Skip to content

Duracon 6642-2-631

by Howmedica Osteonics Corp.

Duracon 6642-2-631 is a Class II device made by Howmedica Osteonics Corp., cleared under FDA 510(k) K951655 on 11 Jul 1995 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 04546540318503), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K951655

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04546540318503 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951655 Date11 Jul 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951655 decided 11 Jul 1995 Active
  • FDA GUDID UDI-DI 04546540318503 listed 24 Sep 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K951655
  2. Listed FDA GUDID 04546540318503

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Duracon
Generic name
Polyethylene patella prosthesis
Model / Ref / Catalog
6642-2-631
Primary DI / UDI-DI
04546540318503
510(k) Number
FDA product code
JWH
GMDN term
Polyethylene patella prosthesis
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyethylene patella prosthesis

Cleared under the same submission (K951655)

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)