510(k) · Cleared
ClearedANATOMIC PEEK PTC 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 Mar 28, 2016 as substantially equivalent to K142264 (Amedica Corp., 2014) and 1 other predicate after a 32-day review. Its family tree reaches back 3 generations to 2001. 23 later devices descend from it.
- Decided
- Mar 28, 2016
- Review
- 32 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to P980048 (2001). 7 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 3 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 2 generations backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- 1 generation backK133653 Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK160528 ANATOMIC PEEK PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · cites it directly · 15 of its ownK171075 Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017
- Descendant · 2 generations on · 9 of its ownK202398 Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021
- Descendant · 2 generations on · 9 of its ownK202305 Zavation IBF SystemZavation Medical Products, LLC · 2020
- Descendant · 3 generations on · 6 of its ownK221049 Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022
- Descendant · cites it directly · 4 of its ownK192502 Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical…Medtronic Sofamor Danek USA, Inc. · 2020
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc. · 2017 · cites it directly15descendants
- K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC · 2021 · 2 generations on9descendants
- K202305Zavation IBF SystemZavation Medical Products, LLC · 2020 · 2 generations on9descendants
- K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC · 2022 · 3 generations on6descendants
- K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc. · 2020 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −2 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| −1 | K133653 | Anatomic Peek PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K160528 | ANATOMIC PEEK PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +1 | K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | 2017 | — |
| +2 | K202398 | Ti3Z Cervical Interbody System | Zavation Medical Products, LLC | 2021 | — |
| +2 | K202305 | Zavation IBF System | Zavation Medical Products, LLC | 2020 | — |
| +3 | K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | 2022 | — |
| +1 | K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion… | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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.
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? (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 |
|---|---|---|---|
| * | K142264 | Valeo C Spacer System, Valeo II C IBF DeviceSummary page 4…0 Regulation Name and Device Intervertebral Body Fusion Device Product Classification Code ODP Predicate Devices 1) Valeo Spacer System-C and VALEO® II-C (K142264, SE 12/08/14 – Primary Predicate) 2) ANATOMIC PEEK™ PTC Cer… | 2014 |
| * | K133653 | Anatomic Peek PTC Cervical Fusion SystemSummary page 4…ALEO® II-C (K142264, SE 12/08/14 – Primary Predicate) 2) ANATOMIC PEEK™ PTC Cervical Fusion System (K133653, SE 04/28/14) The predicate devices have not been subject to a d… | 2014 |
What descends from it? (23)
See all 233 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 15 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K171075 (X-Spine Systems, Inc., 2017) has gone furthest, with 15 descendants of its own.
- 7 other devices also cite its predicate K142264.
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. 2016, 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 PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the…
Read the full statement (133 words)
The ANATOMIC PEEK™ PTC Cervical Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The ANATOMIC PEEK™ PTC Cervical Fusion System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The ANATOMIC PEEK™ PTC Cervical Fusion System is to be used with supplemental fixation. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160528: ANATOMIC PEEK PTC Cervical Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160528
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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