510(k) · Cleared
ClearedCETRA Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Dec 16, 2016 as substantially equivalent to K100614 (Blackstone Medical, Inc., 2010) and 3 other predicates after an 85-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 16, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K922087 (1992). 33 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 5 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 4 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 3 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 2 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 1 generation backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- This deviceK162638 CETRA Anterior Cervical Plate SystemOrthofix, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK240935 ARENAL Anterior Cervical Plate SystemEffortmed, LLC · 2024
- Descendant · cites it directly · 0 of its ownK211712 3° Anterior Cervical Plating System, Reliant Anterior Cervical…Orthofix US, LLC · 2022
- Descendant · cites it directly · 0 of its ownK181190 Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019
Most influential descendants
Showing 3 of 3 · See all- K240935ARENAL Anterior Cervical Plate SystemEffortmed, LLC · 2024 · cites it directly0descendants
- K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity…Orthofix US, LLC · 2022 · cites it directly0descendants
- K181190Pinehurst Anterior Cervical Plate SystemSignature Orthopaedics Pty, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −6 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −5 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −4 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −3 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −2 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −1 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| 0 (this device) | K162638 | CETRA Anterior Cervical Plate System | Orthofix, Inc. | 2016 | — |
| +1 | K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | 2024 | — |
| +1 | K211712 | 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System… | Orthofix US, LLC | 2022 | — |
| +1 | K181190 | Pinehurst Anterior Cervical Plate System | Signature Orthopaedics Pty, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 4…ct Code: KWQ Regulatory Classification: Class Il — 21 CFR § 888.3060 Review Panel: Orthopedic Device Panel Primary Predicate: Hallmark Anterior Cervical Plate System — K100614 - Orthofix Additional Predicates: Reliant Anterior Cervical Plate System — K030595 - Orthofix SLIM*LOC Anterior Cervical Plate S… | 2010 |
| * | K030595 | Blackstone Fusion Anterior Cervical Plating SystemSummary page 4…: Orthopedic Device Panel Primary Predicate: Hallmark Anterior Cervical Plate System — K100614 - Orthofix Additional Predicates: Reliant Anterior Cervical Plate System — K030595 - Orthofix SLIM*LOC Anterior Cervical Plate System — K013877 — Depuy Codman & Shurtleff, Inc. MaxAn Anterior Cervical Plate Syst… | 2003 |
| * | K013877 | Codman Slim-Loc SystemSummary page 4…Cervical Plate System — K100614 - Orthofix Additional Predicates: Reliant Anterior Cervical Plate System — K030595 - Orthofix SLIM*LOC Anterior Cervical Plate System — K013877 — Depuy Codman & Shurtleff, Inc. MaxAn Anterior Cervical Plate System — K133518 - Biomet Reason for 510(k) Submission: Orthofix… | 2001 |
| * | K133518 | Maxan Anterior Cervical Plate SystemSummary page 4…ior Cervical Plate System — K030595 - Orthofix SLIM*LOC Anterior Cervical Plate System — K013877 — Depuy Codman & Shurtleff, Inc. MaxAn Anterior Cervical Plate System — K133518 - Biomet Reason for 510(k) Submission: Orthofix is submitting this Traditional 510(k) premarket notification for the introductio… | 2014 |
What descends from it? (3)
3 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 24 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 33 ancestors have a recall of any class.
- Of its descendants, K240935 (Effortmed, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K100614.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:
a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);
b) Spondylolisthesis;
c) Fracture;
d) Spinal Stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
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/K162638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162638: CETRA Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162638
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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