Unity Total Knee System, Unity Knee Cementless CR Femur— 510(k) K261275
Substantially EquivalentCorin, Ltd.
FDA 510(k) clearance K261275 for Unity Total Knee System, Unity Knee Cementless CR Femur, Substantially Equivalent on 2026-09-17. Applicant: Corin, Ltd.. Device class: 2.
Summary
Corin, Ltd. filed the Unity Total Knee System, Unity Knee Cementless CR Femur, under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer). The record gives no sizes or other components.
Class II, 21 CFR 888.3565. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.
Corin filed from Cirencester, United Kingdom. The decision came 153 calendar days after receipt (April 17 to September 17, 2026).
Clearance details
- Applicant
- Corin, Ltd.
- Product code
- Product code MBH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3565
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cirencester, GB
Recent devices under product code MBH
view allMore clearances from Corin, Ltd.
view all- K261576 — Icona Hip Stem
- K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
- K200888 — OMNIBotics Knee System
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.