ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM— 510(k) K121771
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K121771 for ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM, Substantially Equivalent on 2012-11-07. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- 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
- Warsaw, IN, US
Recent devices under product code MBH
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view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K253566 — Affixus Retrograde Femoral Nailing 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 →
Recalls naming K121771
K-number listed on FDA's recall record- Z-1917-2016 — Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
- Z-1266-2015 — Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121771.
Data sourced from openFDA. This site is unofficial and independent of the FDA.