Tibial Insert

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

510(k) Number

K963028 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

• 6.5 Mm Cancellous Bone Screw

  Class II

  FDA 510(k) K931665 Active Cleared 17 Feb 1994

• Berlin External Fixator

  Class II

  FDA 510(k) K954053 Active Cleared 16 May 1996

• Modification to Isobar Spinal System

  Class II

  FDA 510(k) K000020 Active Cleared 3 Feb 2000

• Foundation Knee Augmentation Blocks

  Class II

  FDA 510(k) K941306 Active Cleared 8 Feb 1995

• Foundation Porous Coated Hemispherical Shell

  Class II

  FDA 510(k) K974093 Active Cleared 28 Jan 1998

• Press-Fit Porous Shell

  Class II

  FDA 510(k) K961526 Active Cleared 17 Sep 1996

See all devices from Encore Orthopedics, Inc. →

• What is the primary purpose of the Tibial Insert in knee replacement surgeries?

  The Tibial Insert acts as the intermediate bearing surface between the tibia (shinbone) and femur (thighbone) in total knee arthroplasty. Its design allows for smooth articulation with the femoral component, enabling natural joint movement and proper load distribution during knee replacement procedures.

• Is the Tibial Insert intended for reuse or is it a single-use implant?

  The Tibial Insert is explicitly supplied as a single-use implant, meaning it is intended for one-time surgical use only and should not be reused after implantation.

• How is the Tibial Insert regulated by the FDA, and what does that mean for its use?

  The Tibial Insert holds an FDA 510(k) clearance (K963028) under the product code JWH, which categorizes it as an orthopedic device. This clearance indicates that the manufacturer has demonstrated it is substantially equivalent to a legally marketed device in terms of safety and effectiveness for its intended use in knee replacement surgeries.

• Are there any specific storage instructions mentioned for the Tibial Insert?

  The provided data does not include explicit storage instructions for the Tibial Insert. However, as a single-use surgical implant, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures to preserve its integrity until use.