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Comprehensive SRS 211298

by Biomet Orthopedics, Inc.

Comprehensive SRS 211298 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K173411 on 8 Feb 2018 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304714748), 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

1 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 NumberK173411 Date8 Feb 2018DecidedStatusActive
United StatesGUDID listing Number00880304714748 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173411 decided 8 Feb 2018 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304714748 listed 24 Oct 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-1173-2018 FDA Class II initiated 28 Feb 2018

    During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.

Timeline

4 dated events

  1. Cleared FDA 510(k) K111746
  2. Listed FDA GUDID 00880304714748
  3. Cleared FDA 510(k) K173411
  4. Recall initiated FDA recalls Z-1173-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive SRS
Generic name
Coated shoulder humeral stem prosthesis
Model / Ref / Catalog
211298
Primary DI / UDI-DI
00880304714748
510(k) Number
FDA product code
KWS, MBF, KWT, JDC, PHX
GMDN term
Coated shoulder humeral stem prosthesis
Device class
Class II
Regulation number
888.3660, 888.3670, 888.3650, 888.3150
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Coated shoulder humeral stem prosthesis

Cleared under the same submission (K111746)

and 8 more cleared under K111746

Cleared under the same submission (K173411)

and 8 more cleared under K173411

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)