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P.F.C. Mod Total Knee/Condyl 3 Fem Comp Tib Insert

by Johnson & Johnson Orthopaedics, Inc.

510(k) K924340

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924340 Date25 Jan 1994ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JWH
Device Class
Class II
Regulation
21 CFR Part 888.3560
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a femoral component and tibial insert for use in total knee arthroplasty, specifically designed as part of the P.F.C. MOD TOTAL KNEE/CONDYL 3 system. It functions as a modular implant component to replace the distal femur and proximal tibia in patients requiring knee reconstruction due to joint degeneration or injury. The device is intended to provide a stable articulating surface and facilitate load distribution across the knee joint.

The device is supplied as a sterile, single-use implant intended for surgical implantation in a clinical setting. It is manufactured by Johnson & Johnson Orthopaedics, Inc. and was cleared under the FDA 510(k) process with the reference number K924340. The device is categorized under the orthopedic product code JWH and is designed for use in total knee replacement procedures. Storage conditions and specific handling instructions are not detailed in the available data.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical situation is this implant designed for?

    It is intended for total knee arthroplasty, replacing the distal femur and proximal tibia in patients whose knee joint has degenerated or been injured, providing a stable articulating surface and load distribution.

  • How is the device supplied and what are its sterility requirements?

    The implant is supplied sterile and as a single‑use component, meaning it must be used only once in a surgical procedure and cannot be re‑sterilized or reused.

  • Is the femoral component and tibial insert a single product or separate parts?

    They are packaged together as a modular system for the P.F.C. MOD TOTAL KNEE/CONDYL 3 platform, allowing the surgeon to implant both the femoral component and tibial insert in one procedure.

  • What regulatory pathway was used for this device?

    The device received clearance through the FDA 510(k) process (reference K924340), indicating it was found substantially equivalent to a legally marketed predicate device.

  • Are there any specific storage or handling instructions provided?

    The available data do not detail storage conditions or handling instructions, so users should follow standard sterile implant protocols and any manufacturer guidance.