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 Nov 2, 2017 as substantially equivalent to K110067 (Medyssey Co, Ltd., 2011) and 1 other predicate after a 272-day review. Its family tree reaches back 5 generations to 2001. 4 later devices descend from it.
- Decided
- Nov 2, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010530 (2001). 13 ancestors in all, the oldest P950002 (1996). 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 4 generations backK020048 Modification to Geo StructureInterpore Cross Intl. · 2002
- 3 generations backK031672 Spinal Concepts, Inc. Infix SystemSpinal Concepts, Inc. · 2003
- 2 generations backK083894 Alif Spinal Truss Interbody Fusion Device4-Web Spine, LLC · 2011
- 1 generation backK112316 4-Web Alif Spinal Truss System (STS)4-Web, Inc. · 2011 · Recalled
- This deviceK170341 Medussa-PL CageMedyssey USA, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK180990 TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK223654 Medussa-PL CageMedyssey USA, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK200283 Medussa-PL CageMedyssey USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK181229 TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018 · cites it directly1descendant
- K223654Medussa-PL CageMedyssey USA, Inc. · 2022 · cites it directly0descendants
- K200283Medussa-PL CageMedyssey USA, Inc. · 2020 · cites it directly0descendants
- K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −4 | K020048 | Modification to Geo Structure | Interpore Cross Intl. | 2002 | — |
| −3 | K031672 | Spinal Concepts, Inc. Infix System | Spinal Concepts, Inc. | 2003 | — |
| −2 | K083894 | Alif Spinal Truss Interbody Fusion Device | 4-Web Spine, LLC | 2011 | — |
| −1 | K112316 | 4-Web Alif Spinal Truss System (STS) | 4-Web, Inc. | 2011 | 1 |
| 0 (this device) | K170341 | Medussa-PL Cage | Medyssey USA, Inc. | 2017 | — |
| +1 | K180990 | TirboLOX-L Lumbar IBFD | Captiva Spine, Inc. | 2018 | — |
| +1 | K223654 | Medussa-PL Cage | Medyssey USA, Inc. | 2022 | — |
| +1 | K200283 | Medussa-PL Cage | Medyssey USA, Inc. | 2020 | — |
| +2 | K181229 | TirboLOX-C Cervical IBFD | Captiva Spine, Inc. | 2018 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K110067 | LP CageSummary page 4…Regulation Number 21 CFR 888.3080 Product Code MAX Name of Predicate Device 510(k) # Manufacturer Medyssey LP Cage (Primary) K110067 Medyssey Co., Ltd 4-WEB ALIF SPINAL TRUSS K112316 4-WEB, INC. SYSTEM (STS) Description… | 2011 |
| * | K112316 | 4-Web Alif Spinal Truss System (STS)Summary page 4…f Predicate Device 510(k) # Manufacturer Medyssey LP Cage (Primary) K110067 Medyssey Co., Ltd 4-WEB ALIF SPINAL TRUSS K112316 4-WEB, INC. SYSTEM (STS) Description The Medussa-PL Cage is comprised of a variety of implant sizes and… | 2011 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K180990 (Captiva Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K110067.
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. 2017, 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 1 spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170341: 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/K170341
Report an extraction error
Are you the manufacturer?
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