Biosphere Suture Anchor

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

510(k) Number

K963396 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Straight Paddle Surgical Cautery Electrode Blade

  Class II

  FDA 510(k) K890973 Active Cleared 22 Mar 1989

• Gravity Assist

  Class I

  FDA 510(k) K902854 Active Cleared 29 Aug 1990

• Bone Screws

  Class II

  FDA 510(k) K923841 Active Cleared 27 Oct 1993

• Makar Mini Cannulated Cancellous Screws

  Class II

  FDA 510(k) K912021 Active Cleared 22 Nov 1991

• I.M. Arthroscope

  Class II

  FDA 510(k) K821847 Active Cleared 22 Jul 1982

• Meniscal Suture Gun

  Class I

  FDA 510(k) K832978 Active Cleared 12 Dec 1983

See all devices from Instrument Makar, Inc. →

• What is the Biosphere Suture Anchor used for?

  The Biosphere Suture Anchor is a biodegradable fixation device designed for soft tissue applications in orthopedic procedures. It serves as a fastener to secure tissues during surgical interventions.

• How is the Biosphere Suture Anchor supplied?

  The device is supplied in various sizes as indicated by the registration numbers. Each size is designed to accommodate different clinical requirements and anatomical considerations during orthopedic procedures.

• Is the Biosphere Suture Anchor single-use or reusable?

  The device is designed for single-use applications. As a biodegradable fixation device, it is not intended to be reused to ensure patient safety and maintain device integrity.

• What is the regulatory status of the Biosphere Suture Anchor?

  The Biosphere Suture Anchor is a Class II device that received FDA 510(k) clearance with number K963396 on May 6, 1997, under regulation 888.3030. It is classified as substantially equivalent to predicate devices.