FDA product code · Orthopedic · Class 2
KWT: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWT is FDA's product code for "Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented": a Class 2 device classified under 21 CFR 888.3650, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for KWT
Across 16 510(k) clearances under KWT decided from 2018-01-01 to 2026-10-06, the median was 106 days from FDA receipt to decision. Half took between 82 and 237 days, and 80% were decided within 251 days. These are past clearances, not a forecast for a new submission.
| Fastest | 42 |
|---|---|
| 25th percentile | 82 |
| Median | 106 |
| 75th percentile | 237 |
| 80th percentile | 251 |
| 90th percentile | 260 |
| Slowest | 387 |
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.
KWT in the public FDA record
| 510(k) clearances, all years | 71 |
|---|---|
| Device recalls | 31 |
| Establishment listings | 909 |
| GUDID device identifiers | 7,460 |
Counts of records, not of devices or events. Adverse event reports for KWT 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 KWT
23 FDA recognized consensus standards cite KWT, 2 of them recognized only in part, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F2028-17. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-330 ASTM F2028-17 (partial recognition) — Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
- 11-342 ASTM F732-17 (Reapproved 2025) — Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
- 11-360 ASTM F1378-18e1 — Standard Specification for Shoulder Prostheses
- 11-366 ASTM F2381-19 — Standard Test Method for Evaluating Trans-Vinylene Yield in Irradiated Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy
- 11-405 ASTM F1829-23 — Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear
- 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
- 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
- 11-433 ASTM F2028-25a (partial recognition) — Standard Test Methods for Dynamic Evaluation of Glenoid Loosening
- 8-195 ASTM F2024-10 (Reapproved 2016) — Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
- 8-368 ASTM F2625-10 (Reapproved 2016) — Standard Test Method for Measurement of Enthalpy of Fusion Percent Crystallinity and Melting Point of Ultra-High-Molecular Weight Polyethylene by Means of Differential Scanning Calorimetry
- 8-378 ASTM D792-13 — Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
- 8-379 ISO 11542-2 First edition 1998-11-15 — Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
- 8-403 ASTM D638-14 — Standard Test Method for Tensile Properties of Plastics
The first 15 of 23 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.