FDA product code OOG: Knee Arthroplasty Implantation System
OOG is the FDA product code for knee arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel. FDA has cleared 2 510(k) submissions under OOG, 1 in the last five years, from 2 different applicants. The average 510(k) review took 208 days (median 208). FDA has posted 3 recalls for OOG devices.
Definition
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
Classification
| Field | Value |
|---|---|
| Device name | Knee Arthroplasty Implantation System |
| Device class | Class II |
| Regulation | 21 CFR 888.3560 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for OOG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 150 |
| 2023 | 1 | 267 |
Compare with all 510(k) review times · Search every OOG clearance
Top OOG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Enhatch, Inc. | 1 | 2023-12-20 |
| Conformis, Inc. | 1 | 2021-04-19 |
Most recent OOG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K230850 | Enhatch, Inc. | United Orthopedic Knee Patient Specific Instrumentation | 2023-12-20 | 267 |
| K203421 | Conformis, Inc. | Triathlon AS-1 | 2021-04-19 | 150 |
Recalls for OOG devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-08-31.
Frequently asked questions
What is FDA product code OOG?
OOG is the FDA product code for knee arthroplasty implantation system. It is a Class II device, regulated under 21 CFR 888.3560 and reviewed by the Orthopedic panel.
What device class is OOG?
Class II, regulation 21 CFR 888.3560. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOG?
Across 2 cleared submissions the average was 208 days from receipt to decision (median 208).
Which companies have the most OOG clearances?
Enhatch, Inc. (1); Conformis, Inc. (1).
Have OOG devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2015-08-31.
Next steps
- Run an FDA pathway report with predicate devices for product code OOG
- Run a recall and safety report across every OOG manufacturer
- Watch product code OOG 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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