510(k) K100238 ยท HSB Rod, Fixation, Intramedullary And Accessories
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 11, 2010 |
| Received | Jan 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to s Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | None listed |
| Oct 2, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165
The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 280 mm, Item Number: 814309280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number: 814309180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number: 814309320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number: 814309360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number: 814309380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 420 mm, Item Number: 814309420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number: 814309440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number: 814309460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 125 11 mm x 180 mm, Item Number: 814311180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 280 mm, Item Number: 814311280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 300 mm, Item Number: 814311300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 320 mm, Item Number: 814311320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number: 814311340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number: 814311360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number: 814311380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 400 mm, Item Number: 814311400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number: 814311420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number: 814311440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number: 814311460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number: 814313180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number: 814313260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number: 814313280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number: 814313300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 320 mm, Item Number: 814313320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 340 mm, Item Number: 814313340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number: 814313360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number: 814313400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 420 mm,Item Number: 814313420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number: 814313440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 460 mm, Item Number: 814313460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number: 814409260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 280 mm, Item Number: 814409280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number: 814409300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number: 814409320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 340 mm, Item Number: 814409340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 360 mm, Item Number: 814409360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 380 mm, Item Number: 814409380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 400 mm, Item Number: 814409400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 420 mm, Item Number: 814409420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number: 814409440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number: 814409460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number: 814411260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number: 814411320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 340 mm, Item Number: 814411340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number: 814411360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 380 mm, Item Number: 814411380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 400 mm, Item Number: 814411400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 420 mm, Item Number: 814411420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 440 mm, Item Number: 814411440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 460 mm, Item Number: 814411460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number: 814413260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 280 mm, Item Number: 814413280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 300 mm, Item Number: 814413300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 320 mm, Item Number: 814413320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number: 814413340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number: 814413360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 380 mm, Item Number: 814413380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 400 mm, Item Number: 814413400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 420 mm, Item Number: 814413420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 460 mm, Item Number: 814413460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 9 mm x 180 mm, Item Number: 814509180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 260 mm, Item Number: 814509260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 280 mm, Item Number: 814509280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 300 mm, Item Number: 814509300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number: 814509320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 340 mm, Item Number: 814509340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 360 mm, Item Number: 814509360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 380 mm, Item Number: 814509380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 400 mm, Item Number: 814509400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 420 mm, Item Number: 814509420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 440 mm, Item Number: 814509440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 460 mm, Item Number: 814509460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number: 814511180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 260 mm, Item Number: 814511260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 280 mm, Item Number: 814511280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 300 mm, Item Number: 814511300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number: 814511320 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number: 814511340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number: 814511360 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 380 mm, Item Number: 814511380 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number: 814511400 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 420 mm, Item Number: 814511420 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 440 mm, Item Number: 814511440 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 11 mm x 460 mm, Item Number: 814511460 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 13 mm x 180 mm, Item Number: 814513180 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 13 mm x 260 mm, Item Number: 814513260 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 13 mm x 280 mm, Item Number: 814513280 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 13 mm x 300 mm, Item Number: 814513300 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 13 mm x 340 mm, Item Number: 814513340 Terminated |
HSB | None listed |
| Sep 13, 2018 | Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 13 mm x 380 mm, Item Number: 814513380 Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.