Atlas FDA

HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM

FDA 510(k) clearance K100238 · decided 2010-05-11

Clearance details

K-number
K100238
Device name
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2010-01-27
Decision date
2010-05-11
Days to decision
104 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Affixus Hip Fracture Nail Right 125 9 mm x 280 mm, Item Number: 814309280 recall (Z-3046-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number: 814309180 recall (Z-3047-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 recall (Z-3048-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number: 814309320 recall (Z-3049-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number: 814309360 recall (Z-3050-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number: 814309380 recall (Z-3051-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 420 mm, Item Number: 814309420 recall (Z-3052-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number: 814309440 recall (Z-3053-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number: 814309460 recall (Z-3054-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail 125 11 mm x 180 mm, Item Number: 814311180 recall (Z-3055-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 280 mm, Item Number: 814311280 recall (Z-3056-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 300 mm, Item Number: 814311300 recall (Z-3057-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 320 mm, Item Number: 814311320 recall (Z-3058-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number: 814311340 recall (Z-3059-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number: 814311360 recall (Z-3060-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number: 814311380 recall (Z-3061-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 400 mm, Item Number: 814311400 recall (Z-3062-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number: 814311420 recall (Z-3063-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number: 814311440 recall (Z-3064-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number: 814311460 recall (Z-3065-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number: 814313180 recall (Z-3066-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number: 814313260 recall (Z-3067-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number: 814313280 recall (Z-3068-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number: 814313300 recall (Z-3069-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 320 mm, Item Number: 814313320 recall (Z-3070-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 340 mm, Item Number: 814313340 recall (Z-3071-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number: 814313360 recall (Z-3072-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380 recall (Z-3073-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number: 814313400 recall (Z-3074-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 420 mm,Item Number: 814313420 recall (Z-3075-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number: 814313440 recall (Z-3076-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Right 125 13 mm x 460 mm, Item Number: 814313460 recall (Z-3077-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number: 814409260 recall (Z-3078-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 280 mm, Item Number: 814409280 recall (Z-3079-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number: 814409300 recall (Z-3080-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number: 814409320 recall (Z-3081-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 340 mm, Item Number: 814409340 recall (Z-3082-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 360 mm, Item Number: 814409360 recall (Z-3083-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 380 mm, Item Number: 814409380 recall (Z-3084-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 400 mm, Item Number: 814409400 recall (Z-3085-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 420 mm, Item Number: 814409420 recall (Z-3086-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number: 814409440 recall (Z-3087-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number: 814409460 recall (Z-3088-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number: 814411260 recall (Z-3089-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number: 814411320 recall (Z-3090-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 340 mm, Item Number: 814411340 recall (Z-3091-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number: 814411360 recall (Z-3092-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 380 mm, Item Number: 814411380 recall (Z-3093-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 400 mm, Item Number: 814411400 recall (Z-3094-2018)Zimmer Biomet, Inc.2018-09-13
Affixus Hip Fracture Nail Left 125 11 mm x 420 mm, Item Number: 814411420 recall (Z-3095-2018)Zimmer Biomet, Inc.2018-09-13

PMA approvals by this applicant

RecordFirmDate
CERAMAX® Ceramic Total Hip System (P070026/S128)DePuy Orthopaedics, Inc.2026-07-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S127)DePuy Orthopaedics, Inc.2026-06-03
Ceramax® Ceramic Hip System (P070026/S125)DePuy Orthopaedics, Inc.2026-04-29
Ceramax Ceramic Hip System (P070026/S124)DePuy Orthopaedics, Inc.2026-04-10
Ceramax® Ceramic Total Hip System (P070026/S118)DePuy Orthopaedics, Inc.2026-01-08
Ceramax Ceramic Hip System (P070026/S123)DePuy Orthopaedics, Inc.2025-12-09
CERAMAX CERAMIC HIP SYSTEM (P070026/S121)DePuy Orthopaedics, Inc.2025-08-05
CERAMAX CERAMIC HIP SYSTEM (P070026/S122)DePuy Orthopaedics, Inc.2025-08-01