FDA product code · Orthopedic · Class 2
PKC: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PKC is FDA's product code for "Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained": a Class 2 device classified under 21 CFR 888.3660, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for PKC
Across 18 510(k) clearances under PKC decided from 2018-01-01 to 2026-10-06, the median was 158 days from FDA receipt to decision. Half took between 95 and 243 days, and 80% were decided within 259 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 95 |
| Median | 158 |
| 75th percentile | 243 |
| 80th percentile | 259 |
| 90th percentile | 270 |
| Slowest | 274 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
PKC in the public FDA record
| Establishment listings | 135 |
|---|---|
| GUDID device identifiers | 548 |
Counts of records, not of devices or events. Adverse event reports for PKC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite PKC
8 FDA recognized consensus standards cite PKC, among them ASTM F1829-23; ISO 5834-3 Second edition 2019-02; ISO 5834-4 Second edition 2019-02. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-405 ASTM F1829-23 — Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- 8-495 ISO 5834-3 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing methods
- 8-496 ISO 5834-4 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measurement method
- 8-497 ISO 5834-5 Second edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment method
- 8-501 ISO 5834-1 Fourth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form
- 8-514 ISO 5834-2 Fifth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
- 8-572 ASTM F2565-21 — Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
- 8-573 ASTM F2695-12(2025) — Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.