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Polarcup 75100407

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

1 ongoing

This device is named in the recall

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 NumberK211176 Date1 Jul 2022IssuedStatusActive
United StatesGUDID listing Number07611996117981 UDI-DI Date25 Nov 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0326-2025 FDA Class II initiated 15 Oct 2024

    The Bipolar assembly contains an oversized Retainer Ring.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Polarcup
Generic name
Acetabular shell
Model / Ref / Catalog
75100407
Primary DI / UDI-DI
07611996117981
510(k) Number
FDA product code
LZO, LWJ, JDI, KWY, LPH
GMDN term
Acetabular shell
Device class
Class II
Regulation number
888.3353, 888.3360, 888.3350, 888.3390, 888.3358
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Acetabular shell

Cleared under the same submission (K110135)

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Cleared under the same submission (K211176)

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Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

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