FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

K Number

K260561

Validate with FDA (Live)

Device Name

Arthrex FiberTak Suture Anchor

Manufacturer

Arthrex, Inc.

Date Cleared

2026-03-20

(29 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253886

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Device Name

Grappler Suture Anchor PCFD Tether System

Manufacturer

Paragon 28, Inc.

Date Cleared

2026-03-17

(103 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254176

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Device Name

SINEFIX

Manufacturer

BAAT Medical Products B.V.

Date Cleared

2026-03-16

(83 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K251750

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Device Name

Trax EX Anchor

Manufacturer

Trax Surgical, Inc.

Date Cleared

2026-03-12

(276 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253693

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Device Name

Strut Suture; No-Tie Button

Manufacturer

Riverpoint Medical, LLC

Date Cleared

2026-03-11

(110 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K260405

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Device Name

FiberTape Button

Manufacturer

Arthrex, Inc.

Date Cleared

2026-03-09

(28 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253538

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Device Name

TeKBrace Knotless Anchor

Manufacturer

Theramicro

Date Cleared

2026-03-06

(113 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254306

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Device Name

Aevumed FENIX Suture Anchor

Manufacturer

Aevumed, Inc.

Date Cleared

2026-03-04

(63 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K254229

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Device Name

Arthrex Nano FiberTak Suture Anchor

Manufacturer

Arthrex, Inc.

Date Cleared

2026-03-02

(63 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

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K Number

K253695

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Device Name

LigaMend

Manufacturer

Riverpoint Medical, LLC

Date Cleared

2026-02-27

(98 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

K230212,K243988,K202399,K203495

Predicate For

N/A

Intended Use

The LigaMend devices are intended to be used for fixation of soft tissue to bone and are intended as fixation over areas of ligament or tendon repair, in the following procedures:
• Shoulder: Biceps Tenodesis, Acromio-Clavicular Separation Repair
• Foot/Ankle: Achilles Tendon Repair.
• Knee: Meniscal Root Repair, MPFL Repair, ACL/PCL repair

Device Description

LigaMend is a fixation loop composed of UHMWPE (ultra-high molecular weight polyethylene) with UHMWPE tracer material. Fixation loops are available with an attachable fixation anchor composed of a titanium (Ti-6Al-4V) button, or with an attached UHMWPE fixation button. LigaMend devices will be provided sterile using ethylene oxide, for single use only, and are not to be re-sterilized.

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