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Ceterix NovoStitch Instructions For Use Manual

Disposable suture passer
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The Ceterix™ NovoStitch™ Disposable Suture Passer
Ceterix Orthopaedics
959 Hamilton Avenue
Menlo Park, CA 94025
Customer Service: (650) 241-1748
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THE CETERIX NOVOSTITCH DISPOSABLE SUTURE PASSER
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
DESCRIPTION
The Ceterix NovoStitch Disposable Suture Passer device is an arthroscopic suture passer designed to
pass USP size 2-0 or 0 braided surgical suture through soft tissue in arthroscopic surgery. The device has
a diameter less than 6.5mm. The needle is retractable.
INDICATION FOR USE
The device is indicated for passing suture through soft tissue in orthopaedic surgery.
CONTRAINDICATIONS
The device is not to be used on bone or other hard tissue.
P/N: LBL-0012
Rev: E
Sterile
Do Not Reuse
See Instructions for Use
Page 1

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Summary of Contents for Ceterix NovoStitch

  • Page 1 CAUTION: Federal law restricts this device to sale by or on the order of a physician. DESCRIPTION The Ceterix NovoStitch Disposable Suture Passer device is an arthroscopic suture passer designed to pass USP size 2-0 or 0 braided surgical suture through soft tissue in arthroscopic surgery. The device has a diameter less than 6.5mm.

  • Page 2: Preparations For Use

    Read the Instructions for Use in its entirety prior to use of the device. Inspect the device prior to use to ensure proper mechanical function. Figure 1: The Ceterix NovoStitch Disposable Suture Passer Radiused upper jaw Lever C – Lower jaw retractor...
  • Page 3 A. DIRECTIONS FOR USE LOADING SUTURE PASSER WITH SUTURE 1. Select USP size 2-0 or 0 braided suture and have available in the sterile field along with the device. CAUTION: Do NOT use suture other than braided USP size 2-0 or 0. 2.
  • Page 4 c. While maintaining light proximal tension on the loop, slightly squeeze Lever B so that the needle moves forward about 1 mm within the lower jaw (see Figure 4), then release Lever B. Do not fully advance Lever B at this stage. The suture strand will be locked in the lower jaw by the needle.
  • Page 5 8. If needed, repeat steps 2 through 8 using the opposing suture end. This will create a circumferential stitch. 9. Using standard surgical techniques and the Ceterix Knot Pusher Suture Cutter or commercially- available equivalent(s), advance a knot to the surface of the tissue until tissue approximation at the tear is observed.

  • Page 6: General Use

    Bench deployment testing has demonstrated that the device can be reloaded with suture and fully actuated 14 times. Cycling the device in excess of 14 deployments may impact needle integrity and compromise performance. Immediately discard the Ceterix NovoStitch Disposable Suture Passer after completion of the surgery. The device is SINGLE USE ONLY. STORAGE Store in a cool, dry area.