Biomet Headless Compression and Twist-off Screws— 510(k) K142658

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code HWC

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2014-09-18

Decision date

2014-11-13

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

• K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
• K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
• K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
• K202232 — Comprehensive Vault Reconstruction System2021-02-19
• K193038 — Comprehensive Shoulder System2020-10-28

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-1302-2019 — T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.Class II·Terminated·Zimmer Biomet, Inc.·20190328
• Z-1303-2019 — T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.Class II·Terminated·Zimmer Biomet, Inc.·20190328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142658.