FDA product code · Orthopedic · Class 2
HTY: Pin, Fixation, Smooth
HTY is FDA's product code for "Pin, Fixation, Smooth": 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 HTY
Across 34 510(k) clearances under HTY decided from 2018-01-01 to 2026-10-06, the median was 107 days from FDA receipt to decision. Half took between 58 and 176 days, and 80% were decided within 187 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 58 |
| Median | 107 |
| 75th percentile | 176 |
| 80th percentile | 187 |
| 90th percentile | 212 |
| Slowest | 359 |
| Year | Median days | n |
|---|---|---|
| 2020 | 108 | 5 |
| 2021 | 137 | 5 |
| 2023 | 146 | 5 |
| 2025 | 90 | 5 |
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.
HTY in the public FDA record
| 510(k) clearances, all years | 205 |
|---|---|
| Device recalls | 32 |
| Establishment listings | 791 |
| GUDID device identifiers | 10,327 |
Counts of records, not of devices or events. Adverse event reports for HTY 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 HTY
23 FDA recognized consensus standards cite HTY, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ISO 5838-1 Third edition 2013-03-01. 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
- 11-252 ISO 5838-1 Third edition 2013-03-01 — Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
- 11-322 ASTM F1541-17 — Standard Specification and Test Methods for External Skeletal Fixation Devices
- 11-324 ASTM F366-17 — Standard Specification for Fixation Pins and Wires
- 11-325 ASTM F564-17 — Standard Specification and Test Methods for Metallic Bone Staples
- 11-378 ASTM F2502-17 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 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
- 11-428 ASTM F1541-24 — Standard Specification and Test Methods for External Skeletal Fixation Devices
- 11-429 ASTM F366-24 — Standard Specification for Fixation Pins and Wires
- 11-430 ASTM F564-24 — Standard Specification and Test Methods for Metallic Bone Staples
- 11-438 ASTM F2502-24 — Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
- 11-74 ISO 5838-2 First edition 1991-01-15 — Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
- 11-75 ISO 5838-3 First edition 1993-09-15 — Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
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.