FDA Product Code MAY

Product Code: MAY

Products Classified as MAY

4613

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4613

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish

Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [34059]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [38231]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [34070]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [37410]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [37411]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [33508]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [32210]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [38290]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [32380]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [33509]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [33949]	21 CFR §888.3353 🔎
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish [32381]	21 CFR §888.3353 🔎

Pre-market Notifications for MAY

K123604	ABG III MONOLITHIC HIP STEM	HOWMEDICA OSTEONICS CORP
K110807	ABG II MONOLITHIC HIP STEM	STRYKER CORP.
K090103	100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL	BIOMET, INC.
K051844	EQUATOR PLUS ACETABULAR CUP SYSTEM	PORTLAND ORTHOPAEDICS PTY. LTD.

Global Unique Device Identification Database

00880304926943	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675995	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675964	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675933	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675902	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675650	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675643	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675612	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675599	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304675544	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304673694	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304649071	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304649057	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304647749	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
00880304647732	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Maude Adverse Events

E-POLY 40MM +3 HIWALL LNR SZ24	ZIMMER BIOMET, INC.	2020-03-20
DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE	DEPUY ORTHOPAEDICS, INC.	2020-02-04
DEPUY PINNACLE METAL ON CERAMIC HIP DEVICE	DEPUY ORTHOPAEDICS, INC.	2020-02-04
TAPERLOC 133 T1 PPS SO 16X152MM T1	ZIMMER BIOMET, INC.	2020-01-10
TAPERLOC 133 T1 PPS SO 14X148MM T1	ZIMMER BIOMET, INC.	2020-01-10
TAPERLOC 133 T1 PPS HO 11X142MM 2MM T1	ZIMMER BIOMET, INC.	2020-01-10
TPRLC 133 T1 PPS HO 16X152MM 2MM T1	ZIMMER BIOMET, INC.	2020-01-09
TPRLC 133 T1 PPS HO 15X150MM 0MM T1	ZIMMER BIOMET, INC.	2019-12-19
TPRLC 133 T1 PPS HO 16X152MM 2MM T1	ZIMMER BIOMET, INC.	2019-12-19
E-POLY 36MM +3 HIWALL LNR SZ23	ZIMMER BIOMET, INC.	2019-08-19
E-POLY 36MM +3 MAXROM LNR SZ23	ZIMMER BIOMET, INC.	2019-06-10
IM REAMER, MOD. TRINKLE FITTING BIXCUT ?10,5X480MM	STRYKER TRAUMA KIEL	2019-02-21
BIOLOX DELTA CERAMIC HEADS 36MM	BIOMET, INC.	2019-01-25
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2019-01-21
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2019-01-21
E-POLY 36MM +3 HIWALL LNR SZ23	ZIMMER BIOMET, INC.	2018-10-29
E-POLY 36MM +3 HIWALL LINER SZ23	ZIMMER BIOMET, INC.	2018-10-24
E-POLY HIWALL LINER	ZIMMER BIOMET, INC.	2018-10-24
E-POLY 32MM +3 HIWALL LNR SZ22	ZIMMER BIOMET, INC.	2018-10-04
E-POLY 36MM +3 HIWALL LNR SZ23	ZIMMER BIOMET, INC.	2018-09-26
E-POLY 36MM +3 MAXROM LNR SZ23	ZIMMER BIOMET, INC.	2018-08-21
E-POLY 32MM +3 MAXROM LNR	ZIMMER BIOMET, INC.	2018-08-09
E-POLY 40MM +3 MAXROM LNR SZ25	ZIMMER BIOMET, INC.	2018-08-08
E-POLY 40MM +3 MAXROM LNR SZ25	ZIMMER BIOMET, INC.	2018-08-07
E-POLY 36MM +3 MAXROM LINER SZ23	ZIMMER BIOMET, INC.	2018-08-07
E-POLY 36MM +3 HIWALL LNR SZ23	ZIMMER BIOMET, INC.	2018-06-21
E-POLY 32MM +3 MAXROM LNR SZ22	ZIMMER BIOMET, INC.	2018-06-12
RINGLOC HIP SYSTEM ACETABULAR LINER	ZIMMER BIOMET, INC.	2018-06-12
E-POLY 36MM +3 MAXROM LINER SZ23	ZIMMER BIOMET, INC.	2018-05-01
E-POLY 40MM +3 HIWALL LNR SZ24	ZIMMER BIOMET, INC.	2018-04-27
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-04-25
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-04-11
E-POLY 40MM +3 HIWALL LNR SZ24	ZIMMER BIOMET, INC.	2018-04-10
E-POLY 40MM +3 HIWALL LNR SZ24	ZIMMER BIOMET, INC.	2018-04-10
BIOMET E-POLY LINER	ZIMMER BIOMET, INC.	2018-03-19
E-POLY 40MM +3 MAXROM LNR SZ24	ZIMMER BIOMET, INC.	2018-03-14
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-03-06
CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM	STELKAST INC.	2018-03-06
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-03-06
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-03-01
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-03-01
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-02-15
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-02-15
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2018-02-14
CROSS-OVER ACETABULAR SHELL AND LINER SYSTEM	STELKAST INC.	2018-02-14
BIOMET E1 POLY LINER	ZIMMER BIOMET, INC.	2018-02-07
GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA ?3X800 MM	STRYKER TRAUMA KIEL	2018-01-10
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2017-12-12
IM REAMER, MOD. TRINKLE FITTING BIXCUT ?10,0X480MM	STRYKER TRAUMA KIEL	2017-11-17
EXP ACETABULAR SHELL AND LINER	STELKAST INC.	2017-11-16