510(k) · Cleared
ClearedROSA Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthosoft Inc (D/B/A Zimmer Cas) · LLZ System, Image Processing, Radiological
Cleared on May 23, 2023 as substantially equivalent to K210998 (Orthosoft D/B/A Zimmer Cas, 2021) after a 29-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- May 23, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K905070 (1991). 83 ancestors in all, the oldest K811452 (1981). No later device cites it as a predicate yet.
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 11 generations between
- 3 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 2 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK210998 ROSA Hip SystemOrthosoft D/B/A Zimmer Cas · 2021
- This deviceK231162 ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2023
Show all 15 generations
- Root · 15 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 14 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 13 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 12 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 11 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 10 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 9 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 8 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 7 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 6 generations backK112507 Restoris Partial Knee Application (Pka), Rio Standard SystemMako Surgical Corporation · 2012 · Recalled
- 5 generations backK143752 Total Knee Application (TKA)Mako Surgical Corp. · 2015 · Recalled
- 4 generations backK170581 Mako Total Knee ApplicationMako Surgical Corp. · 2017 · Recalled
- 3 generations backK172219 Mako Total Knee ApplicationMako Surgical Corp. · 2017
- 2 generations backK182964 ROSA Knee SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2019
- 1 generation backK210998 ROSA Hip SystemOrthosoft D/B/A Zimmer Cas · 2021
- This deviceK231162 ROSA Hip SystemOrthosoft Inc (D/B/A Zimmer Cas) · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −14 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −13 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −12 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −11 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −10 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −9 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −8 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −7 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −6 | K112507 | Restoris Partial Knee Application (Pka), Rio Standard System | Mako Surgical Corporation | 2012 | 6 |
| −5 | K143752 | Total Knee Application (TKA) | Mako Surgical Corp. | 2015 | 2 |
| −4 | K170581 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | 1 |
| −3 | K172219 | Mako Total Knee Application | Mako Surgical Corp. | 2017 | — |
| −2 | K182964 | ROSA Knee System | Orthosoft Inc (D/B/A Zimmer Cas) | 2019 | — |
| −1 | K210998 | ROSA Hip System | Orthosoft D/B/A Zimmer Cas | 2021 | — |
| 0 (this device) | K231162 | ROSA Hip System | Orthosoft Inc (D/B/A Zimmer Cas) | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 6 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K210998 | ROSA Hip SystemSummary page 4…redicate Device(s): Manufacturer Device Name 510(k) Number Predicate or Reference Zimmer CAS ROSA® Hip System K210998 Predicate K231162 - Page 2 of 4 Purpose a… | 2021 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 22 of the 83 ancestors have a recall of any class.
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 ROSA® Hip System for use with the ROSA® RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images. The intraoperative cup…
Read the full statement (186 words)
The ROSA® Hip System for use with the ROSA® RECON platform, is indicated as a fluoroscopic-guided system for total hip arthroplasty (THA). It is used to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of hip implant components provided that the points of interest can be identified from radiology images.
The intraoperative cup placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on preoperative planning values optionally determined using compatible X-Ray based surgical planning tools.
The ROSA® Hip System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA® Hip System. The ROSA® Hip System is not for primary image interpretation and is applicable for the direct anterior approach.
The ROSA® Hip System is to be used with the following hip replacement systems in accordance with their indications and contraindications: G7® Acetabular System, Avenir® Hip System, Avenir Complete™ Hip System, Taperloc® Complete Hip System, Echo® Hip System.
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/K231162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231162: ROSA Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231162
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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