PTI Sternal Closure Wire Suture

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

510(k) Number

K910067 ↗

FDA Product Code

GAQ

Device Class

Class II

Regulation

21 CFR Part 878.4495

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Anastomart(Tm) Coronary Bypass Graft Markers/Modif

  Class II

  FDA 510(k) K922025 Active Cleared 22 Sep 1992

• Pti Heart-Chill(Tm) Cardiac Insulating Jacket

  Class II

  FDA 510(k) K874927 Active Cleared 29 Jan 1988

• Pti Intra-Artr Reusable Coronary Artery Probe

  Class II

  FDA 510(k) K901531 Active Cleared 20 Jun 1990

• Pti Intra-Art(Tm) Ansari Saphenous Vein Holder

  Class II

  FDA 510(k) K897075 Active Cleared 10 Apr 1990

• Pti Anastomark Flexible Coronary Bypass Graft

  Class II

  FDA 510(k) K905067 Active Cleared 18 Mar 1991

• Pti Heart-Lift(Tm) Cardiac Elevator (Sterile)

  Class I

  FDA 510(k) K883135 Active Cleared 26 Sep 1988

See all devices from Pioneering Technologies, Inc. →

• What is the PTI Sternal Closure Wire Suture used for?

  The PTI Sternal Closure Wire Suture is designed specifically for approximating and securing sternal edges during surgical closure, particularly in thoracic procedures such as median sternotomy. Its purpose is to provide stable internal fixation, ensuring proper alignment and healing of the sternum after surgical intervention.

• Is the PTI Sternal Closure Wire Suture single-use or reusable?

  This device is supplied as a sterile, single-use suture. It is intended for one-time use in controlled surgical environments to maintain sterility and prevent contamination, adhering to best practices for surgical instruments.

• What material is the PTI Sternal Closure Wire Suture made from?

  The suture is composed of steel wire, classified as a nonabsorbable material. Steel is chosen for its strength and durability, ensuring reliable fixation of the sternal edges during the healing process.

• How is the PTI Sternal Closure Wire Suture supplied?

  The PTI Sternal Closure Wire Suture is supplied in a sterile packaging, ready for immediate use in surgical settings. This ensures compliance with sterile surgical protocols and minimizes the risk of infection.

• What regulatory approval does the PTI Sternal Closure Wire Suture have?

  The PTI Sternal Closure Wire Suture has received FDA 510(k) clearance under the General, Plastic Surgery advisory committee, with clearance number K910067. It is classified as a Device Class II product and complies with regulatory standards outlined in 21 CFR 878.4495.