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..

1
Total
1
Cleared
338d
Avg days
2021
Since

List of Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented devices cleared through 510(k)

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

How to use this database

This page lists all FDA 510(k) submissions for Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented devices (product code OQG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →