FDA product code PQC: Pedicle Screw Placement Guide
PQC is the FDA product code for pedicle screw placement guide. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel. FDA has cleared 8 510(k) submissions under PQC, 2 in the last five years, from 4 different applicants. The average 510(k) review took 107 days (median 96); 138 days on average over the last three years.
Definition
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Classification
| Field | Value |
|---|---|
| Device name | Pedicle Screw Placement Guide |
| Device class | Class II |
| Regulation | 21 CFR 888.3070 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
510(k) clearances per year for PQC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 100 |
| 2020 | 1 | 193 |
| 2021 | 1 | 111 |
| 2023 | 1 | 59 |
| 2026 | 1 | 138 |
Compare with all 510(k) review times · Search every PQC clearance
Top PQC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medacta International S.A. | 3 | 2023-07-21 |
| Mighty Oak Medical, Inc. | 3 | 2018-10-03 |
| Mighty Oak Medical | 1 | 2026-02-25 |
| Medacta Inernational SA | 1 | 2020-10-05 |
Most recent PQC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253472 | Mighty Oak Medical | FIREFLY® Pedicle Screw Navigation Guide | 2026-02-25 | 138 |
| K231483 | Medacta International S.A. | MySpine Unilateral Guides | 2023-07-21 | 59 |
| K203673 | Medacta International S.A. | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) | 2021-04-06 | 111 |
| K200792 | Medacta Inernational SA | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | 2020-10-05 | 193 |
| K181883 | Mighty Oak Medical, Inc. | FIREFLY® Midline Navigation Guide | 2018-10-03 | 82 |
Recalls for PQC devices
openFDA lists no recalls for product code PQC.
Frequently asked questions
What is FDA product code PQC?
PQC is the FDA product code for pedicle screw placement guide. It is a Class II device, regulated under 21 CFR 888.3070 and reviewed by the Orthopedic panel.
What device class is PQC?
Class II, regulation 21 CFR 888.3070. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQC?
Across 8 cleared submissions the average was 107 days from receipt to decision (median 96).
Which companies have the most PQC clearances?
Medacta International S.A. (3); Mighty Oak Medical, Inc. (3); Mighty Oak Medical (1); Medacta Inernational SA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PQC
- Run a recall and safety report across every PQC manufacturer
- Watch product code PQC 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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