OQG · Class II · 21 CFR 888.3358

FDA Product Code OQG: Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

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.

Leading manufacturers include Microport Orthopedics, Inc..

20
Total
20
Cleared
176d
Avg days
2011
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented Devices (Product Code OQG)

20 devices
1–20 of 20
Cleared Aug 20, 2021
Prime and DYNASTY® Additive Manufacturing Shells
K202705
Microport Orthopedics, Inc.
Orthopedic · 338d

About Product Code OQG - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code OQG since 2011, with 20 receiving FDA clearance (average review time: 176 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

OQG devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →