510(k) · Cleared
ClearedTECHFIT Diagnostic Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techfit Digital Surgery, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2023 as substantially equivalent to K183105 (Materialise NV, 2019) after a 134-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jan 6, 2023
- Review
- 134 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK073468 MimicsMaterialise NV · 2008
- 1 generation backK183105 Mimics MedicalMaterialise NV · 2019
- This deviceK222577 TECHFIT Diagnostic ModelsTechfit Digital Surgery, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K073468 | Mimics | Materialise NV | 2008 | — |
| −1 | K183105 | Mimics Medical | Materialise NV | 2019 | — |
| 0 (this device) | K222577 | TECHFIT Diagnostic Models | Techfit Digital Surgery, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K183105 | Mimics MedicalSummary page 4…892.2050 Predicate device information: Trade name Materialise N.V. 510(k) number K183105 Common or Usual name Mimics Medical Classification name System, Image Processing… | 2019 |
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 30 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 6 ancestors has a recall.
- 16 other devices also cite its predicate K183105.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery. The input data file (DICOM imaging information from a medical scanner file) is processed by commercial off-the-shelf software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing.…
Read the full statement (112 words)
The TECHFIT Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery.
The input data file (DICOM imaging information from a medical scanner file) is processed by commercial off-the-shelf software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing.
The physical replica can be used for diagnostic purposes in the field of, maxillofacial applications.
TECHFIT Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment.
TECHFIT Diagnostic Models are not intended to enter the operating room
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222577 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222577: TECHFIT Diagnostic Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222577
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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