510(k) · Cleared
ClearedPeridot Spinal Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gbs Commonwealth Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Mar 15, 2022 as substantially equivalent to K192026 (Gbs Commonwealth Co., Ltd., 2019) and 2 other predicates after an 85-day review. Its family tree reaches back 21 generations to 1984. 4 later devices descend from it.
- Decided
- Mar 15, 2022
- Review
- 85 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K841189 (1984). 345 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
- 1 generation backK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
- This deviceK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK233839 Peridot-PT Anterior Cervical Intervertebral body fusion System…Gbs Commonwealth Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK243915 FIX-C 3D Ti ACIF SystemJeil Medical Corporation · 2025
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 11 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 10 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 9 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 8 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 7 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 6 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 5 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 4 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 2 generations backK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
- 1 generation backK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
- This deviceK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd. · 2023 · cites it directly3descendants
- K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 2 generations on2descendants
- K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd. · 2023 · 3 generations on1descendant
- K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −11 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −10 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −9 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −8 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −7 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −6 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −5 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −4 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −2 | K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019 | — |
| −1 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021 | — |
| 0 (this device) | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | — |
| +1 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +2 | K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +3 | K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT… | Gbs Commonwealth Co., Ltd. | 2023 | — |
| +4 | K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025 | — |
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 | 41 | 0 |
| 2009 | 27 | 0 |
| 2010 | 21 | 0 |
| 2011 | 23 | 0 |
| 2012 | 12 | 0 |
| 2013 | 15 | 0 |
| 2014 | 14 | 0 |
| 2015 | 12 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K192026 | Peridot Intervertebral body fusion SystemSummary page 4…ct Introduction of the Peridot Spinal Interbody System. The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K192026 and K202872). The Peridot Spinal Interbody System has the same intended use and fundamental scientific technology as the… | 2019 |
| * | K202872 | Prase PEEK Anterior Cervical Interbody SpacerSummary page 4…ntroduction of the Peridot Spinal Interbody System. The Purpose of this 510(k) submission is to combine the existing 510(k) clearance system (K192026 and K202872). The Peridot Spinal Interbody System has the same intended use and fundamental scientific technology as the previously c… | 2021 |
| * | K163491 | NuVasive CoRoent Small Interbody SystemSummary page 5…Page 2 of 4 - Additional Predicate Device : K202872 Prase PEEK Anterior Cervical Interbody Spacer K163491 NuVasive CoRoent Small Interbody System 4. Description of the Device Peridot Spinal Interbody System This product i… | 2017 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior… | 2023 | 3 |
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 38 years and passes through 13 companies; a new generation was cleared every 1.0 years on median.
- 34 of the 345 ancestors have a recall of any class.
- Of its descendants, K230708 (Gbs Commonwealth Co., Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K192026.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment. The Peridot…
Read the full statement (206 words)
The Peridot Cervical Spinal Interbody System are intended for intervertebral body fusion devices in skeletally mature patients for the treatment of cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain at one or more contiguous levels from C2-T1. These patients should have had at least six weeks of nonoperative treatment.
The Peridot Cervical Spinal Interbody system are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to faciliate fusion and in combination with supplemental fixation indicated for cervical fusion procedures.
The Peridot Lumbar Spinal Interbody system are 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. The Peridot Lumbar Spinal Interbody system are 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/K213980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213980: Peridot Spinal Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213980
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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