510(k) · Cleared
ClearedRPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Instruments · OLO Orthopedic Stereotaxic Instrument
Cleared on Sep 25, 2025 as substantially equivalent to K240139 (Blue Belt Technologies, Inc., 2024) after a 91-day review. Its family tree reaches back 24 generations to 1991.
- Decided
- Sep 25, 2025
- Review
- 91 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K905070 (1991). 73 ancestors in all, the oldest K861692 (1986). No later device cites it as a predicate yet.
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 20 generations between
- 3 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- 1 generation backK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- This deviceK251971 RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS…Stryker Instruments · 2025
Show all 24 generations
- Root · 24 generations backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- 23 generations backK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- 22 generations backK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- 21 generations backK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- 20 generations backK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- 19 generations backK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- 18 generations backK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- 17 generations backK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
- 16 generations backK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled
- 15 generations backK121936 NaviopfsBlue Belt Technologies, Inc. · 2012 · Recalled
- 14 generations backK140596 NAVIOBlue Belt Technologies, Inc. · 2014
- 13 generations backK143668 NavioBlue Belt Technologies, Inc. · 2015
- 12 generations backK152574 NavioBlue Belt Technologies, Inc. · 2015
- 11 generations backK160537 NavioBlue Belt Technologies, Inc. · 2016
- 10 generations backK170360 NAVIOBlue Belt Technologies, Inc. · 2017
- 9 generations backK180271 NAVIO™ Surgical System (NAVIO system)Blue Belt Technologies, Inc. · 2018
- 8 generations backK191223 NAVIOBlue Belt Technologies, Inc. · 2019
- 7 generations backK193120 Real Intelligence CoriBlue Belt Technologies, Inc. · 2020
- 6 generations backK201022 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2020
- 5 generations backK212537 Real Intelligence Cori (Cori)Blue Belt Technologies, Inc. · 2021
- 4 generations backK220255 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 3 generations backK221224 Real Intelligence CoriBlue Belt Technologies, Inc. · 2022
- 2 generations backK231963 Real Intelligence™ Cori™Blue Belt Technologies, Inc. · 2023 · Recalled
- 1 generation backK240139 Real Intelligence™ CORI™Blue Belt Technologies, Inc. · 2024 · Recalled
- This deviceK251971 RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS…Stryker Instruments · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| −23 | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| −22 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −21 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| −20 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| −19 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| −18 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| −17 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
| −16 | K081867 | Mako Surgical Tactile Guidance System Version 2.0 | Mako Surgical Corp. | 2008 | 2 |
| −15 | K121936 | Naviopfs | Blue Belt Technologies, Inc. | 2012 | 2 |
| −14 | K140596 | NAVIO | Blue Belt Technologies, Inc. | 2014 | — |
| −13 | K143668 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −12 | K152574 | Navio | Blue Belt Technologies, Inc. | 2015 | — |
| −11 | K160537 | Navio | Blue Belt Technologies, Inc. | 2016 | — |
| −10 | K170360 | NAVIO | Blue Belt Technologies, Inc. | 2017 | — |
| −9 | K180271 | NAVIO™ Surgical System (NAVIO system) | Blue Belt Technologies, Inc. | 2018 | — |
| −8 | K191223 | NAVIO | Blue Belt Technologies, Inc. | 2019 | — |
| −7 | K193120 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2020 | — |
| −6 | K201022 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2020 | — |
| −5 | K212537 | Real Intelligence Cori (Cori) | Blue Belt Technologies, Inc. | 2021 | — |
| −4 | K220255 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −3 | K221224 | Real Intelligence Cori | Blue Belt Technologies, Inc. | 2022 | — |
| −2 | K231963 | Real Intelligence™ Cori™ | Blue Belt Technologies, Inc. | 2023 | 2 |
| −1 | K240139 | Real Intelligence™ CORI™ | Blue Belt Technologies, Inc. | 2024 | 1 |
| 0 (this device) | K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw… | Stryker Instruments | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 OLO? 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 OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 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 |
|---|---|---|---|
| * | K240139 | Real Intelligence™ CORI™Summary page 5…Class II Premarket Notification, 21 CFR 882.4560 Product Code OLO 807.92(a)(3) Legally marketed device(s) to which equivalence is claimed Predicate: Real K240139 Intelligence™ CORI™ Reference: Mako Total K241011 Knee Application Reference: Ortho K233542 Guidance Precision Kne… | 2024 |
| † | K241011 | Mako Total Knee Application | 2024 |
| † | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho… | 2024 |
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 34 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 15 of the 73 ancestors have a recall of any class.
- 2 other devices also cite its predicate K240139.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
The Stryker Robotic Precision System (RPS) Primary TKA Software application, when used with the Stryker Guidance Systems, is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to rigid anatomical structures during orthopedic procedures.
The RPS Primary TKA Software application is indicated for use in total knee arthroplasty (TKA) procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251971: RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251971
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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