WIRE & STEINMAN PINS— 510(k) K831005

Clearance details

Applicant

Kirschner Medical Corp.

Product code

Code HTY

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

1983-03-30

Decision date

1983-05-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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Injury

544

Total

544

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-2230-2018 — DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2231-2018 — DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2232-2018 — BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2233-2018 — BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2234-2018 — GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2235-2018 — BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2236-2018 — G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2237-2018 — G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2238-2018 — G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2239-2018 — BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2240-2018 — 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2241-2018 — RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-2242-2018 — 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.Class II·Terminated·Zimmer Biomet, Inc.·20180516
• Z-0087-2017 — Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture has been reduced.Class II·Terminated·Zimmer Biomet, Inc.·20160802
• Z-1822-2016 — Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.Class II·Terminated·Biomet, Inc.·20160401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K831005.