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FDA 510(k)

Shoulder Soft Tissue Anchors

K-Number: K242477 · 2025-05-12

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-05-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoulder Soft Tissue Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K242477. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoulder Soft Tissue Anchors?

Shoulder Soft Tissue Anchors is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K242477.

When did Shoulder Soft Tissue Anchors receive FDA 510(k) clearance?

Shoulder Soft Tissue Anchors received FDA 510(k) clearance on 2025-05-12, under 510(k) number K242477.

Who is the listed applicant for Shoulder Soft Tissue Anchors?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shoulder Soft Tissue Anchors?

The FDA product code for Shoulder Soft Tissue Anchors is MBI.

Related Clinical Trials

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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