510(k) · Cleared
ClearedInnesis Peek TL 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 Oct 1, 2014 as substantially equivalent to K120464 (Bk Meditech, Co., Ltd., 2013) after a 209-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it.
- Decided
- Oct 1, 2014
- Review
- 209 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K003155 (2001). 28 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK120464 Innesis Peek CageBk Meditech, Co., Ltd. · 2013
- This deviceK140577 Innesis Peek TL CageBk Meditech, Co., Ltd. · 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
Show all 9 generations
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations backK012254 VBROsteotech, Inc. · 2001
- 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK120464 Innesis Peek CageBk Meditech, Co., Ltd. · 2013
- This deviceK140577 Innesis Peek TL CageBk Meditech, Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −8 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −7 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −4 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −3 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K120464 | Innesis Peek Cage | Bk Meditech, Co., Ltd. | 2013 | — |
| 0 (this device) | K140577 | Innesis Peek TL Cage | Bk Meditech, Co., Ltd. | 2014 | — |
| +1 | K172756 | Varian cage | Medyssey USA, Inc. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 2017 | 1 | 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? (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 |
|---|---|---|---|
| * | K120464 | Innesis Peek CageSummary page 5…he INNESIS PEEK TL Cages are substantially equivalent to the predicate devices listed below: 510(k) Tradename Manufacturer K120464-PRIMARY PREDICATE INNESIS PEEK CAGE BK MEDITECH Co, Ltd. K100089-Reference predicate SYNTHES T-PAL SPACER… | 2013 |
| † | K100089 | Synthes T-Pal Spacer | 2010 |
| † | K123388 | K7C Spacer | 2013 |
| † | K100042 | Difusion Technologies Xiphos Interbody Fusion System | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172756 | Varian cage | 2017 | 1 |
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 13 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K172756 (Medyssey USA, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K120464.
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 INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140577: Innesis Peek TL Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140577
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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