510(k) · Cleared
ClearedOrthofix Acp (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 Jul 20, 2012 as substantially equivalent to K050892 (Blackstone Medical, Inc., 2005) and 3 other predicates after a 45-day review. Its family tree reaches back 8 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 20, 2012
- Review
- 45 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K922087 (1992). 42 ancestors in all, the oldest K831246 (1983). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 7 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 6 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 5 generations backK043066 Pioneer Anterior Cervical Plate SystemPioneer Surgical Technology · 2005
- 4 generations backK053053 Pacp SystemPioneer Surgical Technology · 2005
- 3 generations backK072703 Pioneer Slimfuse Anterior Cervical Plating SystemPioneer Surgical Technology · 2008
- 2 generations backK100708 Pioneer Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology · 2010
- 1 generation backK111528 Pioneer Aspect Anterior Cervical Plate Model 24-SeriesPioneer Surgical Technology, Inc. · 2011
- This deviceK121658 Orthofix Acp (Anterior Cervical Plate System)Orthofix, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK191786 Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK130825 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK213901 Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022
- Descendant · 2 generations on · 0 of its ownK143028 Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K191786Cyclops™ Anterior Cervical Plate SystemDegen Medical, Inc. · 2019 · cites it directly1descendant
- K130825Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2013 · cites it directly1descendant
- K213901Cyclops™ Anterior Cervical Plate SystemDegen Medical · 2022 · 2 generations on0descendants
- K143028Azure Anterior Cervical Plate SystemOrthofix, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −7 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −6 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −5 | K043066 | Pioneer Anterior Cervical Plate System | Pioneer Surgical Technology | 2005 | — |
| −4 | K053053 | Pacp System | Pioneer Surgical Technology | 2005 | — |
| −3 | K072703 | Pioneer Slimfuse Anterior Cervical Plating System | Pioneer Surgical Technology | 2008 | — |
| −2 | K100708 | Pioneer Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology | 2010 | — |
| −1 | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-Series | Pioneer Surgical Technology, Inc. | 2011 | — |
| 0 (this device) | K121658 | Orthofix Acp (Anterior Cervical Plate System) | Orthofix, Inc. | 2012 | — |
| +1 | K191786 | Cyclops™ Anterior Cervical Plate System | Degen Medical, Inc. | 2019 | — |
| +1 | K130825 | Azure Anterior Cervical Plate System | Orthofix, Inc. | 2013 | 1 |
| +2 | K213901 | Cyclops™ Anterior Cervical Plate System | Degen Medical | 2022 | — |
| +2 | K143028 | Azure Anterior Cervical Plate System | Orthofix, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K050892 | Hallmarktm Anterior Cervical Plate SystemSummary page 1…ervertebral body fixation orthosis Review Panel: Orthopedic Device Panel Predicate Devices: Hallmark Anterior Cervical Plate System (K050892 and K100614), DePuy/Codman & Shurtleff, Inc. SLIM LOC Anterio… | 2005 |
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 1…el: Orthopedic Device Panel Predicate Devices: Hallmark Anterior Cervical Plate System (K050892 and K100614), DePuy/Codman & Shurtleff, Inc. SLIM LOC Anterior Cervical Plate System (K013877), Pioneer Asp… | 2010 |
| * | K013877 | Codman Slim-Loc SystemSummary page 1…System (K050892 and K100614), DePuy/Codman & Shurtleff, Inc. SLIM LOC Anterior Cervical Plate System (K013877), Pioneer Aspect Anterior Cervical Plate (K 11 1528) Reason for 51 0(k) Submission: New produc… | 2001 |
| * | K111528 | Pioneer Aspect Anterior Cervical Plate Model 24-SeriesSummary page 1…leff, Inc. SLIM LOC Anterior Cervical Plate System (K013877), Pioneer Aspect Anterior Cervical Plate (K 11 1528) Reason for 51 0(k) Submission: New product offering… | 2011 |
What descends from it? (4)
2 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 20 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K191786 (Degen Medical, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K050892.
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. 2012, 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 Orthofix Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for
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) Trauma (i.e., fracture or dislocation);
d) Spinal stenosis;
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor;
g) Pseudoarthrosis;
h) Revision of previous surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121658: Orthofix Acp (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/K121658
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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