Atlas FDA

TROCHANTERIC NAIL

FDA 510(k) clearance K010780 · decided 2001-06-12

Clearance details

K-number
K010780
Device name
TROCHANTERIC NAIL
Applicant
DePuy Orthopaedics, Inc.
Decision
Substantially Equivalent
Date received
2001-03-15
Decision date
2001-06-12
Days to decision
89 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, short 125 deg x 9 mm; Product 903209125. recall (Z-0420-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short 130 deg x 9 mm; Product 903209130. recall (Z-0421-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 135 deg x 9 mm; Product 903209135. recall (Z-0422-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 140 deg x 9 mm; Product 903209140. recall (Z-0423-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 125; Product 903211125. recall (Z-0424-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 130; Product 903211130. recall (Z-0425-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 135; Product 903211135. recall (Z-0426-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 11 mm; Product 903211225. recall (Z-0427-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 11 mm; Product 903211230. recall (Z-0428-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 11 mm; Product 903211235. recall (Z-0429-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, stnadard, 140 deg x 11 mm; Product 903211240. recall (Z-0430-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 125; Product 903213125. recall (Z-0431-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 130; Product 903213130. recall (Z-0432-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 135; Product 903213135. recall (Z-0433-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 13 mm; Product 903213225. recall (Z-0434-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 13 mm; Product 903213230. recall (Z-0435-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 13 mm; Product 903213235. recall (Z-0436-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; sterile, standard, 140 deg x 13 mm; Product 903213240. recall (Z-0437-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, short, 125D 9 x 180 mm; Product 903009125. recall (Z-0438-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, short, 130D 9 x 180 mm; Product 903009130. recall (Z-0439-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, short, 135D 9 x 180 mm; Product 903009135. recall (Z-0440-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, short, 140D 9 x 180 mm; Product 903009140. recall (Z-0441-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 11 x 200 mm; Product 903011 recall (Z-0442-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 11 x 200 mm; Product 903011 recall (Z-0443-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 11 x 200 mm; Product 903011 recall (Z-0444-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 11 x 200 mm; Product 903011 recall (Z-0445-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 13 x 200 mm; Product 903013 recall (Z-0446-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 13 x 200 mm; Product 903013 recall (Z-0447-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 13 x 200 mm; Product 903013 recall (Z-0448-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 13 x 200 mm; Product 903013 recall (Z-0449-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5mm x 60 mm; Product 90301106 recall (Z-0463-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 65 mm; Product 9030110 recall (Z-0464-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 70 mm; Product 9030110 recall (Z-0465-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 75 mm; Product 9030110 recall (Z-0466-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 80 mm; Product 9030110 recall (Z-0467-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 85 mm; Product 9030110 recall (Z-0468-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 90 mm; Product 9030110 recall (Z-0469-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 95 mm; Product 9030110 recall (Z-0470-04)Depuy Orthopaedics, Inc.2004-01-31
Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 100 mm; Product 903011 recall (Z-0471-04)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