510(k) · Cleared
Cleared4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solco Biomedical Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Sep 18, 2019 as substantially equivalent to K092162 (Solco Biomedical Co., Ltd., 2010) and 2 other predicates after a 197-day review. Its family tree reaches back 2 generations to 1996. 1 of the 7 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Sep 18, 2019
- Review
- 197 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P950002 (1996). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK073202 Ardis SpacerAbbott Spine, Inc. · 2008 · Recalled (Class I)
- This deviceK190563 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey…Solco Biomedical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK243973 FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation · 2025
- Descendant · cites it directly · 0 of its ownK213653 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited · 2022
Class I recalls in this family
- K073202 Ardis Spacerdirect predicate · 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 |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K073202 | Ardis Spacer | Abbott Spine, Inc. | 2008 | Class I |
| 0 (this device) | K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK… | Solco Biomedical Co., Ltd. | 2019 | — |
| +1 | K243973 | FIX-L PEEK PLIF and T-PLIF System | Jeil Medical Corporation | 2025 | — |
| +1 | K213653 | 4CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage System | Solco Biomedical Company India Private Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K092162 | 4CIS Peek, Plif and Tlif Cage SystemSummary page 4…Classification Code MAX Regulatory Class Class II Regulation Number 888.3080 4CIS® PEEK PLIF and TLIF Cage System (K092162, SE 01/06/2010) [Solco Biomedical Co., Ltd.] – Primary Predicate PATRIOTTM… | 2010 |
| * | K072970 | Patriot SpacersSummary page 4…dical Co., Ltd.] – Primary Predicate PATRIOTTM Spacers (ContinentalTM ALIF Spacer, Predicate Device TransContinentalTM LLIF Spacer) (K072970, SE 01/18/2008) [GLOBUS MEDICAL, INC.] – Additional Predicate ARDIS SPACER… | 2008 |
| * | K073202 | Ardis SpacerSummary page 4…ansContinentalTM LLIF Spacer) (K072970, SE 01/18/2008) [GLOBUS MEDICAL, INC.] – Additional Predicate ARDIS SPACER (K073202, SE 01/30/2008) [ABBOTT SPINE, INC.] – Additional Predicate… | 2008 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- 1 of the 4 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K243973 (Jeil Medical Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K092162.
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 Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with
Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous
levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and
radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and
are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of non-
operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190563: 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190563
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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