FDA product code OQG: Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQG is the FDA product code for hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel. FDA has cleared 20 510(k) submissions under OQG, from 14 different applicants. The average 510(k) review took 176 days (median 142). FDA has posted 2 recalls for OQG devices, 1 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 Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class II |
| Regulation | 21 CFR 888.3358 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OQG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 100 |
| 2020 | 2 | 29 |
| 2021 | 2 | 233 |
Compare with all 510(k) review times · Search every OQG clearance
Top OQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kyocera Medical Technologies, Inc. | 3 | 2021-04-02 |
| Encore Medical L.P. | 3 | 2017-12-13 |
| Total Joint Orthopedics, Inc. | 2 | 2017-10-27 |
| Stelkast Company | 2 | 2012-10-09 |
| Microport Orthopedics, Inc. | 1 | 2021-08-20 |
9 more applicants have OQG clearances. See the full list in Caduvo.
Most recent OQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202705 | Microport Orthopedics, Inc. | Prime and DYNASTY® Additive Manufacturing Shells | 2021-08-20 | 338 |
| K203472 | Kyocera Medical Technologies, Inc. | KMTI Hip Replacement System | 2021-04-02 | 128 |
| K201660 | Kyocera Medical Technologies, Inc. | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 2020-07-16 | 28 |
| K200328 | Kyocera Medical Technologies, Inc. | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | 2020-03-11 | 30 |
| K172651 | Encore Medical L.P. | FMP Extended Liners | 2017-12-13 | 99 |
Recalls for OQG devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-06-16.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code OQG?
OQG is the FDA product code for hip prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented. It is a Class II device, regulated under 21 CFR 888.3358 and reviewed by the Orthopedic panel.
What device class is OQG?
Class II, regulation 21 CFR 888.3358. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQG?
Across 20 cleared submissions the average was 176 days from receipt to decision (median 142).
Which companies have the most OQG clearances?
Kyocera Medical Technologies, Inc. (3); Encore Medical L.P. (3); Total Joint Orthopedics, Inc. (2); Stelkast Company (2); Microport Orthopedics, Inc. (1).
Have OQG devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-06-16.
Next steps
- Run an FDA pathway report with predicate devices for product code OQG
- Run a recall and safety report across every OQG manufacturer
- Watch product code OQG 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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