BIOMET CANNULATED SCREW SYSTEM— 510(k) K140891

Clearance details

Applicant

Biomet, Inc.

Product code

Code HWC

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2014-04-08

Decision date

2014-06-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K261057 — ActivaScrew Cannulated COM2026-09-04
• K260106 — OsteoCoil GT Active Compression System2026-08-24
• K262344 — Large Compression Screws2026-08-12
• K253858 — GFS - Sterile Screws and Top Hat2026-08-05
• K262075 — Lapidus Screw Kit2026-07-22

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K251270 — Taperloc® Complete Hip Stem2026-05-19
• K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
• K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Death

20

Injury

15,910

Malfunction

8,192

Other

1

Total

24,123

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-0617-2021 — 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.Class II·Terminated·Biomet, Inc.·20201125
• Z-0618-2021 — 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 110009934, 110009935, 110009936, 110009993, 110009994, 110009996, 110009998, 110010000, 110010003, 110010029, 110010030, 110010032, 110010099 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.Class II·Terminated·Biomet, Inc.·20201125
• Z-2303-2020 — Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.Class II·Terminated·Biomet·20200514
• Z-2304-2020 — Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.Class II·Terminated·Biomet·20200514
• Z-1064-2018 — 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.Class II·Terminated·Zimmer Biomet, Inc.·20171207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140891.