510(k) · Cleared
ClearedBN Lumbar Cage System
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 Jun 5, 2014 as substantially equivalent to K110067 (Medyssey Co, Ltd., 2011) and 1 other predicate after a 92-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Jun 5, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P950002 (1996). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK072226 Impix SpacerMedicrea Technologies · 2007
- 1 generation backK110067 LP CageMedyssey Co, Ltd. · 2011
- This deviceK140564 BN Lumbar Cage SystemMedyssey USA, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK172756 Varian cageMedyssey USA, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK203327 VERTACONNECT TLIF CageSignus Medizintechnik · 2021
- Descendant · cites it directly · 0 of its ownK170389 TAURUS PEEK Cage SystemMedyssey USA, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| −1 | K110067 | LP Cage | Medyssey Co, Ltd. | 2011 | — |
| 0 (this device) | K140564 | BN Lumbar Cage System | Medyssey USA, Inc. | 2014 | — |
| +1 | K172756 | Varian cage | Medyssey USA, Inc. | 2017 | — |
| +2 | K203327 | VERTACONNECT TLIF Cage | Signus Medizintechnik | 2021 | — |
| +1 | K170389 | TAURUS PEEK Cage System | Medyssey USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2021 | 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 1…lassification Name: 87 MAX- Orthosis, intervertebral body fusion device, 21 CFR 888.3080, Class 11 Predicate Device: The predicate devices include the Medyssey LP Cage (K110067) and the Stryker AVS Spacer (K093704). Product Description: The Medyssey BN Cage is designed to provide mechanical support while… | 2011 |
| * | K093704 | Avs PL Peek SpacersSummary page 1…intervertebral body fusion device, 21 CFR 888.3080, Class 11 Predicate Device: The predicate devices include the Medyssey LP Cage (K110067) and the Stryker AVS Spacer (K093704). Product Description: The Medyssey BN Cage is designed to provide mechanical support while biologic fusion takes place. The sys… | 2009 |
What descends from it? (3)
2 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 18 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K172756 (Medyssey USA, Inc., 2017) 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. 2014, 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 BIN 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 bane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140564: BN Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140564
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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