510(k) · Cleared
ClearedGS Medical Anyplus Peek Lumbar Cages (Alif and Dlif)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 17, 2011 as substantially equivalent to K100516 (GS Medical Co., Ltd., 2010) after a 157-day review. Its family tree reaches back 2 generations to 1999. 11 later devices descend from it.
- Decided
- Oct 17, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P960025 (1999). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP960025 Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle…Depuy Spine, Inc. · 1999
- 1 generation backK100516 Anyplus Peek CagesGS Medical Co., Ltd. · 2010
- This deviceK111354 GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif)GS Medical Co., Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK131612 Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif…GS Medical Co., Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK243074 Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK221719 ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK212980 Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK242771 Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K131612Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek CagesGS Medical Co., Ltd. · 2014 · cites it directly8descendants
- K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc. · 2025 · 2 generations on2descendants
- K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc. · 2022 · cites it directly2descendants
- K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on2descendants
- K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | Depuy Spine, Inc. | 1999 | — |
| −1 | K100516 | Anyplus Peek Cages | GS Medical Co., Ltd. | 2010 | — |
| 0 (this device) | K111354 | GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif) | GS Medical Co., Ltd. | 2011 | — |
| +1 | K131612 | Anyplus; Alif Peek Cages, Plif Peek Cages, T-Plif Peek Cages, Tlif Peek Cages | GS Medical Co., Ltd. | 2014 | — |
| +2 | K243074 | Spectrum Spine Lumbar Cage System | Spectrum Spine, Inc. | 2025 | — |
| +1 | K221719 | ABTross ALIF Expandable Cage System | Aegis Spine, Inc. | 2022 | — |
| +2 | K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +3 | K242771 | Tesera-k PL System and Tesera-k XL System | Kyocera Medical Technologies, Inc. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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? (1)
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 |
|---|---|---|---|
| * | K100516 | Anyplus Peek CagesSummary page 1…ition when compared to the predicate devices cleared under the following submissions: *K 100516 AnyPlus PEEK Lumbar Cage 6… | 2010 |
What descends from it? (11)
See all 113 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 12 years and passes through 2 companies; a new generation was cleared every 11.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131612 (GS Medical Co., Ltd., 2014) has gone furthest, with 8 descendants of its own.
- 11 other devices also cite its predicate K100516.
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. 2011, 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?
AnyPlus® PEEK Lumbar Fusion Cage device is intended 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 1 spondylolisthesis or retrolisthesis at the involved level(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111354: GS Medical Anyplus Peek Lumbar Cages (Alif and Dlif).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111354
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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