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 Apr 28, 2014 as substantially equivalent to K130177 (Medtronic Sofamor Danek USA, Inc., 2013) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 2001. 286 later devices descend from it.
- Decided
- Apr 28, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to P980048 (2001). 5 ancestors in all. 286 later devices descend from it, 5 citing it directly.
- Root · 2 generations backP980048 Bak/Cervical (Bak/C) Interbody Fusion SystemSulzer Spine-Tech · 2001
- 1 generation backK112036 Calix PC Spinal Implant SystemX-Spine Systems, Inc. · 2011
- This deviceK133653 Anatomic Peek PTC Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2014
- Descendant · cites it directly · 280 of its ownK142152 Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand…Orthofix, Inc. · 2015
- Descendant · 2 generations on · 202 of its ownK150788 Talos Intervertebral Body Fusion Devices, Talos -C Cervical…Meditech Spine, LLC · 2015
- Descendant · 3 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 4 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 2 generations on · 107 of its ownK150619 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015
Showing 5 of 286 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 286 · See all- K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc. · 2015 · cites it directly280descendants
- K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC · 2015 · 2 generations on202descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 3 generations on166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 4 generations on129descendants
- K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc. · 2015 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980048 | Bak/Cervical (Bak/C) Interbody Fusion System | Sulzer Spine-Tech | 2001 | — |
| −1 | K112036 | Calix PC Spinal Implant System | X-Spine Systems, Inc. | 2011 | — |
| 0 (this device) | K133653 | Anatomic Peek PTC Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| +1 | K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | Orthofix, Inc. | 2015 | — |
| +2 | K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral… | Meditech Spine, LLC | 2015 | — |
| +3 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +4 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +2 | K150619 | CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System | Orthofix, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 16 | 0 |
| 2018 | 14 | 0 |
| 2019 | 21 | 0 |
| 2020 | 23 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 32 | 0 |
| 2024 | 39 | 0 |
| 2025 | 47 | 0 |
| 2026 | 36 | 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? (3)
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 | K112444 | FDA’s K112444 is Anatomic Peek Cervical Fusion System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K130177 | Anatomic Peek Cervical Fusion SystemSummary page 3…as the same indications for use and fundamental scientific technology as the predicate, ANATOMIC PEEK Cervical Fusion System (K] 12444, SE 11/15/2011 and K1301 77, SE 09/23/2013). An additional predicate, X-Spine's CalixTM PC Systema (KI 12036, SE 11/8/2011 ). is al… | 2013 |
| * | K112036 | Calix PC Spinal Implant System | 2011 |
What descends from it? (286)
See all 2865 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142152 | Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System | 2015 | 280 |
| K160528 | ANATOMIC PEEK PTC Cervical Fusion System | 2016 | 23 |
| K180590 | Tyber Medical PT Interbody Spacer System | 2018 | 6 |
| K192502 | Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System… | 2020 | 4 |
| K172568 | Cervage | 2018 | 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 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K142152 (Orthofix, Inc., 2015) has gone furthest, with 280 descendants of its own.
- 9 other devices also cite its predicate K130177.
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 ANATOMIC PEEK PTC 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-T1 disc. Cervical disc disease is defined as intractable radiculopatby and/or myelopathy with herniated disc and/or osteophyte fonmation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic…
Read the full statement (131 words)
The ANATOMIC PEEK PTC 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-T1 disc. Cervical disc disease is defined as intractable radiculopatby and/or myelopathy with herniated disc and/or osteophyte fonmation on posterior vertebral endplates 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 PEEK PTC device is to be used with supplemental fixation. The ANATOMIC PEEK PTC 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133653: 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/K133653
Report an extraction error
Are you the manufacturer?
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