BioKnotless Anchor

• 2 recalls, same reason

  • Terminated Z-0610-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006 ·on shared 510(k) K002639
  • Terminated Z-0611-06 FDA Unclassified (pre-2012) ·initiated 17 Feb 2006 ·on shared 510(k) K002639

  The inserter shafts bend, as they were manufactured with a different stainless steel than specified.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002639 ↗

FDA Product Code

GAM

Device Class

Class II

Regulation

21 CFR Part 878.4493

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Mitek Absorbable Toggle Anchor

  Class II

  FDA 510(k) K964013 Active Cleared 24 Feb 1997

• Resolve Quickanchor

  Class II

  FDA 510(k) K993575 Active Cleared 29 Dec 1999

• Mitek Knotless Anchor

  Class II

  FDA 510(k) K974345 Active Cleared 13 Feb 1998

• Mitek Btb Absorbable (Pla) Cross Pin

  Class II

  FDA 510(k) K974341 Active Cleared 16 Apr 1998

• Rididfix 2.7mm Btb Cross Pin Kit

  Class II

  FDA 510(k) K013781 Active Cleared 6 Feb 2002

• Vapr 2.3mm Wedge Electrode for Use with Vapr System

  Class II

  FDA 510(k) K000936 Active Cleared 19 Apr 2000

See all devices from Mitek Products →

• What is the BioKnotless Anchor used for?

  The BioKnotless Anchor is designed for soft tissue to bone fixation in shoulder procedures including Bankhart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulolabral reconstruction, biceps tenodesis, and deltoid repair.

• Is the BioKnotless Anchor reusable?

  No, the BioKnotless Anchor is supplied as a single-use device and must never be reused. If the anchor should dislodge from the inserter or bone site, both the anchor and inserter should be discarded and replaced.

• What is the BioKnotless Anchor made of?

  The BioKnotless Anchor is made of absorbable synthetic polyglycolic acid material. It is MRI safe and has received FDA 510(k) clearance with product code GAM, classified as a Class II device under regulation number 878.4493.

• How is the BioKnotless Anchor supplied?

  The BioKnotless Anchor is supplied as a single-use device. It comes with an inserter, and if the anchor should dislodge from either the inserter or bone site, both components should be discarded and replaced to ensure proper function and safety.