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Compress Device 178757

by Biomet Orthopedics, Inc.

Compress Device 178757 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K183553 on 22 Jan 2019 (3 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304509672), active as of 23 Oct 2026. One FDA recall is linked to it.

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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK183553 Date22 Jan 2019DecidedStatusActive
United StatesGUDID listing Number00880304509672 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183553 decided 22 Jan 2019 Active· +3 more in the status table
  • FDA GUDID UDI-DI 00880304509672 listed 24 Oct 2015 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0519-2020 FDA Class II initiated 21 Aug 2019

    Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

    • Terminated Z-0642-2019 FDA Class II initiated 12 Oct 2018 on shared 510(k) K112905

    Correction to update the surgical technique for the Compress System. To make users aware of the changes that were made only to the selection criteria section on page 42 regarding which array to use in the placement of the anti-rotation pins.

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K112905
  2. Cleared FDA 510(k) K123297
  3. Listed FDA GUDID 00880304509672
  4. Cleared FDA 510(k) K173411
  5. Recall initiated FDA recalls Z-0642-2019
  6. Cleared FDA 510(k) K183553
  7. Recall initiated FDA recalls Z-0519-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Compress Device
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
178757
Primary DI / UDI-DI
00880304509672
510(k) Number
FDA product code
KWS, JDC, MBF, KWT, LZO, JDI, LPH, KWY, MEH, KRO, KWZ, PHX
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class II
Regulation number
888.3660, 888.3150, 888.3670, 888.3650, 888.3353, 888.3350, 888.3358, 888.3390, 888.3510, 888.3310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K112905)

and 8 more cleared under K112905

Cleared under the same submission (K123297)

and 8 more cleared under K123297

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)