510(k) · Cleared
ClearedJointPoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jointpoint, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 3, 2016 as substantially equivalent to K022364 (Orthosoft, Inc., 2003) and 3 other predicates after a 182-day review. Its family tree reaches back 9 generations to 1990. 21 later devices descend from it.
- Decided
- Aug 3, 2016
- Review
- 182 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K896095 (1990). 24 ancestors in all. 21 later devices descend from it, 7 citing it directly.
- 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 backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- This deviceK160284 JointPointJointpoint, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK182332 PhantomMSKOrthoGrid Systems, Inc. · 2019
- Descendant · cites it directly · 4 of its ownK201928 e-Ortho Shoulder SoftwareFH Industrie · 2020
- Descendant · cites it directly · 3 of its ownK203651 CuptimizeCuptimize, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK210136 PhantomMSK HipOrthoGrid Systems, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK213922 FX SPSPixee Medical · 2022
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 backK142923 TraumaCad Mobile Release 1.0Voyant Health, Ltd. · 2015
- This deviceK160284 JointPointJointpoint, Inc. · 2016
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K182332PhantomMSKOrthoGrid Systems, Inc. · 2019 · cites it directly5descendants
- K201928e-Ortho Shoulder SoftwareFH Industrie · 2020 · cites it directly4descendants
- K203651CuptimizeCuptimize, Inc. · 2021 · cites it directly3descendants
- K210136PhantomMSK HipOrthoGrid Systems, Inc. · 2021 · 2 generations on3descendants
- K213922FX SPSPixee Medical · 2022 · 2 generations on2descendants
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 | K142923 | TraumaCad Mobile Release 1.0 | Voyant Health, Ltd. | 2015 | — |
| 0 (this device) | K160284 | JointPoint | Jointpoint, Inc. | 2016 | — |
| +1 | K182332 | PhantomMSK | OrthoGrid Systems, Inc. | 2019 | — |
| +1 | K201928 | e-Ortho Shoulder Software | FH Industrie | 2020 | — |
| +1 | K203651 | Cuptimize | Cuptimize, Inc. | 2021 | — |
| +2 | K210136 | PhantomMSK Hip | OrthoGrid Systems, Inc. | 2021 | — |
| +2 | K213922 | FX SPS | Pixee Medical | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K022364 | Navitrack System Total Hip Replacement,Model 900.200Summary page 5…will still function in an OR that does not have internet connectivity. Predicate Devices: JointPoint is substantially equivalent to ORTHOsoft, Inc. NavitrackTM System (K022364) and TraumaCad (K142923, K073714, K042816). Substantial Equivalence: Testing performed on this device demonstrates that JointPoi… | 2003 |
| * | K142923 | TraumaCad Mobile Release 1.0Summary page 5…an OR that does not have internet connectivity. Predicate Devices: JointPoint is substantially equivalent to ORTHOsoft, Inc. NavitrackTM System (K022364) and TraumaCad (K142923, K073714, K042816). Substantial Equivalence: Testing performed on this device demonstrates that JointPoint is substantially equi… | 2015 |
| * | K073714 | Traumacad Version 2.0Summary page 5…t does not have internet connectivity. Predicate Devices: JointPoint is substantially equivalent to ORTHOsoft, Inc. NavitrackTM System (K022364) and TraumaCad (K142923, K073714, K042816). Substantial Equivalence: Testing performed on this device demonstrates that JointPoint is substantially equivalent to… | 2008 |
| * | K042816 | Traumacad 1.2Summary page 5…t have internet connectivity. Predicate Devices: JointPoint is substantially equivalent to ORTHOsoft, Inc. NavitrackTM System (K022364) and TraumaCad (K142923, K073714, K042816). Substantial Equivalence: Testing performed on this device demonstrates that JointPoint is substantially equivalent to the pred… | 2004 |
What descends from it? (21)
See all 217 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)
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 26 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K182332 (OrthoGrid Systems, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K022364.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. JointPoint is also indicated for assisting healthcare professionals in preoperative…
Read the full statement (133 words)
JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
JointPoint is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160284: JointPoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160284
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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