FDA product code · Orthopedic · Class 2
HSB: Rod, Fixation, Intramedullary And Accessories
HSB is FDA's product code for "Rod, Fixation, Intramedullary And Accessories": a Class 2 device classified under 21 CFR 888.3020, reviewed by the Orthopedic panel. FDA flags it as an implant.
510(k) review time for HSB
Across 125 510(k) clearances under HSB decided from 2018-01-01 to 2026-10-06, the median was 134 days from FDA receipt to decision. Half took between 84 and 238 days, and 80% were decided within 248 days. These are past clearances, not a forecast for a new submission.
| Fastest | 17 |
|---|---|
| 25th percentile | 84 |
| Median | 134 |
| 75th percentile | 238 |
| 80th percentile | 248 |
| 90th percentile | 268 |
| Slowest | 592 |
| Year | Median days | n |
|---|---|---|
| 2018 | 134 | 17 |
| 2019 | 132 | 13 |
| 2020 | 112 | 17 |
| 2021 | 94 | 10 |
| 2022 | 172 | 12 |
| 2023 | 162 | 11 |
| 2024 | 195 | 13 |
| 2025 | 106 | 15 |
| 2026 (to 10-06, partial) | 147 | 17 |
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.
HSB in the public FDA record
| 510(k) clearances, all years | 530 |
|---|---|
| Device recalls | 690 |
| Establishment listings | 1,638 |
| GUDID device identifiers | 38,757 |
Counts of records, not of devices or events. Adverse event reports for HSB 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 HSB
13 FDA recognized consensus standards cite HSB, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F1611-00 (Reapproved 2018). 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
- 11-310 ASTM F1611-00 (Reapproved 2018) — Standard Specification for Intramedullary Reamers
- 11-316 ASTM F1264-16 — Standard Specification and Test Methods for Intramedullary Fixation Devices
- 11-326 ASTM F384-17 — Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
- 11-355 ISO 15142-1 First edition 2003-08-01 — Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails
- 11-356 ISO 15142-2 First edition 2003-08-01 — Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components
- 11-357 ISO 15142-3 First edition 2003-08-01 — Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter instruments
- 11-411 ASTM F1611-20 (Reapproved 2024) — Standard Specification for Intramedullary Reamers
- 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
- 11-427 ASTM F1264-24 — Standard Specification and Test Methods for Intramedullary Fixation Devices
- 11-431 ASTM F384-24 — Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.