510(k) · Cleared
ClearedInnesis Peek Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Meditech, Co., Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 18, 2013 as substantially equivalent to K050624 (Stryker Spine, 2005) and 2 other predicates after a 338-day review. Its family tree reaches back 8 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 18, 2013
- Review
- 338 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K003155 (2001). 27 ancestors in all, the oldest K841189 (1984). 6 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 7 generations backK012254 VBROsteotech, Inc. · 2001
- 6 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 4 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 3 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 2 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 1 generation backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- This deviceK120464 Innesis Peek CageBk Meditech, Co., Ltd. · 2013
- Descendant · cites it directly · 2 of its ownK140577 Innesis Peek TL CageBk Meditech, Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK172756 Varian cageMedyssey USA, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK123607 Octane Elevate Spinal Implant SystemExactech, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK220953 ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK203327 VERTACONNECT TLIF CageSignus Medizintechnik · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K140577Innesis Peek TL CageBk Meditech, Co., Ltd. · 2014 · cites it directly2descendants
- K172756Varian cageMedyssey USA, Inc. · 2017 · 2 generations on1descendant
- K123607Octane Elevate Spinal Implant SystemExactech, Inc. · 2014 · cites it directly1descendant
- K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC · 2022 · 2 generations on0descendants
- K203327VERTACONNECT TLIF CageSignus Medizintechnik · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −7 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −6 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −4 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −3 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −2 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| 0 (this device) | K120464 | Innesis Peek Cage | Bk Meditech, Co., Ltd. | 2013 | — |
| +1 | K140577 | Innesis Peek TL Cage | Bk Meditech, Co., Ltd. | 2014 | — |
| +2 | K172756 | Varian cage | Medyssey USA, Inc. | 2017 | — |
| +1 | K123607 | Octane Elevate Spinal Implant System | Exactech, Inc. | 2014 | — |
| +2 | K220953 | ChoiceSpine TigerShark™ M, Modular Interbody System | Choice Spine, LLC | 2022 | — |
| +3 | K203327 | VERTACONNECT TLIF Cage | Signus Medizintechnik | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K050624 | Stryker Spine Avs PL Peek SpacerSummary page 1…atures, operational principles and material composition when compared to the predicate device cleared under the following submission: * K050624 - AVSTM PL PEEK Spacer, Stryker Spine Co., Ltd * K092 162 - 4C15 PEEK PLIF Cage System, Solco Biomedical Co.… | 2005 |
| * | K092162 | 4CIS Peek, Plif and Tlif Cage SystemSummary page 1…predicate device cleared under the following submission: * K050624 - AVSTM PL PEEK Spacer, Stryker Spine Co., Ltd * K092 162 - 4C15 PEEK PLIF Cage System, Solco Biomedical Co. Ltd * KI 10067 - LP Cage, Medyssey Co., Ltd 4.… | 2010 |
| * | K110067 | LP Cage | 2011 |
What descends from it? (6)
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 12 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K140577 (Bk Meditech, Co., Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K050624.
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. 2013, 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 INNESIS PEEK Cages wre indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-SI. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120464: Innesis Peek Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120464
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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