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Osteoraptor Curved 2.3 Suture Anchors

by Smith & Nephew Endoscopy, Inc.

510(k) K103309

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103309 Date3 Feb 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Osteoraptor Curved 2.3 Suture Anchors are biodegradable soft tissue fixation devices designed for reattaching soft tissue to bone. Classified as a Fastener, Fixation device, these anchors are intended for orthopedic applications, including labral and capsular repairs in joints such as the hip and shoulder. Their curved design facilitates precise placement within anatomical structures, ensuring secure attachment while maintaining stability during the healing process. The anchors are constructed from a biodegradable material that gradually resorbs over time as the tissue integrates.

These suture anchors are supplied sterile and intended for single-use in surgical settings. They are classified as a Class II medical device under FDA regulations and have received 510(k) clearance through the Traditional pathway. The anchors are available in the specified 2.3 size and are designed for use in MRI-compatible environments, though compatibility should be verified with the imaging system in use. Storage instructions require protection from moisture and extreme temperatures to preserve sterility and functionality until use.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Osteoraptor Curved 2.3 Suture Anchor used for?

    The Osteoraptor Curved 2.3 Suture Anchor is designed for orthopedic applications to reattach soft tissue to bone. Its primary use includes labral and capsular repairs in joints such as the hip and shoulder. The curved design allows for precise placement within anatomical structures, ensuring stability during the healing process while the anchor gradually resorbs over time.

  • Are these suture anchors single-use or reusable?

    These suture anchors are intended for single-use only. They are supplied sterile and should not be reused to maintain safety and efficacy, as reuse could compromise sterility and integrity.

  • What storage conditions are required to preserve sterility and functionality?

    To preserve sterility and functionality, the Osteoraptor Curved 2.3 Suture Anchors must be stored protected from moisture and extreme temperatures. This ensures the device remains effective until use.

  • Are these anchors compatible with MRI imaging?

    The Osteoraptor Curved 2.3 Suture Anchors are designed for use in MRI-compatible environments. However, it is important to verify compatibility with the specific imaging system in use to ensure safe and accurate imaging results.

  • What material are these suture anchors made from?

    The Osteoraptor Curved 2.3 Suture Anchors are constructed from a biodegradable material. This material gradually resorbs over time as the attached soft tissue integrates with the bone, eliminating the need for removal.