FDA product code · Orthopedic · Class 2
HWC: Screw, Fixation, Bone
HWC is FDA's product code for "Screw, Fixation, Bone": a Class 2 device classified under 21 CFR 888.3040, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for HWC
Across 205 510(k) clearances under HWC decided from 2018-01-01 to 2026-10-06, the median was 102 days from FDA receipt to decision. Half took between 57 and 183 days, and 80% were decided within 213 days. These are past clearances, not a forecast for a new submission.
| Fastest | 19 |
|---|---|
| 25th percentile | 57 |
| Median | 102 |
| 75th percentile | 183 |
| 80th percentile | 213 |
| 90th percentile | 264 |
| Slowest | 449 |
| Year | Median days | n |
|---|---|---|
| 2018 | 106 | 20 |
| 2019 | 108 | 30 |
| 2020 | 75 | 28 |
| 2021 | 84 | 26 |
| 2022 | 167 | 26 |
| 2023 | 104 | 24 |
| 2024 | 90 | 17 |
| 2025 | 111 | 15 |
| 2026 (to 10-06, partial) | 130 | 19 |
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.
HWC in the public FDA record
| 510(k) clearances, all years | 1,065 |
|---|---|
| Device recalls | 388 |
| Establishment listings | 6,619 |
| GUDID device identifiers | 136,001 |
Counts of records, not of devices or events. Adverse event reports for HWC 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 HWC
23 FDA recognized consensus standards cite HWC, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F1839-08 (Reapproved 2021). 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
- 11-242 ASTM F1839-08 (Reapproved 2021) — Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
- 11-327 ASTM F543-17 — Standard Specification and Test Methods for Metallic Medical Bone Screws
- 11-363 ASTM F897-19 — Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws
- 11-378 ASTM F2502-17 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 11-413 ASTM F543-23 — Standard Specification and Test Methods for Metallic Medical Bone Screws
- 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
- 11-438 ASTM F2502-24 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 8-475 ASTM F2026-17 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
- 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
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.