510(k) · Cleared
ClearedZ-Clamp ISP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zavation, LLC · PEK Spinous Process Plate
Cleared on Oct 19, 2016 as substantially equivalent to K141508 (Spineart, 2014) after a 191-day review. Its family tree reaches back 8 generations to 1999.
- Decided
- Oct 19, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K990745 (1999). 33 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.
- 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 backK130438 Axle Interspinous Fusion SystemX-Spine Systems, Inc. · 2013 · Recalled
- 1 generation backK141508 Romeo 2 Pad Posterior Axial DeviceSpineart · 2014
- This deviceK161016 Z-Clamp ISP SystemZavation, LLC · 2016
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 | K130438 | Axle Interspinous Fusion System | X-Spine Systems, Inc. | 2013 | 1 |
| −1 | K141508 | Romeo 2 Pad Posterior Axial Device | Spineart | 2014 | — |
| 0 (this device) | K161016 | Z-Clamp ISP System | Zavation, LLC | 2016 | — |
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 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K141508 | Romeo 2 Pad Posterior Axial DeviceSummary page 4…ZĞŐƵůĂƚŽƌLJůĂƐƐ͗// WĂŶĞůŽĚĞ͗ϴϳ Primary Predicate: K141508 Spineart, Romeo 2Pad Device Description: The Zavation Z-CLAMP ISP System is a spinous process plate which is a temporary, titan… | 2014 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 4 of the 33 ancestors have a recall of any class.
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 Z-Clamp ISP System is a posterior, non-pedicle supplemental fixation device, intended for use as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous process for the purpose of achieving stabilization as an adjunction to 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, spondylolisthesis, trauma (i.e. fracture or dislocation) and/or tumor. The Z-Clamp ISP System is not intended for standalone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161016: Z-Clamp ISP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161016
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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