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Sigma 96-0083

by Depuy (Ireland)

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) from GUDID NumberK241000 Date11 Jul 2024IssuedStatusActive
United StatesGUDID listing Number10603295232506 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

8 recalls · FDA

    • Terminated Z-2949-2018 FDA Class II initiated 18 Jul 2018

    This unit may be missing the screw/collet Assembly

  • 6 recalls, same reason

    • Terminated Z-0401-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0399-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0397-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0398-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0396-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0400-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

    • Terminated Z-1369-04 FDA Unclassified (pre-2012) initiated 22 Dec 2003

    The collar was incorrectly etched for the R (right) and L (Left) orientation

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sigma
Generic name
Uncoated knee femur prosthesis, metallic
Model / Ref / Catalog
96-0083, 960083
Primary DI / UDI-DI
10603295232506
510(k) Number
FDA product code
JWH
GMDN term
Uncoated knee femur prosthesis, metallic
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Uncoated knee femur prosthesis, metallic

Cleared under the same submission (K241000)

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Cleared under the same submission (K952830)

Show all (12)

Other devices from Depuy (Ireland)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No