FDA Device Intelligence
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Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA product code KTT · Class 2 · Orthopedic

18,260
Registered devices
10,259
Adverse events
89
Recalls
405
510(k) clearances

Devices with this code

Orthex External Fixation System — ORTHOPEDIATRICS CORP.DFS MINI LENGTHENER — Biomet Orthopedics, LLCFULLY THREADED CORTICAL SCREW — Biomet Orthopedics, LLCNA — aap Implantate AGNA — STERILMED, INC.HOFFMANN LRF — Stryker GmbHSIDEKICK — WRIGHT MEDICAL TECHNOLOGY, INC.SALVATION — WRIGHT MEDICAL TECHNOLOGY, INC.Smart Correction — Wishbone Medical, Inc.SOLID CANCELLOUS SCREW — Biomet Orthopedics, LLCVERSANAIL®UNIVERSAL FEMORAL NAIL — Biomet Orthopedics, LLCBROAD SELF - COMPRESSING PLATE — Biomet Orthopedics, LLCMetaCun™ Locking Plate — Merete GmbHeZ-Fix — ORTHOPEDIATRICS CORP.Orthex Half Pin — ORTHOPEDIATRICS CORP.NA — Synthes GmbHX Ring Fixator — EXTREMITY MEDICAL, LLCSmart Correction — Wishbone Medical, Inc.Smart Correction — Wishbone Medical, Inc.SPATIAL FRAME — Smith & Nephew, Inc.NA — Smith & Nephew, Inc.TC-100 — Smith & Nephew, Inc.SMART TSF — Smith & Nephew, Inc.POLYAX®LOCKING CORTICAL SCREW — Biomet Orthopedics, LLC

Recent recalls

DateFirmReason
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-07-01Stryker GmbHPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was lab
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was lab
2026-06-10Orthofix U.S. LLCUnilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was lab

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.