510(k) · Cleared
ClearedPeridot-EX Expandable Intervertebral Body Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gbs Commonwealth Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 7, 2023 as substantially equivalent to K193258 (Life Spine, Inc., 2020) and 6 other predicates after a 98-day review. Its family tree reaches back 26 generations to 1984. 1 of the 629 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 7, 2023
- Review
- 98 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 26 generations to K841189 (1984). 628 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 629 devices in this family, counting this one, has a Class I recall.
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations between
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- 1 generation backK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- This deviceK232292 Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
Show all 26 generations
- Root · 26 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 25 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 24 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 23 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 20 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 19 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 16 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 15 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 14 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 13 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 12 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 11 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 10 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 9 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 6 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 5 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 2 generations backK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- 1 generation backK222554 EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical · 2023
- This deviceK232292 Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd. · 2023
Class I recalls in this family
- K073202 Ardis Spacer7 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −26 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −25 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −24 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −23 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −20 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −19 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −16 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −15 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −14 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −13 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −12 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −11 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −10 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −9 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −2 | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| −1 | K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023 | — |
| 0 (this device) | K232292 | Peridot-EX Expandable Intervertebral Body Fusion System | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 5 | 0 |
| 1998 | 8 | 0 |
| 1999 | 8 | 0 |
| 2000 | 18 | 0 |
| 2001 | 22 | 0 |
| 2002 | 19 | 0 |
| 2003 | 29 | 0 |
| 2004 | 46 | 0 |
| 2005 | 42 | 0 |
| 2006 | 30 | 0 |
| 2007 | 27 | 0 |
| 2008 | 63 | 1 |
| 2009 | 46 | 0 |
| 2010 | 33 | 0 |
| 2011 | 39 | 0 |
| 2012 | 30 | 0 |
| 2013 | 32 | 0 |
| 2014 | 27 | 0 |
| 2015 | 24 | 0 |
| 2016 | 16 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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.
1 device in this family has a Class I recall. 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K193258 | ProLift Expandable SystemSummary page 4…n of Peridot-EX Expandable Intervertebral body fusion system 3. Predicate or legally marketed devices which are substantially equivalent - Primary Predicate Device : K193258 ProLift Expandable System, Life Spine, Inc. - Additional Predicate Device : 1) K210800 IO Expandable Lumbar Interbody Fusion syst… | 2020 |
| * | K210800 | IO Expandable Lumbar Interbody Fusion SystemSummary page 4…y marketed devices which are substantially equivalent - Primary Predicate Device : K193258 ProLift Expandable System, Life Spine, Inc. - Additional Predicate Device : 1) K210800 IO Expandable Lumbar Interbody Fusion system, MiRus,LLC 2) K142498 Magnify and Magnify-S Spacers, Globus Me… | 2021 |
| * | K142498 | MAGNIFY and MAGNIFY-S SpacersSummary page 4…8 ProLift Expandable System, Life Spine, Inc. - Additional Predicate Device : 1) K210800 IO Expandable Lumbar Interbody Fusion system, MiRus,LLC 2) K142498 Magnify and Magnify-S Spacers, Globus Medical, Inc. 3) K222554 EL Capitan Anterior Lumbar Interbody Fusion,… | 2015 |
| * | K222554 | EL CAPITAN Anterior Lumbar Interbody FusionSummary page 4…0800 IO Expandable Lumbar Interbody Fusion system, MiRus,LLC 2) K142498 Magnify and Magnify-S Spacers, Globus Medical, Inc. 3) K222554 EL Capitan Anterior Lumbar Interbody Fusion, Astura Medical 4) K161379 ELSA Spacers, Globus Medical, Inc.… | 2023 |
| * | K161379 | ELSA SpacersSummary page 4…8 Magnify and Magnify-S Spacers, Globus Medical, Inc. 3) K222554 EL Capitan Anterior Lumbar Interbody Fusion, Astura Medical 4) K161379 ELSA Spacers, Globus Medical, Inc. 5) K213755 Peridot-PT Intervertebral fusion System, GBS Commonwealth… | 2016 |
| * | K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…Summary page 4…3) K222554 EL Capitan Anterior Lumbar Interbody Fusion, Astura Medical 4) K161379 ELSA Spacers, Globus Medical, Inc. 5) K213755 Peridot-PT Intervertebral fusion System, GBS Commonwealth K232292… | 2023 |
| * | K190762 | The JASPER Spinal Fixation System IISummary page 6…ivalent to the primary predicate device ProLift Expandable System K193258 and additional predicated devices K210800, K142498, K222554, K161379, K213755 and K190762. They are similar in design, material, scientific technologies and indications for use. 7. Performance Testing Th… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 7 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 16 companies; a new generation was cleared every 10 months on median.
- 62 of the 628 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K193258.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Peridot-EX Expandable Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).…
Read the full statement (172 words)
The Peridot-EX Expandable Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
This device is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems and anterior screw and rod systems).
The Peridot-EX Expandable Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.
Hyperlordotic interbody devices (> 20° lordosis) must be used with at least anterior supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232292: Peridot-EX Expandable Intervertebral Body Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232292
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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