DeviceClearance

Product code OQG— Orthopedic

Renovis Surgical Hip Replacement System

Classification name
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
Device class
Class 2
Regulation
21 CFR 888.3358
Advisory panel
Orthopedic
Total cleared
20
First cleared
Most recent

FDA classification definition

“1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.”

— U.S. Food and Drug Administration, device classification record for product code OQG under 21 CFR 888.3358, via openFDA

Market context for product code OQG

FDA has cleared 20 devices under product code OQG between 2011 and 2021, filed by 14 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

Top applicants under product code OQG

Adverse events under product code OQG

product code OQG
Injury
249
Total
249

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 OQG

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