HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM— 510(k) K100238

Clearance details

Applicant

DePuy Orthopaedics, Inc.

Product code

Code HSB

Device class

Class 2

Regulation

21 CFR 888.3020

Advisory panel

Orthopedic

Date received

2010-01-27

Decision date

2010-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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Death

49

Injury

12,083

Malfunction

6,561

Other

1

Total

18,694

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0447-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0448-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0449-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0450-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0451-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0452-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0453-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0454-2019 — 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 stabilize fractures of the proximal femur.Class II·Terminated·Zimmer Biomet, Inc.·20181002
• Z-0122-2019 — Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0123-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 260 mm, Item Number 814309260 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0124-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0125-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0126-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 340 mm, Item Number 814309340 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0128-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number 814309380 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0129-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0130-2019 — Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0131-2019 — Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0132-2019 — Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number 814311340 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0133-2019 — Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number 814311360 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808
• Z-0134-2019 — Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fracturesClass II·Terminated·Zimmer Biomet, Inc.·20180808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100238.