FDA product code · Orthopedic · Class 2
KWL: Prosthesis, Hip, Hemi-, Femoral, Metal
KWL is FDA's product code for "Prosthesis, Hip, Hemi-, Femoral, Metal": a Class 2 device classified under 21 CFR 888.3360, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for KWL
Across 11 510(k) clearances under KWL decided from 2018-01-01 to 2026-10-06, the median was 55 days from FDA receipt to decision. Half took between 31 and 82 days, and 80% were decided within 87 days. These are past clearances, not a forecast for a new submission.
| Fastest | 12 |
|---|---|
| 25th percentile | 31 |
| Median | 55 |
| 75th percentile | 82 |
| 80th percentile | 87 |
| 90th percentile | 265 |
| Slowest | 341 |
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.
KWL in the public FDA record
| 510(k) clearances, all years | 108 |
|---|---|
| Device recalls | 50 |
| Establishment listings | 576 |
| GUDID device identifiers | 6,649 |
Counts of records, not of devices or events. Adverse event reports for KWL 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 KWL
21 FDA recognized consensus standards cite KWL, 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
- 11-277 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)]
- 11-339 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
- 11-371 ASTM F2009-20 — Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
- 11-372 ASTM F2996-20 — Standard Practice for Finite Element Analysis (FEA) of Non-Modular Metallic Orthopaedic Hip Femoral Stems
- 11-376 ASTM F2033-20 — Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic Ceramic and Polymeric Materials
- 11-385 ASTM F2345-21 — Standard Test Methods for Determination of Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- 11-389 ISO 7206-10 Second edition 2018-08 — Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads [Including AMENDMENT 1 (2021)]
- 11-395 ASTM F1814-22 — Standard Guide for Evaluating Modular Hip and Knee Joint Components
- 11-396 ISO 7206-13 First edition 2016-07-01 [Including AMD1:2022] — Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components [Including AMENDMENT 1 (2022)]
- 11-401 ISO 21535 Third edition 2023-07 — Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
The first 15 of 21 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.