510(k) · Cleared
ClearedKalitec Direct InSePtion™ MIS Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kalitec Direct, LLC · PEK Spinous Process Plate
Cleared on Mar 16, 2017 as substantially equivalent to K133052 (Nuvasive, Inc., 2013) and 2 other predicates after a 94-day review. Its family tree reaches back 8 generations to 2000. 6 later devices descend from it.
- Decided
- Mar 16, 2017
- Review
- 94 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K000319 (2000). 95 ancestors in all, the oldest K781443 (1978). 6 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 7 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 6 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 5 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 4 generations backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- 3 generations backK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- 2 generations backK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- 1 generation backK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- This deviceK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- Descendant · cites it directly · 5 of its ownK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 4 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180156SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · 2 generations on4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 3 generations on2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 4 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −7 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −6 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −5 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −4 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| −3 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| −2 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| −1 | K140678 | Cosmolock Pedicle Screw System | Kalitec Direct, LLC | 2014 | — |
| 0 (this device) | K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017 | — |
| +1 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +2 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +3 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +4 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +3 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 8 | 0 |
| 2004 | 5 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K133052 | Affix (R) Next Gen Spinous Process Plate SystemSummary page 4…pinal interlaminal fixation orthosis Class: II Product Codes: PEK Primary Predicate Device: NuVasive Affix Spinous Process Plate System (K133052) Additional Predicates: Lanx Aspen Spinal Fixation System (K071877) Kalitec Direct CosmoLock Pedicl… | 2013 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 4…duct Codes: PEK Primary Predicate Device: NuVasive Affix Spinous Process Plate System (K133052) Additional Predicates: Lanx Aspen Spinal Fixation System (K071877) Kalitec Direct CosmoLock Pedicle Screw System (K140678) Indications For Use: The Kalitec Direct… | 2007 |
| * | K140678 | Cosmolock Pedicle Screw SystemSummary page 4…ss Plate System (K133052) Additional Predicates: Lanx Aspen Spinal Fixation System (K071877) Kalitec Direct CosmoLock Pedicle Screw System (K140678) Indications For Use: The Kalitec Direct InSePtion™ MIS Fixation System is a posterior, non-pedic… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | 2018 | 5 |
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 7 companies; a new generation was cleared every 2.3 years on median.
- 12 of the 95 ancestors have a recall of any class.
- Of its descendants, K180156 (Globus Medical, Inc., 2018) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K133052.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Kalitec Direct InSePtion™ MIS Fixation 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 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 Kalitec Direct InSePtion™ MIS Fixation System is not intended for standalone use, and is intended for use with autograft or allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163471 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163471: Kalitec Direct InSePtion™ MIS Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163471
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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