Implex Continuum Knee Unity Tibial Component

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

510(k) Number

K980637 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Implex Corp. →

• What types of knee conditions is the Implex Continuum Knee Unity Tibial Component designed to address in total knee replacement surgeries?

  This tibial component is specifically designed for total knee arthroplasty to restore knee function in patients with severe joint degeneration, trauma, or degenerative joint pathology. Its porous tantalum baseplate and ultra-high-molecular-weight polyethylene bearing surfaces are engineered to provide durable support and articulation in these complex cases.

• How many thickness sizes are available for the Implex Continuum Knee Unity Tibial Component, and what are the options?

  The device comes in eight distinct thickness sizes, ranging from 10 mm to 22 mm, with an additional 26 mm option. These varied thicknesses allow surgeons to select the appropriate fit for each patient’s bone geometry during cemented total knee replacement.

• What fixation options are included with the Implex Continuum Knee Unity Tibial Component, and how do they differ?

  The tibial component offers two fixation options: hexagonal Hedrocel posts for enhanced primary stability or polyethylene fixation pegs for alternative bone integration. Both are designed to secure the component during cemented implantation, catering to different surgical preferences.

• Is the Implex Continuum Knee Unity Tibial Component intended for single-use or can it be reused after sterilization?

  The device is not explicitly described as single-use or reusable in the provided data. However, as a cemented orthopedic implant, it is typically intended for one-time surgical use per patient, following standard medical device sterilization and handling protocols for surgical instruments.

• What regulatory pathway was followed for FDA clearance of this tibial component, and what does that mean for its use?

  The Implex Continuum Knee Unity Tibial Component received FDA 510(k) clearance under product code JWH through a traditional review process, determined to be *substantially equivalent* to a legally marketed predicate device. This clearance indicates it meets FDA requirements for safety and effectiveness as a cemented tibial prosthesis in total knee arthroplasty.