Passing Needle with Ethibond, Panacryl or Orthocord Suture

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

510(k) Number

K042233 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• OmniSpan Meniscal Repair SYSTEM/0 Degree, Model 228140, RapidLoc A2 Meniscal Repair SYSTEM/12 Degree, Model 228141

  Class II

  FDA 510(k) K092836 Active Cleared 4 Feb 2010

• Rotator Cuff Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052630 Active Cleared 17 Oct 2005

• Omnicut Resection Blade

  Class II

  FDA 510(k) K130912 Active Cleared 14 Jun 2013

• Depuy Mitek Milagro Interference Screw Model 231803, 231804, 231807, 231809

  Class II

  FDA 510(k) K103831 Active Cleared 21 Jul 2011

• Milagro Interference Screw

  Class II

  FDA 510(k) K060830 Active Cleared 15 Jun 2006

• Super Quickanchor Plus (with Orthocord Suture)

  Class II

  FDA 510(k) K052631 Active Cleared 21 Oct 2005

See all devices from Depuy Mitek, A Johnson & Johnson Company →

• What is the Passing Needle with Ethibond, Panacryl, or Orthocord Suture used for?

  This device is designed for soft tissue approximation and ligation, meaning it is used to stitch and secure tissues together during surgical procedures. Specifically, it is intended for orthopedic applications such as arthroscopic Bankart repairs and Rotator Cuff repairs, where precise tissue handling is critical for proper healing and function.

• How is the Passing Needle with Ethibond, Panacryl, or Orthocord Suture supplied, and is it sterile?

  The device is supplied sterile, ensuring it is ready for immediate use in surgical settings without additional sterilization. It is intended for single-use in vivo applications, meaning it is meant to be used once inside the body and then discarded to prevent infection or contamination.

• Is the suture absorbable, and what material is it made from?

  Yes, the suture is absorbable and made from polyglycolic acid, a synthetic material that gradually breaks down and is absorbed by the body over time. This feature reduces the need for suture removal and supports natural tissue healing.

• What are the regulatory approvals for this device?

  The Passing Needle with Ethibond, Panacryl, or Orthocord Suture holds FDA 510(k) clearance under the classification of a Class II medical device. This clearance confirms that the device meets regulatory standards for safety and effectiveness in surgical applications, specifically for use in orthopedic procedures.

• Are there different sizes or models available for this suture needle?

  The device data includes multiple FEI numbers, which correspond to different product variants or sizes of the Passing Needle with Ethibond, Panacryl, or Orthocord Suture. These variants are likely tailored to accommodate different surgical needs, such as varying tissue thickness or repair complexity. For precise sizing, refer to the product packaging or manufacturer documentation.