MBI · Fastener, Fixation, Nondegradable, Soft Tissue

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeMBI
Device NameFastener, Fixation, Nondegradable, Soft Tissue
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Recent Cleared Devices (20 of 589)

Showing 20 most recent of 589 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K260561Arthrex FiberTak Suture AnchorArthrex, Inc.Mar 20, 2026SESE
K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc.Mar 17, 2026SESE
K254176SINEFIXBAAT Medical Products B.V.Mar 16, 2026SESE
K251750Trax EX AnchorTrax Surgical, Inc.Mar 12, 2026SESE
K253693Strut Suture; No-Tie ButtonRiverpoint Medical, LLCMar 11, 2026SESE
K260405FiberTape ButtonArthrex, Inc.Mar 9, 2026SESE
K253538TeKBrace Knotless AnchorTheramicroMar 6, 2026SESE
K254306Aevumed FENIX Suture AnchorAevumed, Inc.Mar 4, 2026SESE
K254229Arthrex Nano FiberTak Suture AnchorArthrex, Inc.Mar 2, 2026SESE
K253695LigaMendRiverpoint Medical, LLCFeb 27, 2026SESE
K253763Y-Knotless™ Flex AnchorsConmed CorporationJan 29, 2026SESE
K260004Aevumed PROTEKT Suture AnchorAevumed, Inc.Jan 28, 2026SESE
K253618QuadLock™ Fixation SystemAbanza Tecnomed S.LJan 6, 2026SESE
K253895Arthrex SwiveLock Suture Anchor, 3.5 x 10 mmArthrex, Inc.Dec 30, 2025SESE
K252596Tigon Medical Knotless and Dual Javelin All-Suture AnchorsTigon MedicalDec 4, 2025SESE
K252664GMReis Suture AnchorsGM Dos Reis Industria e Comercio Ltda.Nov 4, 2025SESE
K252314Arthrex SutureTak Suture AnchorArthrex, Inc.Oct 29, 2025SESE
K253040Aevumed FASE Suture AnchorAevumed, Inc.Oct 21, 2025SESE
K253010Mini Superhawk Suture Anchor SystemResponsive Arthroscopy, LLCOct 14, 2025SESE
K250095All-Suture Dual Anchor SystemSuturetech, Inc.Sep 5, 2025SESE

Top Applicants

Innolitics

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