510(k) · Cleared
ClearedLP Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medyssey Co, Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 8, 2011 as substantially equivalent to K072226 (Medicrea Technologies, 2007) after an 88-day review. Its family tree reaches back 2 generations to 1996. 15 later devices descend from it.
- Decided
- Apr 8, 2011
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P950002 (1996). 5 ancestors in all. 15 later devices descend from it, 5 citing it directly.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK072226 Impix SpacerMedicrea Technologies · 2007
- This deviceK110067 LP CageMedyssey Co, Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK120464 Innesis Peek CageBk Meditech, Co., Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK170341 Medussa-PL CageMedyssey USA, Inc. · 2017
- Descendant · cites it directly · 3 of its ownK140564 BN Lumbar Cage SystemMedyssey USA, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK140577 Innesis Peek TL CageBk Meditech, Co., Ltd. · 2014
- Descendant · cites it directly · 2 of its ownK121246 Medyssy LT Cage SystemMedyssey Co, Ltd. · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K120464Innesis Peek CageBk Meditech, Co., Ltd. · 2013 · cites it directly6descendants
- K170341Medussa-PL CageMedyssey USA, Inc. · 2017 · cites it directly4descendants
- K140564BN Lumbar Cage SystemMedyssey USA, Inc. · 2014 · cites it directly3descendants
- K140577Innesis Peek TL CageBk Meditech, Co., Ltd. · 2014 · 2 generations on2descendants
- K121246Medyssy LT Cage SystemMedyssey Co, Ltd. · 2012 · cites it directly2descendants
View 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 | K072226 | Impix Spacer | Medicrea Technologies | 2007 | — |
| 0 (this device) | K110067 | LP Cage | Medyssey Co, Ltd. | 2011 | — |
| +1 | K120464 | Innesis Peek Cage | Bk Meditech, Co., Ltd. | 2013 | — |
| +1 | K170341 | Medussa-PL Cage | Medyssey USA, Inc. | 2017 | — |
| +1 | K140564 | BN Lumbar Cage System | Medyssey USA, Inc. | 2014 | — |
| +2 | K140577 | Innesis Peek TL Cage | Bk Meditech, Co., Ltd. | 2014 | — |
| +1 | K121246 | Medyssy LT Cage System | Medyssey Co, Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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? (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 |
|---|---|---|---|
| * | K072226 | Impix SpacerSummary page 1…redicate Devices The LP Cage was shown to be substantially equivalentto legally marketed predicate devices. The predicate device for the Medyssey LIP Cage isthe IMPIX L (K072226). Indications for Use The LIP Cage® is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at… | 2007 |
What descends from it? (15)
See all 155 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 15 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120464 (Bk Meditech, Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.
- 10 other devices also cite its predicate K072226.
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. 2011, 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 LP 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 as stated in the FDA summary.
https://510kreport.com/device/K110067 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110067: LP Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110067
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