DeviceClearance

Product code HWC— Orthopedic

BIOSCREW ABSORBABLE INTERFERENCE SCREW

Classification name
Screw, Fixation, Bone
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
1,064
First cleared
Most recent

Market context for product code HWC

FDA has cleared 1,064 devices under product code HWC between 1977 and 2026, filed by 379 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HWC

Adverse 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 →

Recent clearances under product code HWC

1–100 of 1,064

Data sourced from openFDA. This site is unofficial and independent of the FDA.