OQGClass II

Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

21 CFR 888.3358 / Orthopedic

OQG is the FDA product code for Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, a class II device type, regulated under 21 CFR 888.3358. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 20 510(k) clearances under this code, the most recent dated 2021-08-20, and 2 recalls.

Classification record

Product code: OQG
Device name: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
FDA 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.
Regulation: 21 CFR 888.3358
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 20
Ingested recalls: 2

Clearances, product code OQG

By decision year

20 clearances under product code OQG with a decision year between 2011 and 2021, 2012 the highest year at 5.

Show the numbers

510(k) clearances under FDA product code OQG by decision year
Year	Clearances
2011	1
2012	5
2013	3
2014	3
2015	1
2017	3
2020	2
2021	2

Applicants with the most clearances

Product code OQG

Applicants holding the most 510(k) clearances under product code OQG
Applicant	Clearances
Encore Medical, LP	3
Kyocera Medical Technologies, Inc.	3
Renovis Surgical Technologies, LLC	3
Globus Medical, Inc.	2
Total Joint Orthopedics, Inc.	2
Aesculap Implant System, Inc.	1
Consensus Orthopedics, Inc.	1
Microport Orthopedics Inc.	1
Novosource, LLC	1
Pipeline Biomedical Products, LLC	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 93 companies shown, in name order