510(k) · Cleared
ClearedSP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · PEK Spinous Process Plate
Cleared on Mar 7, 2018 as substantially equivalent to K102195 (Globus Medical, Inc., 2011) and 4 other predicates after a 47-day review. Its family tree reaches back 9 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 7, 2018
- Review
- 47 days
- Class
- Class II
- Product code
- PEK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K000319 (2000). 115 ancestors in all, the oldest K761228 (1976). 5 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations between
- 3 generations backK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- 2 generations backK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- 1 generation backK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- This deviceK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- Descendant · cites it directly · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 8 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 7 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 6 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 5 generations backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- 4 generations backK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- 3 generations backK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- 2 generations backK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- 1 generation backK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- This deviceK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · cites it directly4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 3 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −8 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −7 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −6 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −5 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| −4 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| −3 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| −2 | K140678 | Cosmolock Pedicle Screw System | Kalitec Direct, LLC | 2014 | — |
| −1 | K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017 | — |
| 0 (this device) | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| +1 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +3 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +2 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
| +3 | K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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? (5)
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 |
|---|---|---|---|
| * | K102195 | SP-Fix Spinous Process Fixation PlateSummary page 5…PEK: SP-FIX® NQW: RELIEVE® Regulatory Class: II, Panel Code: 87 Primary SP-Fix® Spinous Process Fixation Plate (K102195, K132191) Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Predicates: HAVEN® Laminoplasty System (K1… | 2011 |
| * | K132191 | SP-Fix Spinous Process Fixation PlateSummary page 5…SP-FIX® NQW: RELIEVE® Regulatory Class: II, Panel Code: 87 Primary SP-Fix® Spinous Process Fixation Plate (K102195, K132191) Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Predicates: HAVEN® Laminoplasty System (K171413)… | 2013 |
| * | K080664 | Relieve Laminoplasty Fixation SystemSummary page 5…atory Class: II, Panel Code: 87 Primary SP-Fix® Spinous Process Fixation Plate (K102195, K132191) Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Predicates: HAVEN® Laminoplasty System (K171413) Kalitec Direct InSePtion MIS Fixation System (K163… | 2008 |
| * | K171413 | HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation SystemSummary page 5…x® Spinous Process Fixation Plate (K102195, K132191) Predicates: RELIEVE® Laminoplasty Fixation System (K080664) Predicates: HAVEN® Laminoplasty System (K171413) Kalitec Direct InSePtion MIS Fixation System (K163471) Reference Device: Anterior Spinal Devices PEEK (K152… | 2017 |
| * | K163471 | Kalitec Direct InSePtion™ MIS Fixation SystemSummary page 5…LIEVE® Laminoplasty Fixation System (K080664) Predicates: HAVEN® Laminoplasty System (K171413) Kalitec Direct InSePtion MIS Fixation System (K163471) Reference Device: Anterior Spinal Devices PEEK (K152022) Purpose: The purpose of this submission is to request clearance for a… | 2017 |
| † | K152022 | SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®… | 2017 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP… | 2018 | 4 |
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 18 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 115 ancestors have a recall of any class.
- Of its descendants, K181846 (Globus Medical, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K102195.
How does its category compare?
All PEK devicesPEK Spinous Process Plate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 SP-Fix® 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 the 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…
Read the full statement (147 words)
The SP-Fix® 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 the 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 SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use.
The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the allograft or autograft bone in place in order to prevent the graft from expulsion, or impinging the spinal cord.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180156: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180156
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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