510(k) · Cleared
ClearedPeridot 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 26, 2019 as substantially equivalent to K151140 (L&K BIOMED Co., Ltd., 2015) and 6 other predicates after a 120-day review. Its family tree reaches back 19 generations to 1984. 6 later devices descend from it.
- Decided
- Nov 26, 2019
- Review
- 120 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 19 generations to K841189 (1984). 321 ancestors in all, the oldest K792352 (1979). 6 later devices descend from it, 2 citing it directly.
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 15 generations between
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
- Descendant · cites it directly · 5 of its ownK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System…Gbs Commonwealth Co., Ltd. · 2023
Show all 19 generations
- Root · 19 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 17 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 16 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 13 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 12 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 9 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 8 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 7 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 6 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 5 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 4 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 3 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 2 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 1 generation backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- This deviceK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021 · cites it directly5descendants
- K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022 · cites it directly4descendants
- K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 2 generations on3descendants
- K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 3 generations on2descendants
- K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −18 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −17 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −16 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −13 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −12 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −9 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −8 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −7 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −6 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −5 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −4 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −3 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −2 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −1 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| 0 (this device) | K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +1 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021 | — |
| +1 | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | — |
| +2 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +3 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +4 | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT… | 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 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 11 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 38 | 0 |
| 2005 | 24 | 0 |
| 2006 | 14 | 0 |
| 2007 | 16 | 0 |
| 2008 | 38 | 0 |
| 2009 | 23 | 0 |
| 2010 | 21 | 0 |
| 2011 | 21 | 0 |
| 2012 | 11 | 0 |
| 2013 | 13 | 0 |
| 2014 | 10 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 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 MAX? 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 |
|---|---|---|---|
| * | K151140 | LnK Lumbar Interbody Fusion Cage SystemSummary page 4…Introduction of Peridot Intervertebral fusion system. 3. Predicate or legally marketed devices which are substantially equivalent 1) Primary Predicate Device: K151140 LnK Lumbar Interbody Fusion Cage System 2) Additional Predicate device: K092193 Shurfit Interbody device system… | 2015 |
| * | K092193 | Spinal Usa Interbody CagesSummary page 4…eted devices which are substantially equivalent 1) Primary Predicate Device: K151140 LnK Lumbar Interbody Fusion Cage System 2) Additional Predicate device: K092193 Shurfit Interbody device system K153783 SpaceVision OLIF… | 2009 |
| * | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSummary page 4…ce: K151140 LnK Lumbar Interbody Fusion Cage System 2) Additional Predicate device: K092193 Shurfit Interbody device system K153783 SpaceVision OLIF K110927 MectaLIF Oblique K161379 ELS… | 2016 |
| * | K110927 | MectalifSummary page 4…dditional Predicate device: K092193 Shurfit Interbody device system K153783 SpaceVision OLIF K110927 MectaLIF Oblique K161379 ELSA Spacers… | 2011 |
| * | K161379 | ELSA SpacersSummary page 4…stem K153783 SpaceVision OLIF K110927 MectaLIF Oblique K161379 ELSA Spacers K192026 - Page 2 of 3… | 2016 |
| * | K151214 | ALIF Interfixated SystemSummary page 5…K161379 ELSA Spacers K192026 - Page 2 of 3 K151214, K161230 NuVasive Lumbar Interbody Implants 4. Description of the Device The Peridot Intervertebral Body Fusion Syste… | 2015 |
| * | K161230 | NuVasive Lumbar Interbody ImplantsSummary page 5…79 ELSA Spacers K192026 - Page 2 of 3 K151214, K161230 NuVasive Lumbar Interbody Implants 4. Description of the Device The Peridot Intervertebral Body Fusion System is inte… | 2016 |
What descends from it? (6)
2 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 35 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 32 of the 321 ancestors have a recall of any class.
- Of its descendants, K202872 (Gbs Commonwealth Co., Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K151140.
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. 2019, 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?
Peridot 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. Peridot Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192026: Peridot 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/K192026
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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