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Sterile Button Plate

by Synthes (Usa) 510(k)

Active United States

510(k) K010121

Overview

The Sterile Button Plate is a fastener, fixation, nondegradable, soft tissue device classified within the MBI product code category for soft tissue fixation fasteners and anchoring systems. It is intended for use in orthopedic applications as a device for securing soft tissue.

The device is supplied sterile and is a single-use implant. It received FDA 510(k) clearance (K010121) on February 9, 2001, as substantially equivalent to a predicate device under special controls. The device is manufactured by Synthes (USA) and is regulated as a Class II medical device.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010121 Date9 Feb 2001ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Synthes (Usa)

See all devices from Synthes (Usa) →

Questions

  • What is the Sterile Button Plate used for?

    The Sterile Button Plate is intended for use in orthopedic applications as a device for securing soft tissue. It functions as a fastener and fixation device for soft tissue anchoring, classified under the MBI product code category for soft tissue fixation fasteners and anchoring systems.

  • Is the Sterile Button Plate sterile and single-use?

    Yes, the Sterile Button Plate is supplied sterile and is designed as a single-use implant. This means it is intended for one-time use only and should not be reprocessed or reused after initial implantation to maintain sterility and structural integrity.

  • What regulatory pathway was used for the Sterile Button Plate?

    The Sterile Button Plate received FDA 510(k) clearance under submission number K010121 on February 9, 2001. It was determined to be substantially equivalent to a predicate device and is regulated as a Class II medical device under special controls.