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Pipeline Knee System

by Pipeline Orthopedics 2 variants

510(k) K123692

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 NumberK123692 Date24 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  • Withdrawn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, 6 Oct 2026

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

The Pipeline Knee System is a Class 2 orthopedic device with product code JWH. It is indicated for skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the bone.

The device was cleared through the FDA 510(k) Traditional pathway under K123692, with a decision date of May 24, 2013. It is manufactured by Pipeline Orthopedics located at 901 King St., Suite 200, Alexandria, VA 22314.

Other devices from Pipeline Orthopedics

See all devices from Pipeline Orthopedics →

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Pipeline Knee System used for?

    The Pipeline Knee System is indicated for skeletally mature patients experiencing severe knee pain and disability caused by rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, or avascular necrosis of the bone, as stated in its FDA 510(k) clearance.

  • How was the Pipeline Knee System cleared for market?

    The Pipeline Knee System received market clearance through the FDA 510(k) Traditional pathway under submission K123692, with a substantially equivalent decision issued on May 24, 2013, based on its classification as a Class 2 device with product code JWH.

  • Who manufactures the Pipeline Knee System and where is it located?

    The Pipeline Knee System is manufactured by Pipeline Orthopedics, located at 901 King St., Suite 200, Alexandria, VA 22314, as specified in the device’s FDA 510(k) submission and authorization records.