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FDA product code · Orthopedic · Class 2

JDW: Pin, Fixation, Threaded

JDW is FDA's product code for "Pin, Fixation, Threaded": 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 JDW

Across 11 510(k) clearances under JDW decided from 2018-01-01 to 2026-10-06, the median was 76 days from FDA receipt to decision. Half took between 46 and 199 days, and 80% were decided within 253 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, JDW, decisions 2018-01-01 to 2026-10-06 (n = 11)
Fastest17
25th percentile46
Median76
75th percentile199
80th percentile253
90th percentile267
Slowest286

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.

JDW in the public FDA record

Records naming JDW, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years94
Device recalls100
Establishment listings450
GUDID device identifiers9,028

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

24 FDA recognized consensus standards cite JDW, 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
  • 11-327 ASTM F543-17 — Standard Specification and Test Methods for Metallic Medical Bone Screws
  • 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
  • 11-428 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
  • 11-74 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 24 are shown. Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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