510(k) · Cleared
ClearedUnivise Spinous Process Fixation Plate (35MM, 40MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Spine · PEK Spinous Process Plate
Cleared on Nov 18, 2013 as substantially equivalent to K131238 (Nuvasive, Inc., 2013) and 1 other predicate after a 56-day review. Its family tree reaches back 7 generations to 1999. 12 later devices descend from it.
- Decided
- Nov 18, 2013
- Review
- 56 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K990745 (1999). 32 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 2 citing it directly.
- 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 backK122509 Vertiflex Spinous Process Fixation PlateVertiflex, Inc. · 2012
- This deviceK132968 Univise Spinous Process Fixation Plate (35MM, 40MM)Stryker Spine · 2013
- Descendant · cites it directly · 9 of its ownK140046 Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015
- Descendant · 2 generations on · 8 of its ownK151741 HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015
- Descendant · 3 generations on · 7 of its ownK163428 HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017
- Descendant · 2 generations on · 6 of its ownK200066 Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020
- Descendant · 2 generations on · 5 of its ownK212781 Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS…Spinal Simplicity, LLC · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K140046Spinous Process Fusion (SPF) PlateSpinal Simplicity, LLC · 2015 · cites it directly9descendants
- K151741HA Minuteman G3 MIS Fusion PlateSpinal Simplicity, LLC · 2015 · 2 generations on8descendants
- K163428HA Minuteman G3-R MIS Fusion PlateSpinal Simplicity · 2017 · 3 generations on7descendants
- K200066Posterior Fusion Plate, HA Posterior Fusion PlateSpinal Simplicity, LLC · 2020 · 2 generations on6descendants
- K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…Spinal Simplicity, LLC · 2021 · 2 generations on5descendants
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 | K122509 | Vertiflex Spinous Process Fixation Plate | Vertiflex, Inc. | 2012 | — |
| 0 (this device) | K132968 | Univise Spinous Process Fixation Plate (35MM, 40MM) | Stryker Spine | 2013 | — |
| +1 | K140046 | Spinous Process Fusion (SPF) Plate | Spinal Simplicity, LLC | 2015 | — |
| +2 | K151741 | HA Minuteman G3 MIS Fusion Plate | Spinal Simplicity, LLC | 2015 | — |
| +3 | K163428 | HA Minuteman G3-R MIS Fusion Plate | Spinal Simplicity | 2017 | — |
| +2 | K200066 | Posterior Fusion Plate, HA Posterior Fusion Plate | Spinal Simplicity, LLC | 2020 | — |
| +2 | K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion… | Spinal Simplicity, LLC | 2021 | — |
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 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K131238 | Affix Spinous Process Plate SystemSummary page 1…substantially equivalent to the devices listed below: * Affix® Spinous Process Plate System, NuVasive Incorporated, K13 1238 * VertiFlex® Spinous Fixation Plate, VertiFlex Incorporated, K 122509 Device De… | 2013 |
| * | K122509 | Vertiflex Spinous Process Fixation PlateSummary page 1…NuVasive Incorporated, K13 1238 * VertiFlex® Spinous Fixation Plate, VertiFlex Incorporated, K 122509 Device Description The UniViseTM S pinous Process Fixation Plate is a one-piece bilateral locking plat… | 2012 |
What descends from it? (12)
See all 122 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 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K140046 (Spinal Simplicity, LLC, 2015) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K131238.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 UniViseTM Spinous Process Fixation 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: 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 UniViSeTM Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132968 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132968: Univise Spinous Process Fixation Plate (35MM, 40MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132968
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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