510(k) · Cleared
ClearedInnesis Peek Cervical Cage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Meditech, Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Apr 2, 2014 as substantially equivalent to K120464 (Bk Meditech, Co., Ltd., 2013) and 8 other predicates after a 237-day review. Its family tree reaches back 14 generations to 2001. 1 of the 125 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 2, 2014
- Review
- 237 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 14 generations to K003155 (2001). 124 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet. 1 of the 125 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK112862 Mecta-CMedacta International · 2011
- This deviceK132483 Innesis Peek Cervical CageBk Meditech, Co., Ltd. · 2014
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 8 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 7 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 6 generations backK051205 Stryker Spine Avs Asl Peek SpacerStryker Spine · 2005
- 5 generations backK060762 Aesculap Peek Vertebral Body Replacement SystemAesculap, Inc. · 2006
- 4 generations backK071983 Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace…Aesculap Implant Systems, Inc. · 2008 · Recalled
- 3 generations backK083311 Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc. · 2009
- 2 generations backK100889 Endoskeleton TCTitan Spine, LLC · 2010
- 1 generation backK112862 Mecta-CMedacta International · 2011
- This deviceK132483 Innesis Peek Cervical CageBk Meditech, Co., Ltd. · 2014
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −8 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −7 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −6 | K051205 | Stryker Spine Avs Asl Peek Spacer | Stryker Spine | 2005 | — |
| −5 | K060762 | Aesculap Peek Vertebral Body Replacement System | Aesculap, Inc. | 2006 | — |
| −4 | K071983 | Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace… | Aesculap Implant Systems, Inc. | 2008 | 1 |
| −3 | K083311 | Aesculap Cespace Peek Intervertebral Body Fusion System | Aesculap Implant Systems, Inc. | 2009 | — |
| −2 | K100889 | Endoskeleton TC | Titan Spine, LLC | 2010 | — |
| −1 | K112862 | Mecta-C | Medacta International | 2011 | — |
| 0 (this device) | K132483 | Innesis Peek Cervical Cage | Bk Meditech, Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 13 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 1 |
| 2009 | 16 | 0 |
| 2010 | 6 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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.
1 device in this family has a Class I recall. 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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 2…Nurnber BK MEDITECH Co., Ltd INNESIS PEEK CAGE(lumbar) K120464 Stryker Spine Stryker Spine AVSO AS PEEK Spacer Ki120486 Southern Spine, LLC Sou… | 2013 |
| * | K120486 | Avs as Peek SpacerSummary page 2…ECH Co., Ltd INNESIS PEEK CAGE(lumbar) K120464 Stryker Spine Stryker Spine AVSO AS PEEK Spacer Ki120486 Southern Spine, LLC Southern Spine C-Fuse TM Cervical K130948 Inte… | 2012 |
| * | K130948 | C-Fuse Cervical Intervertebral Body Fusion System Cleared while this submission was under review Summary page 2…Spine Stryker Spine AVSO AS PEEK Spacer Ki120486 Southern Spine, LLC Southern Spine C-Fuse TM Cervical K130948 Intervertebral Body Fusion System SpineCraft, LLC ORIO Intervertebral Body F… | 2013 |
| * | K090887 | Orio-C Cervical, Orio-TL Tlif, Orio-PL Plif, Orio-AL Alif Intervedrtebral Body Fusion…Summary page 2…K130948 Intervertebral Body Fusion System SpineCraft, LLC ORIO Intervertebral Body Fusion Cage by K090887 Medacta International, SA Mecta-C K112862 Custom Spine… | 2009 |
| * | K112862 | Mecta-CSummary page 2…raft, LLC ORIO Intervertebral Body Fusion Cage by K090887 Medacta International, SA Mecta-C K112862 Custom Spine PATHWAY ACIF K092904 Biomet Spine… | 2011 |
| * | K092904 | Pathway Ivb/VBRSummary page 2…a International, SA Mecta-C K112862 Custom Spine PATHWAY ACIF K092904 Biomet Spine C-Thrum Anterior Spinal System K092336 BM Korea… | 2009 |
| * | K092336 | C-Thru Spinal SystemSummary page 2…Spine PATHWAY ACIF K092904 Biomet Spine C-Thrum Anterior Spinal System K092336 BM Korea SYNSTER® CERVICAL CAGE Kill1820 Medicrea Technologies… | 2009 |
| * | K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif Cage | 2012 |
| * | K072226 | Impix SpacerSummary page 2…a SYNSTER® CERVICAL CAGE Kill1820 Medicrea Technologies IMPIX cervical interbody device K072226 SUMMARY of TESTING: Testing results are for the following: - Static and dynamic axial compression test, conducted in accordance… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 16 of the 124 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K120464.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T 1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132483: Innesis Peek Cervical Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132483
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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