FDA product code OQI: Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
OQI is the FDA product code for hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel. FDA has cleared 5 510(k) submissions under OQI, 1 in the last five years, from 5 different applicants. The average 510(k) review took 253 days (median 263); 263 days on average over the last three years. FDA has posted 4 recalls for OQI devices, 4 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3353 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OQI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 189 |
| 2020 | 1 | 370 |
| 2026 | 1 | 263 |
Compare with all 510(k) review times · Search every OQI clearance
Top OQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Implantcast GmbH | 1 | 2026-04-24 |
| Maxx Orthopedics, Inc. | 1 | 2020-10-29 |
| United Orthopedic Corporation | 1 | 2018-06-12 |
| Exactech, Inc. | 1 | 2018-03-12 |
| Corin USA | 1 | 2012-02-06 |
Most recent OQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252451 | Implantcast GmbH | EPORE® XO cup system | 2026-04-24 | 263 |
| K192989 | Maxx Orthopedics, Inc. | Libertas E-XLPE Modular Liner | 2020-10-29 | 370 |
| K172833 | United Orthopedic Corporation | E-XPE Acetabular Components and U-Motion II Acetabular Cup | 2018-06-12 | 266 |
| K173583 | Exactech, Inc. | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | 2018-03-12 | 112 |
| K111481 | Corin USA | CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS | 2012-02-06 | 255 |
Recalls for OQI devices
4 product recalls in 3 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-12-31.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
Frequently asked questions
What is FDA product code OQI?
OQI is the FDA product code for hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented. It is a Class II device, regulated under 21 CFR 888.3353 and reviewed by the Orthopedic panel.
What device class is OQI?
Class II, regulation 21 CFR 888.3353. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQI?
Across 5 cleared submissions the average was 253 days from receipt to decision (median 263).
Which companies have the most OQI clearances?
Implantcast GmbH (1); Maxx Orthopedics, Inc. (1); United Orthopedic Corporation (1); Exactech, Inc. (1); Corin USA (1).
Have OQI devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2024-12-31.
Next steps
- Run an FDA pathway report with predicate devices for product code OQI
- Run a recall and safety report across every OQI manufacturer
- Watch product code OQI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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