510(k) · Cleared
ClearedPYXIS 3D Titanium Cage System
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 Apr 26, 2023 as substantially equivalent to K172888 (Eit Emerging Implant Technologies GmbH, 2017) and 2 other predicates after a 124-day review. Its family tree reaches back 18 generations to 1984. 1 of the 177 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Apr 26, 2023
- Review
- 124 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 174 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 177 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 2 generations backK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- 1 generation backK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- This deviceK223868 PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241738 PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK243915 FIX-C 3D Ti ACIF SystemJeil Medical Corporation · 2025
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK051454 Aleutian Spacer SystemK2m, LLC · 2005
- 10 generations backK063399 Aleutian Spacer SystemK2m, Inc. · 2007
- 9 generations backK082698 Aleutian Ibf SystemK2m, Inc. · 2009
- 8 generations backK101302 Aleutian Ibf SystemK2m, Inc. · 2010
- 7 generations backK103169 AleuttianK2m, Inc. · 2011
- 6 generations backK130699 Aleutian Spinal SystemK2m, Inc. · 2013
- 5 generations backK133614 Aleutian Ibf SystemK2m, Inc. · 2014
- 4 generations backK143258 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc. · 2015
- 3 generations backK170503 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF…Eit Emerging Implant Technologies GmbH · 2017 · Recalled
- 2 generations backK172888 EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF…Eit Emerging Implant Technologies GmbH · 2017
- 1 generation backK181644 EIT Cellular Titanium® Lumbar Cage LLIFEit Emerging Implant Technologies GmbH · 2018
- This deviceK223868 PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd. · 2023
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K051454 | Aleutian Spacer System | K2m, LLC | 2005 | — |
| −10 | K063399 | Aleutian Spacer System | K2m, Inc. | 2007 | — |
| −9 | K082698 | Aleutian Ibf System | K2m, Inc. | 2009 | — |
| −8 | K101302 | Aleutian Ibf System | K2m, Inc. | 2010 | — |
| −7 | K103169 | Aleuttian | K2m, Inc. | 2011 | — |
| −6 | K130699 | Aleutian Spinal System | K2m, Inc. | 2013 | — |
| −5 | K133614 | Aleutian Ibf System | K2m, Inc. | 2014 | — |
| −4 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015 | — |
| −3 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | 2 |
| −2 | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT… | Eit Emerging Implant Technologies GmbH | 2017 | — |
| −1 | K181644 | EIT Cellular Titanium® Lumbar Cage LLIF | Eit Emerging Implant Technologies GmbH | 2018 | — |
| 0 (this device) | K223868 | PYXIS 3D Titanium Cage System | GS Medical Co., Ltd. | 2023 | — |
| +1 | K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | 2024 | — |
| +2 | K243915 | FIX-C 3D Ti ACIF System | Jeil Medical Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 2 | 0 |
| 2007 | 10 | 0 |
| 2008 | 25 | 1 |
| 2009 | 16 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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.
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 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? (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 |
|---|---|---|---|
| * | K172888 | EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular…Summary page 5…EIT Cellular Titanium Cervical Cages, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, EIT Cellular Titanium ALIF Cages K172888 MAX, ODP 21 CFR 888.3080 Class II Additional Predicates: • EIT Cel… | 2017 |
| * | K181644 | EIT Cellular Titanium® Lumbar Cage LLIFSummary page 5…MAX, ODP 21 CFR 888.3080 Class II Additional Predicates: • EIT Cellular Titanium Lumbar cage LLIF K181644 MAX 21 CFR 888.3080 Class II • AnyPlus PEEK Cage K100516… | 2018 |
| * | K100516 | Anyplus Peek CagesSummary page 5…lar Titanium Lumbar cage LLIF K181644 MAX 21 CFR 888.3080 Class II • AnyPlus PEEK Cage K100516 MAX 21 CFR 888.3080 Class II IV. INTENDED USE/INDICATIONS FOR USE: The PYXI… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241738 | PYXIS 3D Titanium Cervical Cage system | 2024 | 1 |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 20 of the 174 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K241738 (GS Medical Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K172888.
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. 2023, 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?
The PYXIS 3D Titanium Cage System 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-S 1. 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).
The PYXIS 3D Titanium Cage System is to be combined with supplemental fixation cleared for use in the lumbar spine.
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/K223868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223868: PYXIS 3D Titanium Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223868
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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