Home › Device types › HXI
Passer, Wire, Orthopedic
FDA product code HXI · Class 1 · Orthopedic
547
Registered devices
294
Adverse events
8
Recalls
3
510(k) clearances
Devices with this code
N/A — BIOMET MICROFIXATION, INCMemoFix Super Elastic Nitinol
Staple System — Smith & Nephew, Inc.Vilex Guidewire — VILEX IN TENNESSEE, INC.NA — Integrity Implants Inc.n/a — Ortho Development CorporationNA — Integrity Implants Inc.Ti6 Internal Fixation System — Smith & Nephew, Inc.Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc.Fracture Finger — FLOWER ORTHOPEDICS CORPORATIONLesser Metatarsal Shortening System — Paragon 28, Inc.CAPTURE™ — Ascension Orthopedics, Inc.Monster Screw System — Paragon 28, Inc.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.Vilex Guidewire — VILEX IN TENNESSEE, INC.Vilex Power Accessory — VILEX IN TENNESSEE, INC.CAPTURE™ — Ascension Orthopedics, Inc.Baby Gorilla/Gorilla Plating System — Paragon 28, Inc.CoLink — In2Bones USA, LLCCAPTURE™ — Ascension Orthopedics, Inc.MaxMoreSpine — Hoogland Spine Products GmbHIn2Bones — In2Bones USA, LLCHintermann Series — VILEX LLCAPEX 3D S Total Ankle Replacement System — Paragon 28, Inc.Vilex Guidewire — VILEX IN TENNESSEE, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Paragon 28, Inc. | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| 2016-05-20 | Integra LifeSciences Corp. | The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-w |
| 2013-01-10 | Extremity Medical LLC | The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw leng |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw |
| 2011-03-23 | Interventional Spine Inc | This recall has been initiated due to K-wires with a distal tip diameter that may be greater than specified causing an interference fit with the canulated screw |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| 2005-03-16 | EBI, L.P. | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
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