Manufacturer
Stryker InstrumentsRPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251971
- Device name
- RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer
- Company
- Stryker Instruments
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-06-26
- Decision date
- 2025-09-25
- Submission type
- Traditional
- Technology type
- Software Navigation(AI inferred)
- Clinical applications
- Knee SurgeryNavigation System
- Primary application
- Knee Surgery
- Classification source
- AI classified
Indications for Use
RPS is intended to be used by trained medical professionals in an operating room setting of a hospital or ambulatory surgery center. CORI is intended to be used by trained medical professionals in a hospital or clinical setting equivalent to an orthopedic surgery suite. Compatible Implants include Triathlon CR/PS Total Knee Implants, cemented and cementless (Complete Workflow), Implants with implant-specific cut guide requiring primary distal femoral and proximal tibial cuts (Quick-Cut Workflow), and Smith+Nephew knee implants as defined in product labeling, cemented and cementless models.
Intended Use
The Stryker Robotic Power 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.
Device Description
RPS is a total joint bone preparation system to support total knee arthroplasty (TKA) consisting of functionality for intraoperative planning, kinematic analysis, boundary control, and guided resection. The Complete Workflow allows for the placement of Stryker Triathlon CR/PS Total Knee Implants (cemented or cementless), and plans/resects all 6 primary femoral/tibial resections. The Quick-Cut Workflow allows for placement of implants with implant-specific cut guides requiring primary distal femoral and proximal tibial cuts. A handheld robotic saw is guided via camera visualization in relation to patient anatomy and the surgical plan established intraoperatively. The robotic saw movement is partially controlled by the RPS Console which determines, based on surgical plan and localization data, how the saw actuators need to move within three degrees of freedom (elevation, pitch, roll) to maintain the planned cut plane. The surgeon controls the remaining degrees of freedom.
Summary parsed at:2026-06-19 05:16:39 UTC
Predicate devices
3Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
Real Intelligence™ CORI™
Mako Total Knee Application
K251971 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251971 as a predicate
