510(k) · Cleared
ClearedCOMET Lumbar Interbody Fusion Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baui Biotech Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 14, 2020 as substantially equivalent to K100089 (Synthes Spine, 2010) after a 329-day review. Its family tree reaches back 1 generation to 2010.
- Decided
- Apr 14, 2020
- Review
- 329 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K100089 (2010). No later device cites it as a predicate yet.
- Root · 1 generation backK100089 Synthes T-Pal SpacerSynthes Spine · 2010 · Recalled
- This deviceK191353 COMET Lumbar Interbody Fusion CageBaui Biotech Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K100089 | Synthes T-Pal Spacer | Synthes Spine | 2010 | 1 |
| 0 (this device) | K191353 | COMET Lumbar Interbody Fusion Cage | Baui Biotech Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K100089 | Synthes T-Pal SpacerSummary page 4…device. Classification: Class II per 21 CFR 888.3080 Product codes: MAX Predicate Device: SYNTHES T-PAL SPACER (K100089) Device Description: The COMET Lumbar Interbody Fusion Cage is a hollow, bullet-shaped PEEK cage (per ASTM F2026) with three Ta… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 17 other devices also cite its predicate K100089.
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. 2020, 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 COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous…
Read the full statement (131 words)
The COMET Lumbar Interbody Fusion Cage is indicated for use in intervertebral body fusion of the spine. The COMET Lumbar Interbody Fusion Cage is inserted via a transforaminal posterior lumbar fusion procedures in skeletally mature patients with degenerative disc disease (DDD defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) and intended for use with autogenous bone graft at one or two contiguous levels of the lumbosacral spine (L2-S1). The COMET Lumbar Interbody Fusion Cage is intended to be used with supplemental fixation systems cleared by the FDA for use in the lumbar spine. Patients should have at least six months of non-operative treatment prior to surgery. In addition, these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191353: COMET Lumbar Interbody Fusion Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191353
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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