510(k) · Cleared
ClearedPeek Cas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Cross Intl. · MQP Spinal Vertebral Body Replacement Device
Cleared on May 27, 2005 as substantially equivalent to K040928 (Interpore Cross Intl., 2004) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 2004. 224 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040168 (2004). 2 ancestors in all. 224 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK040168 Modification to Geo StructureInterpore Cross Intl. · 2004 · Recalled
- This deviceK050861 Peek CasInterpore Cross Intl. · 2005
- Descendant · cites it directly · 181 of its ownK091381 Ibex Spinal SystemEbi, L.P. · 2009
- Descendant · 2 generations on · 177 of its ownK110650 Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011
- Descendant · cites it directly · 174 of its ownK112014 Zyston Straight Spacer SystemBiomet Spine · 2011
- Descendant · 2 generations on · 171 of its ownK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · 3 generations on · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
Showing 5 of 224 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 224 · See all- K091381Ibex Spinal SystemEbi, L.P. · 2009 · cites it directly181descendants
- K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC) · 2011 · 2 generations on177descendants
- K112014Zyston Straight Spacer SystemBiomet Spine · 2011 · cites it directly174descendants
- K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 2 generations on171descendants
- K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040168 | Modification to Geo Structure | Interpore Cross Intl. | 2004 | 1 |
| 0 (this device) | K050861 | Peek Cas | Interpore Cross Intl. | 2005 | — |
| +1 | K091381 | Ibex Spinal System | Ebi, L.P. | 2009 | — |
| +2 | K110650 | Zyston Arc Interbody Spacer | Biomet Spine (Aka Ebi, LLC) | 2011 | — |
| +1 | K112014 | Zyston Straight Spacer System | Biomet Spine | 2011 | — |
| +2 | K122989 | Biomet Lateral Spacer System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +3 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 15 | 0 |
| 2021 | 16 | 0 |
| 2022 | 19 | 0 |
| 2023 | 31 | 0 |
| 2024 | 32 | 0 |
| 2025 | 33 | 0 |
| 2026 | 31 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 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 |
|---|---|---|---|
| * | K040928 | Expandable Peek VBR ImplantSummary page 1…Product Classification: Class 11 Product Code: MQP Proprietary Name: PEEK CAS PREDICATE DEVICE interpore Cross Expandable PEEK VBR (K040928) interpore Cross NEXUS (K040 168) INDICATIONS-FOR-USE The PEEK CAS is indicated for use in the thoracolurmbar spine (i.e., TI to… | 2004 |
| * | K040168 | Modification to Geo StructureSummary page 1…1 Product Code: MQP Proprietary Name: PEEK CAS PREDICATE DEVICE interpore Cross Expandable PEEK VBR (K040928) interpore Cross NEXUS (K040 168) INDICATIONS-FOR-USE The PEEK CAS is indicated for use in the thoracolurmbar spine (i.e., TI to L-5) for partial replacement of… | 2004 |
What descends from it? (224)
See all 2243 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?
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050861 · printed Nov 4, 2026
Cite this page
510(k) Report. “K050861: Peek Cas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K050861
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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