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FDA product code · Orthopedic · Class 2

HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

HSN is FDA's product code for "Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer": a Class 2 device classified under 21 CFR 888.3110, reviewed by the Orthopedic panel. FDA flags it as an implant.

510(k) review time for HSN

Across 34 510(k) clearances under HSN decided from 2018-01-01 to 2026-10-06, the median was 114 days from FDA receipt to decision. Half took between 59 and 203 days, and 80% were decided within 225 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, HSN, decisions 2018-01-01 to 2026-10-06 (n = 34)
Fastest24
25th percentile59
Median114
75th percentile203
80th percentile225
90th percentile262
Slowest316
Median days by decision year, HSN (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20202346
20231126
20241157

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.

HSN in the public FDA record

Records naming HSN, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years68
Device recalls47
Establishment listings264
GUDID device identifiers4,536

Counts of records, not of devices or events. Adverse event reports for HSN 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 HSN

15 FDA recognized consensus standards cite HSN, among them ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018); ASTM F732-17 (Reapproved 2025). 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
  • 11-342 ASTM F732-17 (Reapproved 2025) — Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
  • 11-362 ISO 22622 First edition 2019-07 — Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameters for wear-testing machines with load or displacement control and corresponding environmental conditions for test
  • 11-386 ASTM F2665-21 — Standard Specification for Total Ankle Replacement Prosthesis
  • 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
  • 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
  • 8-514 ISO 5834-2 Fifth edition 2019-02 — Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms
  • 8-572 ASTM F2565-21 — Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
  • 8-573 ASTM F2695-12(2025) — Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
  • 8-577 ISO 13179-1 Second Edition 2021-09 — Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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