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FDA 510(k)

TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM

K-Number: K031729 · 2003-09-02

ApplicantHowmedica Osteonics Corp.
Decision Date2003-09-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2003-09-02 under 510(k) number K031729. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM?

TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-02. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K031729.

When did TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2003-09-02, under 510(k) number K031729.

Who is the listed applicant for TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM?

The FDA 510(k) record lists Howmedica Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM?

The FDA product code for TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM is JWH.

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Other records listing Howmedica Osteonics Corp. as applicant

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Related Devices (Code: JWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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