Manufacturer
Enztec LimitedRI.KNEE Adjustable Tibia Cut Guide
Country / Region:New Zealand (NZ)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
- K230876
- Device name
- RI.KNEE Adjustable Tibia Cut Guide
- Company
- Enztec Limited
- Country / Region
- New Zealand(NZ)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2023-03-30
- Decision date
- 2023-06-27
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Knee SurgeryRobotic Assistance
- Primary application
- Knee Surgery
- Classification source
- AI classified
Indications for Use
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
Intended Use
The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.
Device Description
The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.
Summary parsed at:2026-06-19 05:45:48 UTC
Predicate devices
1REAL INTELLIGENCE CORI
K230876 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K230876 as a predicate