510(k) · Cleared
ClearedAnatomic Peek Cervical Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Sep 23, 2013 after a 241-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 628 later devices descend from it.
- Decided
- Sep 23, 2013
- Review
- 241 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
628 later devices descend from it, 10 citing it directly.
- This deviceK130177 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 532 of its ownK142264 Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014
- Descendant · cites it directly · 449 of its ownK142050 Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · cites it directly · 444 of its ownK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- Descendant · 2 generations on · 441 of its ownK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
Showing 5 of 628 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 628 · See all- K142264Valeo C Spacer System, Valeo II C IBF DeviceAmedica Corp. · 2014 · cites it directly532descendants
- K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated · 2014 · cites it directly449descendants
- K140921Coroent Small Interbody SystemNu Vasive, Incorporated · 2014 · cites it directly444descendants
- K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015 · 2 generations on441descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K130177 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K142264 | Valeo C Spacer System, Valeo II C IBF Device | Amedica Corp. | 2014 | — |
| +1 | K142050 | Nuvasive Coroent Small Contoured Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +1 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| +2 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 9 | 0 |
| 2015 | 13 | 0 |
| 2016 | 18 | 0 |
| 2017 | 49 | 0 |
| 2018 | 38 | 0 |
| 2019 | 50 | 0 |
| 2020 | 63 | 0 |
| 2021 | 53 | 0 |
| 2022 | 61 | 0 |
| 2023 | 79 | 0 |
| 2024 | 67 | 0 |
| 2025 | 67 | 0 |
| 2026 | 61 | 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 ODP? 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K111244 | FDA’s K111244 is Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Our reading of the summary gave K111244, FDA’s number for Turbo-Ject Peripherally Inserted Central Venous Catheter… (Cook, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ANATOMIC PEEK CERVICAL FUSION SYSTEM”. Kept off the family tree. | 2011 |
What descends from it? (628)
See all 62810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142264 | Valeo C Spacer System, Valeo II C IBF Device | 2014 | 532 |
| K142050 | Nuvasive Coroent Small Contoured Interbody System | 2014 | 449 |
| K140921 | Coroent Small Interbody System | 2014 | 444 |
| K133653 | Anatomic Peek PTC Cervical Fusion System | 2014 | 286 |
| K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | 2015 | 280 |
| K142079 | Stalif Cti, Stalif C | 2014 | 276 |
| K142251 | AVS AS PEEK Spacer | 2014 | 161 |
| K153373 | CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical… | 2016 | 110 |
| K140417 | Divergence Mini-Plate Anterior Cervical Fusion System | 2014 | 11 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
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?
- Of its descendants, K142264 (Amedica Corp., 2014) has gone furthest, with 532 descendants of its own.
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. 2013, 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 ANATOMIC PEEKTM CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplatcs producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic…
Read the full statement (128 words)
The ANATOMIC PEEKTM CERVICAL FUSION SYSTEM is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myclopathy with herniated disc and/or osteophyte formation on posterior vertebral endplatcs producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEKTM device is to be used with supplemental fixation. The ANATOMIC PEEK"" CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130177: Anatomic Peek Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130177
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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