510(k) · Cleared
ClearedII-Type Intervertebral Spacer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paonan Biotech Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 11, 2019 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 2 other predicates after a 350-day review. Its family tree reaches back 11 generations to 1984. 1 of the 42 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jan 11, 2019
- Review
- 350 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K841189 (1984). 40 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 42 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK103111 Forza Spacer SystemOrthofix, Inc. · 2011 · Recalled
- This deviceK180228 II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK233075 “BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK103111 Forza Spacer SystemOrthofix, Inc. · 2011 · Recalled
- This deviceK180228 II-Type Intervertebral SpacerPaonan Biotech Co., Ltd. · 2019
Class I recalls in this family
- K073202 Ardis Spacer2 generations back · 2008
Most influential descendants
Showing 1 of 1 · See all- K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −1 | K103111 | Forza Spacer System | Orthofix, Inc. | 2011 | 1 |
| 0 (this device) | K180228 | II-Type Intervertebral Spacer | Paonan Biotech Co., Ltd. | 2019 | — |
| +1 | K233075 | “BioGend” Interbody Fusion System 001 Cage | Biogend Therapeutics Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 4…oduct Code: MAX Predicate Devices: Primary predicate device: Lumbar I/F Cage (P960025) Additional predicates: Capstone Spinal System (K073291)… | 1999 |
| * | K073291 | Capstone Spinal SystemSummary page 4…/F Cage (P960025) Additional predicates: Capstone Spinal System (K073291) FORZA Spacer System (K103111) Device Description: II-Type Intervertebral Spacer consists of… | 2008 |
| * | K103111 | Forza Spacer SystemSummary page 4…Additional predicates: Capstone Spinal System (K073291) FORZA Spacer System (K103111) Device Description: II-Type Intervertebral Spacer consists of PEEK cages of various widths and heights, which include Ta marke… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233075 | “BioGend” Interbody Fusion System 001 Cage | 2024 | 0 |
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 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 9 of the 40 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233075 (Biogend Therapeutics Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 98 other devices also cite its predicate P960025.
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. 2019, 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 II-Type Intervertebral Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These…
Read the full statement (136 words)
The II-Type Intervertebral Spacer is indicated for intervertebral body fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. This device is to be used with autograft
bone and/or allograft bone comprised of cancellous and/or corticocancellous bone graft. DDD is defined as discogenic
back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also
have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of
non-operative treatment prior to treatment with an intervertebral cage. The II-Type Intervertebral Spacer is to be
implanted via a direct posterior approach. These devices are intended to be used with supplemental fixation
instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180228: II-Type Intervertebral Spacer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180228
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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