510(k) · Cleared
Recalled · 2007Impax Orthopaedic Workstation, Model Impax ES 5.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · LLZ System, Image Processing, Radiological
Cleared on Apr 21, 2005 as substantially equivalent to K014113 (Siemens Medical Solutions USA, Inc., 2002) after a 29-day review. Its family tree reaches back 2 generations to 2001. 135 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 21, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010612 (2001). 3 ancestors in all. 135 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 1 generation backK014113 EndomapSiemens Medical Solutions USA, Inc. · 2002
- This deviceK050751 Impax Orthopaedic Workstation, Model Impax ES 5.XAgfa Corp. · 2005
- Descendant · cites it directly · 133 of its ownK071972 Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007
- Descendant · 2 generations on · 117 of its ownK073714 Traumacad Version 2.0Orthocrat, Ltd. · 2008
- Descendant · 3 generations on · 51 of its ownK111019 Surgimap (TM) SpineNemaris, Inc. · 2011
- Descendant · 3 generations on · 28 of its ownK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- Descendant · 3 generations on · 27 of its ownK141669 SurgimapNemaris, Inc. · 2014
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K071972Orthopedic Software for Impax WorkstationsAgfa Healthcare Corp. · 2007 · cites it directly133descendants
- K073714Traumacad Version 2.0Orthocrat, Ltd. · 2008 · 2 generations on117descendants
- K111019Surgimap (TM) SpineNemaris, Inc. · 2011 · 3 generations on51descendants
- K142923TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015 · 3 generations on28descendants
- K141669SurgimapNemaris, Inc. · 2014 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −1 | K014113 | Endomap | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K050751 | Impax Orthopaedic Workstation, Model Impax ES 5.X | Agfa Corp. | 2005 | — |
| +1 | K071972 | Orthopedic Software for Impax Workstations | Agfa Healthcare Corp. | 2007 | — |
| +2 | K073714 | Traumacad Version 2.0 | Orthocrat, Ltd. | 2008 | — |
| +3 | K111019 | Surgimap (TM) Spine | Nemaris, Inc. | 2011 | — |
| +3 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| +3 | K141669 | Surgimap | Nemaris, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 11 | 0 |
| 2022 | 9 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 24 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K014113 | EndomapSummary page 1…g of orthopedic surgeries. 5. Substantial Equivalence The IMPAX® OT3000 orthopedic component is substantially equivalent to the Siemens' EndoMap (FDA Clearance # K014113; Clearance Date: 06/14/2002). The Diagnostic Workstation was previously submitted for FDA approval (K022292; Clearance D… | 2002 |
| † | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology… | 2002 |
| † | K993532 | DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (Amongst Other Names) | 1999 |
What descends from it? (135)
See all 1352 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2007 | Not classified | Z-1245-2008 | Software design | Text and Images may not be synchronized. |
| May 14, 2007 | Not classified | Z-1243-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
| May 14, 2007 | Not classified | Z-1244-2008 | Software change control | Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K071972 (Agfa Healthcare Corp., 2007) has gone furthest, with 133 descendants of its own.
- 1 other device also cites its predicate K014113.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic PACS application provides digital planning to images acquired through the system. These images can be utilized to place digital templates that reflect actual prosthetic implants…
Read the full statement (131 words)
The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment.
As an add-on component to the IMPAX client, the OT3000 orthopedic PACS application provides digital planning to images acquired through the system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can also be shown to patients to explain the procedure they will undergo and to help them understand the pathology present.
The application consists of an Impax Diagnostic Workstation and templates. Templates are patterns or guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050751: Impax Orthopaedic Workstation, Model Impax ES 5.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050751
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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