FDA product code · Orthopedic · Class 2
KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWY is FDA's product code for "Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented": a Class 2 device classified under 21 CFR 888.3390, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for KWY
Across 15 510(k) clearances under KWY decided from 2018-01-01 to 2026-10-06, the median was 129 days from FDA receipt to decision. Half took between 57 and 208 days, and 80% were decided within 210 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 57 |
| Median | 129 |
| 75th percentile | 208 |
| 80th percentile | 210 |
| 90th percentile | 251 |
| Slowest | 452 |
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.
KWY in the public FDA record
| 510(k) clearances, all years | 99 |
|---|---|
| Device recalls | 88 |
| Establishment listings | 1,165 |
| GUDID device identifiers | 13,166 |
Counts of records, not of devices or events. Adverse event reports for KWY 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 KWY
42 FDA recognized consensus standards cite KWY, among them ASTM F1875-98 (Reapproved 2022); ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 11-183 ASTM F1875-98 (Reapproved 2022) — Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- 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
- 11-272 ASTM F1714-96 (Reapproved 2025) — Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
- 11-277 ISO 7206-6 Second edition 2013-11-15 — Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
- 11-312 ISO 7206-4 Third edition 2010-06-15 — Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)]
- 11-314 ISO 14242-2 Second edition 2016-09-15 — Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement
- 11-337 ISO 16087 First edition 2013-10-01 — Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants
- 11-338 ISO 11491 First edition 2017-07 — Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses
- 11-339 ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15 — Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces made of metallic ceramic and plastics materials [Including AMENDMENT1 (2016) ]
- 11-344 ASTM F2580-18 — Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis
- 11-349 ISO 14242-3 First edition 2009-03-15 — Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)]
- 11-352 ISO 14242-1 Third edition 2014-10-15 — Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2018)]
- 11-358 ISO 14242-4 First edition 2018-05 — Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
- 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
The first 15 of 42 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.