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USTAR II Knee System 2315-2211-RA

by United Orthopedic Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

4 ongoing

This device is named in the recall

Documents

None

No authorization 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 StatesGUDID listing Number04719886912692 UDI-DI Date24 Feb 2026ListedStatusListed GUDID: in commercial distribution

Recalls

5 recalls · 4 ongoing · FDA

    • Ongoing Z-2884-2026 FDA Class II initiated 20 May 2026

    Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.

  • 3 recalls, same reason

    • Ongoing Z-1216-2024 FDA Class II initiated 3 Jan 2024
    • Ongoing Z-1215-2024 FDA Class II initiated 3 Jan 2024
    • Ongoing Z-1217-2024 FDA Class II initiated 3 Jan 2024

    Their is a potential that the implant curved stem may be oriented incorrectly.

    • Terminated Z-0110-2022 FDA Class II initiated 27 Aug 2021

    Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
USTAR II Knee System
Generic Name
Knee tibia prosthesis trial, reusable
Model / Ref / Catalog
2315-2211-RA
Primary DI / UDI-DI
04719886912692
510(k) Number
FDA Product Code
KRO, LPH, LWJ, KWL
GMDN Term
Knee tibia prosthesis trial, reusable
Device Class
Class II
Regulation Number
888.3510, 888.3358, 888.3360
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K190100)

Show all (12)

Other devices from United Orthopedic Corp.

See all devices from United Orthopedic Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No