INTRAMEDULLARY NAIL SYSTEM— 510(k) K965098

Clearance details

Applicant

Zimmer, Inc.

Product code

Code HSB

Device class

Class 2

Regulation

21 CFR 888.3020

Advisory panel

Orthopedic

Date received

1996-12-20

Decision date

1997-02-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K253155 — Fule Metallic Lockable Intramedullary Nail Systems2026-06-17
• K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16

• K260831 — Z1 Hip System2026-06-16
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)2026-04-13

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-2596-2017 — FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM FEM IM NAIL 15MMDX34CM FEM IM NAIL 16MMDX34CM FEM IM NAIL 14MMDX36CM FEM IM NAIL 15MMDX36CM FEM IM NAIL 14MMDX38CM FEM IM NAIL 15MMDX38CM FEM IM NAIL 11MMDX40CM FEM IM NAIL 13MMDX40CM FEM IM NAIL 14MMDX40CM FEM IM NAIL 15MMDX40CM FEM IM NAIL 11MMDX42CM FEM IM NAIL 12MMDX42CM FEM IM NAIL 13MMDX42CM FEM IM NAIL 14MMDX42CM FEM IM NAIL 15MMDX42CM FEM IM NAIL 11MMDX44CM FEM IM NAIL 12MMDX44CM FEM IM NAIL 13MMDX44CM FEM IM NAIL 14MMDX44CM FEM IM NAIL 10MMDX46CM FEM IM NAIL 11MMDX46CM FEM IM NAIL 12MMDX46CM FEM IM NAIL 13MMDX46CM FEM IM NAIL 14MMDX46CM FEM IM NAIL 10MMDX48CM FEM IM NAIL 11MMDX48CM FEM IM NAIL 12MMDX48CM FEM IM NAIL 13MMDX48CM FEM IM NAIL 14MMDX48CM FEM IM NAIL 13MMDX50CM FEM IM NAIL 14MMDX50CMClass II·Terminated·Zimmer Biomet, Inc.·20170428
• Z-2597-2017 — TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIBIAL I/M NAIL 14MMDX34CM TIBIAL I/M NAIL 15MMDX34CM TIBIAL I/M NAIL 14MMDX36CM TIBIAL I/M NAIL 15MMDX36CM TIBIAL I/M NAIL 14MMDX38CM TIBIAL I/M NAIL 15MMDX38CM TIBIAL I/M NAIL 13MMDX40CM TIBIAL I/M NAIL 14MMDX40CM TIBIAL I/M NAIL 15MMDX40CM TIBIAL I/M NAIL 13MMDX42CM TIBIAL I/M NAIL 14MMDX42CM TIBIAL I/M NAIL 15MMDX42CM TIBIAL I/M NAIL 11MMDX44CM TIBIAL I/M NAIL 13MMDX44CM TIBIAL I/M NAIL 14MMDX44CM TIBIAL I/M NAIL 11MMDX46CM TIBIAL I/M NAIL 12MMDX46CM TIBIAL I/M NAIL 13MMDX46CMClass II·Terminated·Zimmer Biomet, Inc.·20170428
• Z-2549-2017 — Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2550-2017 — Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2551-2017 — Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2552-2017 — Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2553-2017 — Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2554-2017 — Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2555-2017 — Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2556-2017 — Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2557-2017 — Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2558-2017 — Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2559-2017 — Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2560-2017 — Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2561-2017 — Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2567-2017 — Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2568-2017 — Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2569-2017 — Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2570-2017 — Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228
• Z-2571-2017 — Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail ImplantsClass II·Terminated·Zimmer Biomet, Inc.·20170228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K965098.