Innovasive Devices Meniscal Dart Repair System

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

510(k) Number

K981340 ↗

FDA Product Code

MAI

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Innovasive Devices Intratunnel Tibial Fixation Fastener

  Class II

  FDA 510(k) K983560 Active Cleared 28 Jan 1999

• Y-Knot Suture Clip

  Class II

  FDA 510(k) K973313 Active Cleared 1 Dec 1997

• Bioroc Ez Suture Bone Fastener

  Class II

  FDA 510(k) K973381 Active Cleared 18 Feb 1998

• Innovasive Tibial Fastener

  Class II

  FDA 510(k) K983056 Active Cleared 13 Oct 1998

• Rc Tack

  Class II

  FDA 510(k) K992377 Active Cleared 8 Oct 1999

• Innovasive 2.3mm Roc Xs Suture Bone Fastener

  Class II

  FDA 510(k) K972438 Active Cleared 26 Sep 1997

See all devices from Innovasive Devices, Inc. →

• What is the Innovasive Devices Meniscal Dart Repair System used for?

  The system is used for meniscal repair in orthopedic surgery. It approximates the tear to facilitate healing in the vascularized region of the meniscus by securing tissue with its barbs and back tab design during arthroscopic procedures.

• What material is the Meniscal Dart Repair System made from and how does it function in the body?

  The device is fabricated from L-PLA, a bioabsorbable polymer. It functions by providing temporary fixation to approximate meniscal tissue, then gradually absorbs as healing progresses, eliminating the need for removal.

• How is the Meniscal Dart Repair System delivered and deployed during surgery?

  The device is inserted into the meniscus using a dedicated inserter instrument during arthroscopic surgery. Its molded back tab and barbs along the length engage tissue to secure the repair and approximate the tear site.

• Is the Meniscal Dart Repair System reusable or intended for single use?

  The system is intended for single use. As a bioabsorbable implant designed to remain in the body temporarily and absorb over time, it is not designed for cleaning, resterilization, or reuse in another procedure.

• What regulatory pathway was used for the Meniscal Dart Repair System and what is its classification?

  The device received FDA 510(k) clearance under submission K981340 and is classified as a Class 2 medical device under regulation number 888.3030, indicating it is a biodegradable soft tissue fixation fastener.