510(k) · Cleared
ClearedCMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Instruments, Inc. · HRS Plate, Fixation, Bone
Cleared on May 23, 1995 after a 155-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- May 23, 1995
- Review
- 155 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK946165 CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation…Elekta Instruments, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK992682 Modus 2.5 Mandibular Reconstruction SetMedartis AG · 1999
- Descendant · cites it directly · 2 of its ownK992683 Modus 2.5 Mandibular Trauma SetMedartis AG · 1999
- Descendant · cites it directly · 1 of its ownK050934 Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK071612 Modus Trilock 2.0/2.3/2.5Medartis AG · 2007
- Descendant · 2 generations on · 0 of its ownK013672 Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC · 2002
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992682Modus 2.5 Mandibular Reconstruction SetMedartis AG · 1999 · cites it directly2descendants
- K992683Modus 2.5 Mandibular Trauma SetMedartis AG · 1999 · cites it directly2descendants
- K050934Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005 · cites it directly1descendant
- K071612Modus Trilock 2.0/2.3/2.5Medartis AG · 2007 · 2 generations on0descendants
- K013672Bruges Distraction - Anchoring - Osteosynthesis SystemAzary Technologies, LLC · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946165 | CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System | Elekta Instruments, Inc. | 1995 | — |
| +1 | K992682 | Modus 2.5 Mandibular Reconstruction Set | Medartis AG | 1999 | — |
| +1 | K992683 | Modus 2.5 Mandibular Trauma Set | Medartis AG | 1999 | — |
| +1 | K050934 | Modus Titanium Osteosynthesis System | Medartis, Inc. | 2005 | — |
| +2 | K071612 | Modus Trilock 2.0/2.3/2.5 | Medartis AG | 2007 | — |
| +2 | K013672 | Bruges Distraction - Anchoring - Osteosynthesis System | Azary Technologies, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
4 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?
- Of its descendants, K992682 (Medartis AG, 1999) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
https://510kreport.com/device/K946165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K946165: CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K946165
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026