510(k) · Cleared
ClearedHipCheck
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · LLZ System, Image Processing, Radiological
Cleared on Dec 13, 2018 as substantially equivalent to K132636 (Smith & Nephew, Inc., 2013) and 1 other predicate after a 105-day review. Its family tree reaches back 10 generations to 1994. 1 of the 47 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 13, 2018
- Review
- 105 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K911783 (1994). 45 ancestors in all, the oldest K811452 (1981). 1 later device descends from it, 1 citing it directly. 1 of the 47 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations between
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- This deviceK182359 HipCheckStryker Corp. · 2018
- Descendant · cites it directly · 0 of its ownK230045 HipCheckStryker Corp. · 2023
Show all 10 generations
- Root · 10 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 9 generations backK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
- 8 generations backK964229 Regulus NavigatorCompass Intl., Inc. · 1997
- 7 generations backK981315 NavitrackOrthosoft, Inc. · 1998
- 6 generations backK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
- 5 generations backK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
- 4 generations backK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007
- 3 generations backK073467 Spineassist SystemMazor Surgical Technologies, Ltd. · 2008
- 2 generations backK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
- 1 generation backK103400 Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt)…Stryker Corporation · 2011
- This deviceK182359 HipCheckStryker Corp. · 2018
Class I recalls in this family
- K003837 Flexiview 8800 Digital Mobile Imaging System5 generations back · 2001
Most influential descendants
Showing 1 of 1 · See all- K230045HipCheckStryker Corp. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −9 | K960714 | Isg Viewing Wand | I.S.G. Technologies, Inc. | 1996 | — |
| −8 | K964229 | Regulus Navigator | Compass Intl., Inc. | 1997 | — |
| −7 | K981315 | Navitrack | Orthosoft, Inc. | 1998 | — |
| −6 | K033413 | Spineassist Device | Mazor Surgical Technologies, Ltd. | 2004 | — |
| −5 | K051676 | Spineassist Device with Additional Accessories | Mazor Surgical Technologies, Ltd. | 2005 | — |
| −4 | K063607 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2007 | — |
| −3 | K073467 | Spineassist System | Mazor Surgical Technologies, Ltd. | 2008 | — |
| −2 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
| −1 | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip | Stryker Corporation | 2011 | — |
| 0 (this device) | K182359 | HipCheck | Stryker Corp. | 2018 | — |
| +1 | K230045 | HipCheck | Stryker Corp. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 1 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K132636 | Dyonics Plan Hip Impingement Planning SystemSummary page 4…0) Regulatory Class: II Product Code: LLZ III. PREDICATE DEVICES Primary Predicate: Dyonics Plan Hip Impingement Planning Software, K132636 Secondary Predicate: FluoroMap Computer Assisted Surgery System, K103400 Neither predicate has been su… | 2013 |
| * | K103400 | Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube ClipSummary page 4…Primary Predicate: Dyonics Plan Hip Impingement Planning Software, K132636 Secondary Predicate: FluoroMap Computer Assisted Surgery System, K103400 Neither predicate has been subject to a design-related recall. IV. DEVICE DESCRIPTION HipCheck enables the… | 2011 |
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 |
|---|---|---|---|
| K230045 | HipCheck | 2023 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 5 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 8 of the 45 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K230045 (Stryker Corp., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132636.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
HipCheck provides static localization information derived from image processing of intra-operatively acquired X-ray images, by superposition of virtual measurement tools onto those X-ray images.
HipCheck assists the surgeon to determine quantitative measurements during femoroacetabular impingement procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182359: HipCheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182359
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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