations backK101471 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2010 · Recalled
- 2 generations backK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- 1 generation backK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- This deviceK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- Descendant · cites it directly · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- Descendant · 2 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- Descendant · cites it directly · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- Descendant · cites it directly · 5 of its ownK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
- Descendant · 2 generations on · 4 of its ownK211880 Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · cites it directly8descendants
- K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 2 generations on7descendants
- K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020 · cites it directly6descendants
- K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC · 2021 · cites it directly5descendants
- K211880Minuteman G5 MIS Fusion PlateSpinal Simplicity, LLC · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −7 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −6 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −5 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −4 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −3 | K101471 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2010 | 1 |
| −2 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| −1 | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| 0 (this device) | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| +1 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| +2 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
| +1 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020 | — |
| +1 | K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion… | Spinal Simplicity, LLC | 2021 | — |
| +2 | K211880 | Minuteman G5 MIS Fusion Plate | Spinal Simplicity, LLC | 2022 | — |
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 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (8)
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 |
|---|---|---|---|
| * | K071877 | Lanx Spinal Fixation SystemSummary page 5….3050 Spinal interlaminal fixation orthosis Class II Product code: PEK Predicate and Reference Devices Lanx Spinal Fixation System (Aspen) (K071877 – primary predicate) Globus SP-Fix Spinous Process Fixation Plate (K102195) X-Spine Axle Interspinous Fusion System… | 2007 |
| * | K102195 | SP-Fix Spinous Process Fixation PlateSummary page 5…code: PEK Predicate and Reference Devices Lanx Spinal Fixation System (Aspen) (K071877 – primary predicate) Globus SP-Fix Spinous Process Fixation Plate (K102195) X-Spine Axle Interspinous Fusion System (K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinou… | 2011 |
| * | K130438 | Axle Interspinous Fusion SystemSummary page 5…pinal Fixation System (Aspen) (K071877 – primary predicate) Globus SP-Fix Spinous Process Fixation Plate (K102195) X-Spine Axle Interspinous Fusion System (K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II… | 2013 |
| * | K133091 | Zip Mis Interspinous Fusion SystemSummary page 5…1877 – primary predicate) Globus SP-Fix Spinous Process Fixation Plate (K102195) X-Spine Axle Interspinous Fusion System (K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K13… | 2013 |
| * | K133052 | Affix (R) Next Gen Spinous Process Plate SystemSummary page 5…n Plate (K102195) X-Spine Axle Interspinous Fusion System (K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K132411) Alphatec Bridgepoint (K103205) Stryker Universe Pl… | 2013 |
| * | K132411 | Affix II Spinous Process Plate SystemSummary page 5…(K130438) Aurora Spine Zip (K133091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K132411) Alphatec Bridgepoint (K103205) Stryker Universe Plate (K132968) Intended Use / Indications for Use The Sp… | 2013 |
| * | K103205 | Bridgepoint Spinous Process Camp- Posterior Fixation SystemSummary page 5…33091) NuVasive Affix Next Gen Spinous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K132411) Alphatec Bridgepoint (K103205) Stryker Universe Plate (K132968) Intended Use / Indications for Use The Spinal Simplicity Spinous Process Fusion… | 2011 |
| * | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM)Summary page 5…inous Process Plate System (K133052) NuVasive Affix II Spinous Process Plate System (K132411) Alphatec Bridgepoint (K103205) Stryker Universe Plate (K132968) Intended Use / Indications for Use The Spinal Simplicity Spinous Process Fusion (SPF) Plate is a posterior, non-pedicle… | 2013 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151741 | HA Minuteman G3 MIS Fusion Plate | 2015 | 8 |
| K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | 2020 | 6 |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA… | 2021 | 5 |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA… | 2022 | 3 |
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 7 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 39 ancestors have a recall of any class.
- Of its descendants, K151741 (Spinal Simplicity, LLC, 2015) has gone furthest, with 8 descendants of its own.
- 17 other devices also cite its predicate K071877.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Spinal Simplicity Spinous Process Fusion (SPF) Plate 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 spinous processes for the purpose of achieving supplemental fusion in the following conditions: x degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history…
Read the full statement (111 words)
The Spinal Simplicity Spinous Process Fusion (SPF) Plate 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 spinous processes for the purpose of achieving supplemental fusion in the following conditions:
x degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic studies);
x spondylolisthesis;
x trauma (i.e., fracture or dislocation); and/or
x tumor.
The SPF-Plate is intended for use with bone graft material and is not intended for stand-alone use. The device may be implanted via an open (T1-S1) or percutaneous (L1-S1) approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140046 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140046: Spinous Process Fusion (SPF) Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140046
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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