510(k) K010780 ยท HSB Rod, Fixation, Intramedullary And Accessories
TROCHANTERIC NAIL
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 12, 2001 |
| Received | Mar 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
ACE TROCH NAIL 125 DEG. X 11MM
ACE TROCH NAIL 130 DEG. X 11MM
ACE TROCH NAIL 135 DEG. X 11MM
ACE TROCH NAIL 125 DEG. X 13MM
ACE TROCH NAIL 130 DEG. X 13MM
ACE TROCH NAIL 1 Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER TROC END CAP
STER TROC END CAP 5MM
STER TROC END CAP 10MM
STER TROC END CAP 15MM
STER TROC END CAP 20MM
STER TROC END CAP 25MM
The Trochanteric Nail System is intend Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER TROC NAIL 125 DEG X 9MM
STER TROC NAIL 130 DEG X 9MM
STER TROC NAIL 135 DEG X 9MM
The Trochanteric Nail System is intended to treat stable and unstable proximal frac Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER TROC LAG SCR 70 MM
The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertr Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
TROCH NAIL ST 11X180 125DG STRL
TROCH NAIL ST 11X180 130DG STRL
TROCH NAIL ST 11X180 135DG STRL
The Trochanteric Nail System is intended to treat stable and unstable prox Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER TROC NAIL 180X11X140
STER TROC NAIL 125 DEG X 11MM
STER TROC NAIL 130 DEG X 11MM
STER TROC NAIL 135 DEG X 11MM
The Trochanteric Nail System is intended to treat stab Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
TROCH NAIL ST 13X180 125DG STRL
TROCH NAIL ST 13X180 130DG STRL
TROCH NAIL ST 13X180 135DG STRL
The Trochanteric Nail System is intended to treat stable and unstable prox Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER TROC NAIL 180X13X140
STER TROC NAIL 125 DEG X 13MM
STER TROC NAIL 130 DEG X 13MM
STER TROC NAIL 135 DEG X 13MM
The Trochanteric Nail System is intended to treat st Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
ATN AR SCREW 60MM STERILE
ATN AR SCREW 65MM STERILE
ATN AR SCREW 70MM STERILE
ATN AR SCREW 75MM STERILE
ATN AR SCREW 80MM STERILE
ATN AR SCREW 85MM STERILE
ATN AR SCREW 90 Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
ATN LAG SCREW 60MM STERILE
ATN LAG SCREW 65MM STERILE
ATN LAG SCREW 70MM STERILE
ATN LAG SCREW 75MM STERILE
ATN LAG SCREW 80MM STERILE
ATN LAG SCREW 85MM STERILE
ATN LAG S Terminated |
HSB | None listed |
| Mar 14, 2018 | Zimmer Biomet, Inc. ACE Trochanteric Nail System
STER L H TROC NAIL 320X9X125
STER L H TROC NAIL 340X9X125
STER L H TROC NAIL 360X9X125
STER L H TROC NAIL 380X9X125
STER L H TROC NAIL 400X9X125
STER L H TROC NAIL 420X9X1 Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short 125 deg x 9 mm; Product 903209125. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short 130 deg x 9 mm; Product 903209130. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 135 deg x 9 mm; Product 903209135. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 140 deg x 9 mm; Product 903209140. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 125; Product 903211125. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 130; Product 903211130. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 11 x 135; Product 903211135. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 11 mm; Product 903211225. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 11 mm; Product 903211230. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 11 mm; Product 903211235. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, stnadard, 140 deg x 11 mm; Product 903211240. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 125; Product 903213125. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 130; Product 903213130. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, short, 180 x 13 x 135; Product 903213135. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 125 deg x 13 mm; Product 903213225. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 130 deg x 13 mm; Product 903213230. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 135 deg x 13 mm; Product 903213235. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; sterile, standard, 140 deg x 13 mm; Product 903213240. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, short, 125D 9 x 180 mm; Product 903009125. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, short, 130D 9 x 180 mm; Product 903009130. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, short, 135D 9 x 180 mm; Product 903009135. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, short, 140D 9 x 180 mm; Product 903009140. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 11 x 200 mm; Product 903011225. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 11 x 200 mm; Product 903011230. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 11 x 200 mm; Product 903011235. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 11 x 200 mm; Product 903011240. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 125D 13 x 200 mm; Product 903013225. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 130D 13 x 200 mm; Product 903013230. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 135D 13 x 200 mm; Product 903013235. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail; non-sterile, standard, 140D 13 x 200 mm; Product 903013240. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5mm x 60 mm; Product 903011060. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 65 mm; Product 903011065. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 70 mm; Product 903011070. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 75 mm; Product 903011075. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 80 mm; Product 903011080. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 85 mm; Product 903011085. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 90 mm; Product 903011090. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 95 mm; Product 903011095. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 100 mm; Product 903011100. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 105 mm; Product 903011105. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 110 mm; Product 903011110. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 115 mm; Product 903011115. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail lag screw; non-sterile, 10.5 mm x 120 mm; Product 903011120. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 60 mm; Product 903205060. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 65 mm; Product 903205065. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 70 mm; Product 903205070. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation superior screw; sterile, 75 mm; Product 903205075. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 80 mm; Product 903205080. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 85 mm; Product 903205085. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 90 mm; Product 903205090. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 95 mm; Product 903205095. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; sterile, 100 mm; Product 903205100. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 60 mm; Product 903005060. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 65 mm; Product 903005065. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 70 mm; Product 903005070. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 75 mm; Product 903005075. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 80 mm; Product 903005080. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 85 mm; Product 903005085. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 90 mm; Product 903005090. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 95 mm; Product 903005095. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail anti-rotation/ superior screw; non-sterile, 5 mm x 100 mm; Product 903005100. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile; Product 903208000. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile, 5 mm; Product 903208005. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile, 10 mm; Product 903208010. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile, 15 mm; Product 903208015. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile, 20 mm; Product 903208020. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, sterile, 25 mm; Product 903208025. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 0 mm; Product 903008000. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 5 mm; Product 903208005. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 10 mm; Product 903008010. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 15 mm; Product 903008015. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 20 mm; Product 903008020. Terminated |
HSB | None listed |
| Jan 31, 2004 | Depuy Orthopaedics, Inc. Depuy brand ACE trochanteric nail end cap, non-sterile, 25 mm; Product 903008025. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.