Atlas FDA

LONG TROCHANTERIC NAIL SYSTEM

FDA 510(k) clearance K013563 · decided 2001-12-27

Clearance details

K-number
K013563
Device name
LONG TROCHANTERIC NAIL SYSTEM
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2001-10-26
Decision date
2001-12-27
Days to decision
62 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
ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM recall (Z-1225-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10M recall (Z-1226-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STE recall (Z-1227-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER TROC LAG SCR 70 MM The Trochanteric Nail System is inten recall (Z-1228-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System TROCH NAIL ST 11X180 125DG STRL TROCH NAIL ST 11X180 130DG ST recall (Z-1229-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER TROC NAIL 180X11X140 STER TROC NAIL 125 DEG X 11MM STER recall (Z-1230-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG ST recall (Z-1231-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER recall (Z-1232-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System ATN AR SCREW 60MM STERILE ATN AR SCREW 65MM STERILE ATN AR SC recall (Z-1233-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG recall (Z-1234-2018)Zimmer Biomet, Inc.2018-03-14
ACE Trochanteric Nail System STER L H TROC NAIL 320X9X125 STER L H TROC NAIL 340X9X125 STE recall (Z-1235-2018)Zimmer Biomet, Inc.2018-03-14
Depuy brand ACE trochanteric nail; sterile, long, left hip, 320 x 11 x 130; Product 925200 recall (Z-0390-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 9 x 130; Product 9252093 recall (Z-0391-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 9 x 130; Product 9252093 recall (Z-0392-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 9 x 130; Product 9252093 recall (Z-0393-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 9 x 130; Product 9252094 recall (Z-0394-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 11 x 130; Product 925211 recall (Z-0395-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 11 x 130; Product 925211 recall (Z-0396-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 11 x 130; Product 925211 recall (Z-0397-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 11 x 130; Product 925211 recall (Z-0398-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 11 x 130; Product 925211 recall (Z-0399-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 340 x 13 x 130; Product 925213 recall (Z-0400-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 360 x 13 x 130; Product 925213 recall (Z-0401-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 380 x 13 x 130; Product 925213 recall (Z-0402-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 400 x 13 x 130; Product 925213 recall (Z-0403-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, left hip, 420 x 13 x 130; Product 925213 recall (Z-0404-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 9 x 130; Product 926209 recall (Z-0405-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 9 x 130; Product 926209 recall (Z-0406-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 390 x 9 x 130; Product 926209 recall (Z-0407-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 9 x 130; Product 926209 recall (Z-0408-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 9 x 130; Product 926209 recall (Z-0409-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 320 x 11 x 130; Product 92621 recall (Z-0410-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 11 x 130; Product 92621 recall (Z-0411-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 11 x 130; Product 92621 recall (Z-0412-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 11 x 130; Product 92621 recall (Z-0413-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 11 x 130; Product 92621 recall (Z-0414-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 420 x 11 x 130; Product 92621 recall (Z-0415-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 340 x 13 x 130; Product 92621 recall (Z-0416-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 360 x 13 x 130; Product 92621 recall (Z-0417-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 380 x 13 x 130; Product 92621 recall (Z-0418-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, long, right hip, 400 x 13 x 130; Product 92621 recall (Z-0419-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 60 mm; Product 903211060. recall (Z-0450-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 65 mm; Product 903211065. recall (Z-0451-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 70 mm; Product 903211070. recall (Z-0452-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 75 mm; Product 903211075. recall (Z-0453-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 80 mm; Product 903211080. recall (Z-0454-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 85 mm; Product 903211085. recall (Z-0455-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 90 mm; Product 903211090. recall (Z-0456-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 95 mm; Product 903211095. recall (Z-0457-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; sterile, 100 mm; Product 903211100. recall (Z-0458-04)Depuy Orthopaedics, Inc.2004-01-31

PMA approvals by this applicant

RecordFirmDate
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
CERAMAX® ceramic total hip system (P070026/S120)DePuy Orthopaedics, Inc.2025-06-24
CERAMAX CERAMIC HIP SYSTEM (P070026/S119)DePuy Orthopaedics, Inc.2025-04-04
DePuy Ceramax Ceramic Total Hip System (P070026/S114)DePuy Orthopaedics, Inc.2025-03-19
Ceramax Ceramic Hip System (P070026/S117)DePuy Orthopaedics, Inc.2025-02-21
Ceramax® Ceramic Total Hip System (P070026/S116)DePuy Orthopaedics, Inc.2025-02-11