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Polarstem 75004667

by Smith & Nephew, Inc.

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

2 closed

Documents

510(k) K123598

FDA submission, from GUDID

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 Number07611996109368 UDI-DI Date13 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123598 Date28 Jun 2013DecidedStatusActive

Official records

Recalls

2 recalls · FDA

    • Terminated Z-0730-2019 FDA Class II initiated 7 Jan 2019 on shared 510(k) K123598

    The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

    • Terminated Z-1008-2017 FDA Class II initiated 16 Nov 2016

    The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

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  • Withdrawn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
Polarstem
Generic name
Medullary canal orthopaedic reamer, rigid
Model / Ref / Catalog
75004667
Primary DI / UDI-DI
07611996109368
510(k) Number
FDA product code
JDI
GMDN term
Medullary canal orthopaedic reamer, rigid
Device class
Class II
Regulation number
888.3350
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Medullary canal orthopaedic reamer, rigid

Cleared under the same submission (K123598)

Show all (12)

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied 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
  • Manufacturing date: No