ARTHROTEK INTERFERENCE SCREW— 510(k) K934469
Substantially Equivalent for Some IndicationsBiomet, Inc.
FDA 510(k) clearance K934469 for ARTHROTEK INTERFERENCE SCREW, Substantially Equivalent for Some Indications on 1994-02-23. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code HWC
view allMore clearances from Biomet, Inc.
view allAdverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K934469
K-number listed on FDA's recall record- Z-0630-2021 — Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
- Z-0753-2013 — TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934469.
Data sourced from openFDA. This site is unofficial and independent of the FDA.