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PK J-Hook

by Gyrus Acmi, Inc.

510(k) K142350

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142350 Date8 Jan 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Completed Z-0472-2021 FDA Class II initiated 23 Oct 2020 on shared 510(k) K142350

    Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.

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

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  • Withdrawn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
GEI
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PK J-Hook is a surgical device used in general and plastic surgery procedures. It is substantially equivalent to the predicate Gyrus ACMI Plasmacision and Plasmablend electrodes (K050460).

The device is distributed by Gyrus Acmi, Inc. and has received FDA 510(k) clearance under K number K142350. It is manufactured at 136 Tpke. Rd., Southborough, MA 01772.

Other devices from Gyrus Acmi, Inc.

See all devices from Gyrus Acmi, Inc. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PK J-HOOK used for?

    The PK J-HOOK is a surgical device used in general and plastic surgery procedures, as stated in its description. It is designed for tissue manipulation and dissection during these types of operations, based on its substantial equivalence to predicate devices used in similar surgical contexts.

  • How is the PK J-HOOK supplied or distributed?

    The PK J-HOOK is distributed by Gyrus Acmi, Inc., the manufacturer listed in the device data. It is manufactured at their facility in Southborough, MA, and made available through their distribution channels for use in surgical settings.

  • What regulatory pathway was used for the PK J-HOOK?

    The PK J-HOOK received FDA 510(k) clearance under K number K142350, as indicated in the AUTHORIZATIONS and specifications fields. This means it was found substantially equivalent to a legally marketed predicate device, specifically the Gyrus ACMI Plasmacision and Plasmablend electrodes (K050460).