510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OQIClass II

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

21 CFR 888.3353 / Orthopedic
FDA source (opens on fda.gov)

OQI is the FDA product code for Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, a class II device type, regulated under 21 CFR 888.3353. 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 , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
OQI
Device name
Hip, Semi-Constrained, Cemented, Metal/Ceramic/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 888.3353
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
5
Ingested recalls
4

Clearances, product code OQI

By decision year
5 clearances under product code OQI with a decision year between 2012 and 2026, 2018 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OQI by decision year
YearClearances
20121
20182
20201
20261

Applicants with the most clearances

Product code OQI
Applicants holding the most 510(k) clearances under product code OQI
ApplicantClearances
Corin USA1
Exactech, Inc.1
implantcast GmbH1
Maxx Orthopedics Inc.1
United Orthopedic Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order