510(k) Report

510(k) · Cleared

Cleared

AnyPlus® Cervical PEEK Cage System

K153517510(k) TraditionalCleared Jun 24, 2016199-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GS Medical Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical

Cleared on Jun 24, 2016 as substantially equivalent to K082801 (Us Spine, 2008) and 1 other predicate after a 199-day review. Its family tree reaches back 11 generations to 1984. 12 later devices descend from it.

Decided
Jun 24, 2016
Review
199 days
Class
Class II
Product code
ODP
Recalls
None
Predicates
2

Its longest line of descent runs back 11 generations to K841189 (1984). 32 ancestors in all. 12 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 2 other ancestors2002: 4 other ancestors2001: 4 other ancestors1999: 1 other ancestor1996: 1 other ancestor2005: 1 other ancestor2004: 4 other ancestors2003: 2 other ancestors2000: 1 other ancestor2023: 5 descendants cleared2024: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K080401 · Shell Cage, Wave Cage, Loop Cage · Advanced Medical Technologies AG · 2008K082801 · Phantom Plus Cage System · Us Spine · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors5 generations back: 2 other ancestors6 generations back: 4 other ancestors7 generations back: 5 other ancestors8 generations back: 2 other ancestors9 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K082801 · Phantom Plus Cage System · Us Spine · 2008K080401 · Shell Cage, Wave Cage, Loop Cage · Advanced Medical Technologies AG · 2008K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 7 generations between
  3. 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  4. 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
  5. 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
  6. This deviceK153517 AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd. · 2016
  7. Descendant · cites it directly · 6 of its ownK200592 GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd. · 2020
  8. Descendant · 2 generations on · 5 of its ownK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
  9. Descendant · 3 generations on · 4 of its ownK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
  10. Descendant · 4 generations on · 3 of its ownK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
  11. Descendant · 5 generations on · 2 of its ownK232822 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
Show all 11 generations
  1. Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 2 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
  11. 1 generation backK082801 Phantom Plus Cage SystemUs Spine · 2008
  12. This deviceK153517 AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd. · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2020: 12021: 12022: 12023: 52024: 12025: 12026: 2
2020high 5 (2023) · low 1 (2020)2026

Most influential descendants

Showing 5 of 12 · See all
  • K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd. · 2020 · cites it directly6descendants
  • K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021 · 2 generations on5descendants
  • K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022 · 3 generations on4descendants
  • K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 4 generations on3descendants
  • K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−10K990148Stackable Cage SystemDepuy Motech Acromed1999—
−9K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−8K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−7K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−6K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−5K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−4K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−3K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−2K080401Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG2008—
−1K082801Phantom Plus Cage SystemUs Spine2008—
0 (this device)K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.2016—
+1K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.2020—
+2K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.2021—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.2022—
+4K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)…Gbs Commonwealth Co., Ltd.2023—
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)…Gbs Commonwealth Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200010
200140
200240
200320
200440
200510
200820
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202210
202350
202410
202510
202620
FIG. 1 — Lineage of K153517, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K082801Phantom Plus Cage System
Summary page 4
…e System is based on its similarities in indications for use, design features, operational principles and material composition when compared to the predicate devices. * K082801 US Spine Phantom Cervical Cage (primary) e K091873 SpineArt Tryptik Cervical Cage (secondary) The subject device is substantiall…
Us Spine2008—
*K091873Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-S
Summary page 4
…s for use, design features, operational principles and material composition when compared to the predicate devices. * K082801 US Spine Phantom Cervical Cage (primary) e K091873 SpineArt Tryptik Cervical Cage (secondary) The subject device is substantially equivalent to similar previously cleared devices.…
Spineart2009—

Also cleared against K082801: 12 other devices →

What descends from it? (12)

See all 12

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200592GS Medical AnyPlus PEEK Cage SystemGS Medical Co., Ltd.20206
K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261
K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241
K222041CYGNUS-C Standalone ACIF SystemGS Medical Co., Ltd.20231

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 32 years and passes through 10 companies; a new generation was cleared every 1.0 years on median.
  • 2 of the 32 ancestors have a recall of any class.
  • Of its descendants, K200592 (GS Medical Co., Ltd., 2020) has gone furthest, with 6 descendants of its own.
  • 12 other devices also cite its predicate K082801.

How does its category compare?

All ODP devices

ODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · ODP

11in 2025

2008: 82009: 122010: 92011: 252012: 172013: 182014: 262015: 242016: 172017: 332018: 252019: 222020: 142021: 182022: 122023: 342024: 102025: 112026 (partial year): 19
2007high 34 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ODP

87in 2025

2008: 89 days median2009: 127 days median2010: 151 days median2011: 113 days median2012: 93 days median2013: 187 days median2014: 118 days median2015: 180 days median2016: 112 days median2017: 104 days median2018: 133 days median2019: 92 days median2020: 89 days median2021: 121 days median2022: 92 days median2023: 165 days median2024: 76 days median2025: 87 days median2026 (partial year): 117 days median
2007high 187 (2013) · low 76 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ODP

2in 2025

2009: 12011: 12013: 12020: 12025: 2
2007high 2 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ODP

57in 2025

2008: 22009: 212010: 542011: 382012: 922013: 782014: 432015: 512016: 372017: 392018: 512019: 1412020: 862021: 1612022: 502023: 362024: 552025: 57
2007high 161 (2021) · low 0 (2007)2025

MAUDE reports naming product code ODP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200888902
200912127121
20109151054
201125113138
20121793092
201318187178
201426118043
201524180051
201617112037
201733104039
201825133051
201922920141
20201489186
2021181210161
20221292050
202334165036
20241076055
20251187257
2026191170—

What is it indicated for?

The AnyPlus® Cervical PEEK Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K153517: AnyPlus® Cervical PEEK Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153517

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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