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NEO PS Knee System

by Pipeline Orthopedics

510(k) K122500

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 NumberK122500 Date3 May 2013ClearedStatusActive

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  • Withdrawn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, 28 Sep 2026

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

The NEO PS Knee System is a total knee replacement system indicated for skeletally mature individuals with severe knee pain and disability, including those with excised posterior cruciate ligament. It is designed for use in patients with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities, and femoral condyle osteonecrosis. The system includes femoral components, tibial inserts, tibial trays, patellar components, and surgical instrumentation, and is intended for high-flexion use up to 150 degrees.

The device is supplied as a single-use system and must be used with cement. It is intended for use by orthopedic surgeons in clinical or hospital settings. The system is designed to accommodate moderate valgus, varus, or flexion deformities. Storage conditions and specific handling instructions are not detailed in the provided data. The device was reviewed under FDA 510(k) with a substantially equivalent decision.

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Questions

AI-generated answers, 28 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 conditions is the NEO PS Knee System indicated for?

    It is indicated for skeletally mature individuals with severe knee pain and disability, including those with excised posterior cruciate ligament. It is designed for use in patients with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities, and femoral condyle osteonecrosis.

  • How is the NEO PS Knee System supplied and used?

    It is supplied as a single-use system and must be used with cement. It is intended for use by orthopedic surgeons in clinical or hospital settings.

  • What deformities can the NEO PS Knee System accommodate?

    The system is designed to accommodate moderate valgus, varus, or flexion deformities.

  • What is the maximum flexion capability of the NEO PS Knee System?

    The system is intended for high-flexion use up to 150 degrees.

  • What components are included in the NEO PS Knee System?

    The system includes femoral components, tibial inserts, tibial trays, patellar components, and surgical instrumentation.