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Arcpm 1050 Resin-Hips

by Biomet Orthopedics, Inc.

510(k) K023357

Arcpm 1050 Resin-Hips is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K023357 on 6 Nov 2002, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK023357 Date6 Nov 2002ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1860-2017 FDA Class II initiated 17 Feb 2017 on shared 510(k) K023357

    Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

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

Timeline

2 dated events

  1. Cleared FDA 510(k) K023357
  2. Recall initiated FDA recalls Z-1860-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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