Kinematic II Replacement Tibial Inserts

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

510(k) Number

K960976 ↗

FDA Product Code

JWH

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

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See all devices from Howmedica Corp. →

• What is the primary purpose of the Kinematic II Replacement Tibial Inserts?

  These inserts are modular polyethylene bearings designed for use during revision knee surgery. They are specifically indicated when the original Vitallium baseplate is still well-fixed, but the polyethylene bearing has worn out or there is ligament laxity, thereby restoring joint articulation and stability.

• How are these inserts supplied and are they intended for reuse?

  The inserts are supplied as single-use components. They are intended for intraoperative use by orthopedic surgeons and are not designed or approved for reprocessing or reuse in subsequent procedures.

• What is the regulatory classification and clearance history for this device?

  The device is classified under FDA product code JWH. It was cleared through the 510(k) premarket notification pathway under number K960976, receiving a substantial equivalence determination for some indications on August 7, 1996.

• Which existing knee system are these inserts compatible with?

  They are designed specifically for use with existing Kinematic II total knee systems. They are modular components that function in conjunction with the system's Vitallium baseplate.