510(k) · Cleared
ClearedAIAS Cephalon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metamorphosis GmbH · QIH Automated Radiological Image Processing Software
Cleared on Oct 7, 2025 as substantially equivalent to K210136 (OrthoGrid Systems, Inc., 2021) after an 84-day review. Its family tree reaches back 12 generations to 1990.
- Decided
- Oct 7, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K896095 (1990). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations between
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK182332 PhantomMSKOrthoGrid Systems, Inc. · 2019
- 1 generation backK210136 PhantomMSK HipOrthoGrid Systems, Inc. · 2021
- This deviceK252214 AIAS CephalonMetamorphosis GmbH · 2025
Show all 12 generations
- Root · 12 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 11 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 10 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 9 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 8 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 7 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 6 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 5 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 4 generations backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- 3 generations backK160284 JointPointJointpoint, Inc. · 2016
- 2 generations backK182332 PhantomMSKOrthoGrid Systems, Inc. · 2019
- 1 generation backK210136 PhantomMSK HipOrthoGrid Systems, Inc. · 2021
- This deviceK252214 AIAS CephalonMetamorphosis GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −11 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −10 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −9 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −8 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −7 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −6 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −5 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −4 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| −3 | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| −2 | K182332 | PhantomMSK | OrthoGrid Systems, Inc. | 2019 | — |
| −1 | K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | 2021 | — |
| 0 (this device) | K252214 | AIAS Cephalon | Metamorphosis GmbH | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K210136 | PhantomMSK HipSummary page 5…ication Name: Automated radiological image processing software Regulation Number: 892.2050 Product Code QIH Predicate Device: PhantomMSK Hip (K210136) Device Description Summary: AIAS Cephalon is a fully automated software as a medical device (SaMD) that provides image analysis… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 9 companies; a new generation was cleared every 2.5 years on median.
- 5 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K210136.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
AIAS Cephalon is an image-processing software indicated to assist in the positioning of femur fracture implant components for adult patients. It is intended to assist in precisely positioning femur fracture implant components intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images (C-arm images). Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252214 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252214: AIAS Cephalon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252214
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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