510(k) · Cleared
ClearedAnyplus Peek Cages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Dec 3, 2010 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 1 other predicate after a 283-day review. Its family tree reaches back 1 generation to 1999. 1 of the 639 devices in its family, counting itself, has a Class I recall. 636 later devices descend from it.
- Decided
- Dec 3, 2010
- Review
- 283 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P960025 (1999). 2 ancestors in all. 636 later devices descend from it, 12 citing it directly. 1 of the 639 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- This deviceK100516 Anyplus Peek CagesGS Medical Co., Ltd. · 2010
- Descendant · cites it directly · 595 of its ownK131082 Interform Interbody Cage SystemNext Orthosurgical · 2013
- Descendant · 2 generations on · 588 of its ownK141665 NuVasive CoRoent SystemNuvasive, Inc. · 2015
- Descendant · 3 generations on · 479 of its ownK151472 NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 402 of its ownK150994 NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015
- Descendant · 4 generations on · 400 of its ownK153419 NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016
Showing 5 of 636 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 636 · See all- K131082Interform Interbody Cage SystemNext Orthosurgical · 2013 · cites it directly595descendants
- K141665NuVasive CoRoent SystemNuvasive, Inc. · 2015 · 2 generations on588descendants
- K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated · 2015 · 3 generations on479descendants
- K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated · 2015 · 3 generations on402descendants
- K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated · 2016 · 4 generations on400descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| 0 (this device) | K100516 | Anyplus Peek Cages | GS Medical Co., Ltd. | 2010 | — |
| +1 | K131082 | Interform Interbody Cage System | Next Orthosurgical | 2013 | — |
| +2 | K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015 | — |
| +3 | K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015 | — |
| +4 | K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 9 | 0 |
| 2016 | 17 | 0 |
| 2017 | 37 | 0 |
| 2018 | 34 | 0 |
| 2019 | 47 | 0 |
| 2020 | 64 | 0 |
| 2021 | 54 | 1 |
| 2022 | 65 | 0 |
| 2023 | 77 | 0 |
| 2024 | 85 | 0 |
| 2025 | 75 | 0 |
| 2026 | 59 | 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…n indications for use, design features, operational principles and material composition when compared to the predicate devices cleared under the following submissions: s P960025 - Brantigen Interbody Fusion Cage, DePuy Spinc o K090887 - ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIJF Intervertebral Body Fusion C… | 1999 |
| * | K090887 | Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion…Summary page 1…iples and material composition when compared to the predicate devices cleared under the following submissions: s P960025 - Brantigen Interbody Fusion Cage, DePuy Spinc o K090887 - ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIJF Intervertebral Body Fusion Cage, SpineCrafi, LLC Fage |f2 Kico 516 R… | 2009 |
What descends from it? (636)
See all 63612 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131082 | Interform Interbody Cage System | 2013 | 595 |
| K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 | 38 |
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 | 20 |
| K111354 | GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif) | 2011 | 11 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K122518 | Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage… | 2013 | 3 |
| K223868 | PYXIS 3D Titanium Cage System | 2023 | 2 |
| K221719 | ABTross ALIF Expandable Cage System | 2022 | 2 |
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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100516: Anyplus Peek Cages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100516
Report an extraction error
Are you the manufacturer?
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