Product Code: OIY


Products Classified as OIY

4660Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + AdditiveKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4660Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + AdditiveKnee Joint Patellofemorotibial Polymer/metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [34059]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [38231]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [37410]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [37411]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [31877]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [33508]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [32210]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [33115]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [38290]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [37451]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [32380]21 CFR §888.3560 πŸ”Ž
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive [31849]21 CFR §888.3560 πŸ”Ž

Pre-market Notifications for OIY

K201347DePuy ATTUNEβ„’Β Total Knee SystemDePuy Orthopaedics, Inc.
K121727MOVATION KNEE SYSTEMENCORE MEDICAL, L.P.
K120038A200 KNEE SYSTEMRENOVIS SURGICAL TECHNOLOGIES, LLC
K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAENCORE MEDICAL, L.P.
K111433DEPUY STTUNE (TM) PS KNEE SYSTEMDEPUY ORTHOPAEDICS, INC.
K103756DEPUY ATTUNE TOTAL KNEE SYSTEMDEPUY ORTHOPAEDICS, INC.
K103223HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTSENCORE MEDICAL, L.P.
K101433DEPUY ATTUNE KNEE SYSTEMDEPUY ORTHOPAEDICS, INC.
K100048E1 ANTIOXIDANT INFUSED TECHNOLOGYBIOMET MANUFACTURING CORP.
K091956HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712ENCORE MEDICAL, L.P.

Global Unique Device Identification Database

00190446269977Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269960Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269946Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269939Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269922Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269892Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269885Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269878Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269847Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269823Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269816Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269793Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269779Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269762Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive
00190446269755Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Maude Adverse Events

PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2020-03-31
3D KNEEENCORE MEDICAL L.P.2020-03-25
3D KNEEENCORE MEDICAL L.P.2020-03-20
3D KNEEENCORE MEDICAL L.P.2020-03-20
PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS)ZIMMER ORTHOPAEDIC MFG. LTD.2020-03-12
PERSONA TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2020-03-12
PERSONA CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2020-03-05
3D KNEEENCORE MEDICAL L.P.2020-03-03
ARTICULAR SURFACE FIXED BEARING ULTRACONGRUENT (UC) LEFT 12 MM HEIGHTZIMMER ORTHOPAEDIC MFG. LTD.2020-03-02
VANGUARD PS OPEN INTL FEMORAL RIGHTZIMMER BIOMET, INC.2020-02-21
3D KNEEENCORE MEDICAL L.P.2020-02-20
VANGUARD ANTERIOR STABILIZED BEARINGZIMMER BIOMET, INC.2020-02-18
VANGUARD CR ILOK FEMORAL RIGHTZIMMER BIOMET, INC.2020-02-18
3D KNEEENCORE MEDICAL L.P.2020-02-12
BIOMET FINNED PRI STEMZIMMER BIOMET, INC.2020-02-06
E-POLY 40MM +3 HIWALL LNR SZ24ZIMMER BIOMET, INC.2020-02-03
PERSONA STEMMED TIBIAZIMMER ORTHOPAEDIC MFG. LTD.2020-01-29
EPOLY 36MM +5 RGLC LNR HW SZ23 Z23ZIMMER BIOMET, INC.2020-01-27
VEGA SYSTEM KNEE REPLACEMENT, TIBIAL COMPONENTAESCULAP2020-01-22
EPOLY RLC 36MM 10DEG SZ24ZIMMER BIOMET, INC.2020-01-20
E-POLY 40MM +3 MAXROM LNR SZ24ZIMMER BIOMET, INC.2020-01-20
HIGHLY CROSS-LINKED KNEEENCORE MEDICAL L.P.2020-01-16
3D KNEEENCORE MEDICAL L.P.2020-01-13
ATTUNE CR FB INSRT SZ 9 5MMDEPUY IRELAND - 96166712020-01-10
MOVATION KNEEENCORE MEDICAL L.P.2020-01-03
3D KNEEENCORE MEDICAL L.P.2019-11-20
E-POLY 40MM +3 HIWALL LNR SZ25ZIMMER BIOMET, INC.2019-11-14
E-POLY 40MM +3 HIWALL LNRZIMMER BIOMET, INC.2019-11-12
E-POLY 38MM +5HW LNRZIMMER BIOMET, INC.2019-11-12
MOVATION KNEE SYSTEMENCORE MEDICAL L.P.2019-10-30
E1 RINGLOC ACETABULAR LINERZIMMER BIOMET, INC.2019-10-28
MOVATION 3D KNEEENCORE MEDICAL L.P.2019-10-23
ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZEDZIMMER ORTHOPAEDIC MFG. LTD.2019-10-23
3D KNEEENCORE MEDICAL L.P.2019-10-18
MOVATION KNEEENCORE MEDICAL L.P.2019-10-17
PSN CONST TASP SHIM GH 12MMZIMMER BIOMET, INC.2019-10-03
ARTICULAR SURFACE MEDIAL CONGRUENT (MC) RIGHT 10 MM HEIGHTZIMMER BIOMET, INC.2019-09-30
3D KNEEENCORE MEDICAL L.P.2019-09-27
PERSONA VE ALL POLY PATELLAZIMMER BIOMET, INC.2019-09-19
3D KNEEENCORE MEDICAL L.P.2019-09-18
UNKNOWN PERSONA BEARINGZIMMER BIOMET, INC.2019-09-16
VIVACIT-E ART SURF SZ 3 8MMSMITH & NEPHEW, INC.2019-09-13
PERSONA? VIVACIT-E?ZIMMER ORTHOPAEDIC MFG. LTD.2019-09-12
VANGUARD CR ILOK FEM-LT 72.5ZIMMER BIOMET, INC.2019-09-10
PERSONA PS ARTICULAR SURFACEZIMMER ORTHOPAEDIC MFG. LTD.2019-09-06
3D KNEEENCORE MEDICAL L.P.2019-09-04
3D KNEEENCORE MEDICAL L.P.2019-09-04
3D KNEEENCORE MEDICAL L.P.2019-09-03
ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED (PS) RIGHT 10 MM HEIGHTZIMMER ORTHOPAEDIC MFG. LTD.2019-08-28
PERSONA MC TIBIAL ARTICULAR SURFACE PROVISIONALZIMMER BIOMET, INC.2019-08-26

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