510(k) · Cleared
ClearedFormus Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Formus Labs, Ltd. · QIH Automated Radiological Image Processing Software
Cleared on Mar 31, 2023 as substantially equivalent to K182464 (Peek Health, S.A., 2018) after a 547-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Mar 31, 2023
- Review
- 547 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK182464 PeekMedPeek Health, S.A. · 2018
- This deviceK213272 Formus HipFormus Labs, Ltd. · 2023
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 5 generations backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- 4 generations backK032401 OrthoviewOmsbar, Ltd. · 2003
- 3 generations backK042816 Traumacad 1.2Orthocrat, Ltd. · 2004
- 2 generations backK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- 1 generation backK182464 PeekMedPeek Health, S.A. · 2018
- This deviceK213272 Formus HipFormus Labs, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −5 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| −4 | K032401 | Orthoview | Omsbar, Ltd. | 2003 | — |
| −3 | K042816 | Traumacad 1.2 | Orthocrat, Ltd. | 2004 | — |
| −2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| −1 | K182464 | PeekMed | Peek Health, S.A. | 2018 | — |
| 0 (this device) | K213272 | Formus Hip | Formus Labs, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 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 |
|---|---|---|---|
| * | K182464 | PeekMedSummary page 4…ware Regulation: 21 CFR §892.2050 Regulatory Class: II Product Code: QIH 3. PREDICATE DEVICE PeekMed (K182464) This predicate has not been subject to a design-related recall. 4. DEVICE DESCRIPTION Formus Hip is a semi-automa… | 2018 |
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 33 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 22 ancestors have a recall of any class.
- 5 other devices also cite its predicate K182464.
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. 2023, 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?
Formus Hip is a pre-operative planning software for orthopedic surgery. The standalone software application imports patient diagnostic imaging studies (e.g. pre-dimensioned CT scans) from PACS-systems or other conventional medias. The Formus Hip system contains an integrated database of orthopedic hip implant geometries that can be overlayed to assist surgeons in their planning of orthopedic hip surgeries. The software application further enables the…
Read the full statement (118 words)
Formus Hip is a pre-operative planning software for orthopedic surgery. The standalone software application imports patient diagnostic imaging studies (e.g. pre-dimensioned CT scans) from PACS-systems or other conventional medias. The Formus Hip system contains an integrated database of orthopedic hip implant geometries that can be overlayed to assist surgeons in their planning of orthopedic hip surgeries. The software application further enables the healthcare professional to customize their preoperative planning by means of an interactive graphical user interface. Finalized plans can be printed to a PDF report. The qualified healthcare professional can digitally perform the surgical planning and also make it available as a printable report. Clinical judgment and experience with the software are required for its successful use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213272: Formus Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213272
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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