FDA product code PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKC is the FDA product code for prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel. FDA has cleared 19 510(k) submissions under PKC, 9 in the last five years, from 15 different applicants. The average 510(k) review took 165 days (median 167); 127 days on average over the last three years. FDA has posted 3 recalls for PKC devices, 1 initiated in the last five years.
Definition
Replacement of the humeral head for total anatomic shoulder arthroplasty
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained |
| Device class | Class II |
| Regulation | 21 CFR 888.3660 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PKC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 180 |
| 2018 | 1 | 130 |
| 2019 | 1 | 221 |
| 2020 | 4 | 132 |
| 2021 | 2 | 270 |
| 2022 | 3 | 159 |
| 2023 | 1 | 274 |
| 2024 | 3 | 163 |
| 2025 | 1 | 88 |
| 2026 | 1 | 130 |
Compare with all 510(k) review times · Search every PKC clearance
Top PKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 2 | 2025-10-03 |
| Tornier, Inc. | 2 | 2022-09-14 |
| Arthrex, Inc. | 2 | 2020-11-20 |
| Exactech, Inc. | 2 | 2020-04-29 |
| FX Shoulder Solutions, Inc. | 1 | 2026-05-01 |
10 more applicants have PKC clearances. See the full list in Caduvo.
Most recent PKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254154 | FX Shoulder Solutions, Inc. | FX V135 EASYTECH® Shoulder System | 2026-05-01 | 130 |
| K252129 | Smith & Nephew, Inc. | AETOS Shoulder System Stemless Humeral Prosthesis | 2025-10-03 | 88 |
| K243248 | Depuy Ireland UC | INHANCE INTACT | 2024-12-23 | 73 |
| K241873 | Zimmer, Inc. | OsseoFit Stemless Shoulder System | 2024-12-11 | 167 |
| K240716 | Smith & Nephew, Inc. | AETOS Shoulder System Stemless Humeral Prosthesis | 2024-11-20 | 250 |
Recalls for PKC devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-08-29.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code PKC?
PKC is the FDA product code for prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained. It is a Class II device, regulated under 21 CFR 888.3660 and reviewed by the Orthopedic panel.
What device class is PKC?
Class II, regulation 21 CFR 888.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKC?
Across 19 cleared submissions the average was 165 days from receipt to decision (median 167).
Which companies have the most PKC clearances?
Smith & Nephew, Inc. (2); Tornier, Inc. (2); Arthrex, Inc. (2); Exactech, Inc. (2); FX Shoulder Solutions, Inc. (1).
Have PKC devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2024-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code PKC
- Run a recall and safety report across every PKC manufacturer
- Watch product code PKC 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times