510(k) · Cleared
ClearedPhilips Orthopaedic Applications
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 2, 2004 as substantially equivalent to K040344 (Agfa Corp., 2004) and 1 other predicate after a 15-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Nov 2, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913475 (1991). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 4 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 3 generations backK971965 Philips EasyvisionPhilips Medical Systems, Inc. · 1998
- 2 generations backK022292 Impax Diagnostic Display Station,Impax Clinical Review Station,Impax…Agfa Corp. · 2002 · Recalled
- 1 generation backK040344 Impax OT3000 Orthopedic WorkstationAgfa Corp. · 2004
- This deviceK042867 Philips Orthopaedic ApplicationsPhilips Medical Systems North America, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK060210 MediportMaxant Technologies, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060210MediportMaxant Technologies, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −4 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −3 | K971965 | Philips Easyvision | Philips Medical Systems, Inc. | 1998 | — |
| −2 | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for… | Agfa Corp. | 2002 | 9 |
| −1 | K040344 | Impax OT3000 Orthopedic Workstation | Agfa Corp. | 2004 | — |
| 0 (this device) | K042867 | Philips Orthopaedic Applications | Philips Medical Systems North America, Inc. | 2004 | — |
| +1 | K060210 | Mediport | Maxant Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K040344 | Impax OT3000 Orthopedic Workstation Our reading of the summary gave K040334, FDA’s number for Navigus Passive Probe, Model NP-1000 (Image-Guided Neurologics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Agfa IMPAX® OT3000 Orthopedic Workstation”. | 2004 |
| * | K031590 | Sectra Orthopedic PackageSummary page 2…the Orthopaedic Applications to be substantially equivalent to the Agfa IMPAX® OT3000 Orthopedic Workstation (K040334) and the Sectra Orthopedic Package (K031590). DEPARTMENT OFFHEALTH & HUMAN SERVICES Public Health Service… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060210 | Mediport | 2006 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K060210 (Maxant Technologies, Inc., 2006) has gone furthest, with 0 descendants of its own.
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?
Philips Orthopaedic Applications is a suite of software applications designed
to assist medical professionals such as orthopaedic surgeons, physicians and
radiologists in planning and evaluating orthopaedic procedures using medical
images.
The applications are intended to view and manipulate 2D and 3D medical
images; to calibrate and make length, angle and area measurements on such
images; to represent and manipulate surgical planning templates overlaid on
such images; to plan and simulate the effect of treatments by transforming
such images; and to print and store the results of these measurements and
simulations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042867: Philips Orthopaedic Applications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042867
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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