ITST Intertrochanteric/Subtrochanteric Fixation System— 510(k) K143321

Clearance details

Applicant

Zimmer, Inc.

Product code

Product code HSB

Device class

Class 2

Regulation

21 CFR 888.3020

Advisory panel

Orthopedic

Date received

2014-11-19

Decision date

2015-05-29

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-1681-2016 — ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745Class II·Terminated·Zimmer Manufacturing B.V.·20160504
• Z-1134-2016 — Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 225304045 INTERLOCKING IM SCREW 4.5 225304245 INTERLOCKING IM SCREW 4.5 225304545 INTERLOCKING IM SCREW 4.5 225305045 INTERLOCKING IM SCREW 4.5 225305245 INTERLOCKING IM SCREW 4.5 225305545 INTERLOCKING IM SCREW 4.5 225305745 INTERLOCKING IM SCREW 4.5 225306045 INTERLOCKING IM SCREW 4.5 225306545 INTERLOCKING IM SCREW 4.5 225307045 INTERLOCKING IM SCREW 4.5 Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.Class II·Terminated·Zimmer Manufacturing B.V.·20160111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143321.