510(k) · Cleared
ClearedMedussa-PL Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey USA, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Dec 28, 2022 as substantially equivalent to K170341 (Medyssey USA, Inc., 2017) and 1 other predicate after a 22-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Dec 28, 2022
- Review
- 22 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010530 (2001). 14 ancestors in all, the oldest P950002 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 4 generations backK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
- 3 generations backK083894 Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC · 2011
- 2 generations backK112316 4-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · Recalled
- 1 generation backK170341 Medussa-PL CageMedyssey USA, Inc. · 2017
- This deviceK223654 Medussa-PL CageMedyssey USA, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −4 | K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | 2003 | — |
| −3 | K083894 | Alif Spinal Truss Interbody Fusion Device | 4-Web Spine, LLC | 2011 | — |
| −2 | K112316 | 4-Web Alif Spinal Truss System (STS) | 4-Web, Inc. | 2011 | 1 |
| −1 | K170341 | Medussa-PL Cage | Medyssey USA, Inc. | 2017 | — |
| 0 (this device) | K223654 | Medussa-PL Cage | Medyssey USA, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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.
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K170341 | Medussa-PL CageSummary page 5…K223654- Page 2 of 2 Predicate Device: The primary predicate device is the Medussa-PL Cage (K170341). The additional predicate device is the LP Cage (K110067). Substantial Equivalence Conclusion: The subject Medussa-PL Cage is s… | 2017 |
| * | K110067 | LP CageSummary page 5…K223654- Page 2 of 2 Predicate Device: The primary predicate device is the Medussa-PL Cage (K170341). The additional predicate device is the LP Cage (K110067). Substantial Equivalence Conclusion: The subject Medussa-PL Cage is substantially equivalent to the primary predicate, the Medu… | 2011 |
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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 5.2 years on median.
- 2 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K170341.
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. 2022, 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 Medussa-PL Cage is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
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/K223654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223654: Medussa-PL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223654
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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