DeviceClearance

Product code KWL— Orthopedic

OsteoRemedies Hip Spacer System

Classification name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device class
Class 2
Regulation
21 CFR 888.3360
Advisory panel
Orthopedic
Total cleared
108
First cleared
Most recent

Market context for product code KWL

FDA has cleared 108 devices under product code KWL between 1979 and 2026, filed by 52 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 KWL

Adverse events under product code KWL

product code KWL
Injury
523
Total
523

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 KWL

1–100 of 108

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