ClearanceBrief
Panels › Orthopedic › Product code HWA · Class 1

Impactor

Regulation 888.4540

0510(k)s in 12 months (4 all time)
2recalls in 12 months (27 all time)
2recalls that name a 510(k)
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Top companies in HWA

DateFirm and productCodeLinked 510(k)
Mar 9, 2026Exactech, Inc.
Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X
Open, Classified
HWANone listed
Mar 9, 2026Exactech, Inc.
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Open, Classified
HWANone listed
Nov 25, 2024INCIPIO DEVICES
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Open, Classified
HWANone listed
Jun 30, 2023Exactech, Inc.
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Open, Classified
HWANone listed
May 12, 2020XTANT Medical
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
Terminated
HWANone listed
Jan 24, 2020Enztec Limited
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Terminated
HWANone listed
Sep 10, 2019Exactech, Inc.
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically,
Terminated
HWANone listed
Aug 28, 2017Zimmer Biomet, Inc.
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compart
Terminated
HWANone listed
Feb 9, 2017Encore Medical, Lp
RSP Impaction Fixture
Terminated
HWANone listed
Feb 9, 2017Encore Medical, Lp
Turon Impaction Fixture
Terminated
HWANone listed
Nov 29, 2016Greatbatch Medical
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CH
Terminated
HWANone listed
Oct 7, 2016Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Terminated
HWAK153345
Sep 14, 2015Encore Medical, Lp
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. Th
Terminated
HWANone listed
Sep 14, 2015Encore Medical, Lp
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is
Terminated
HWANone listed
Nov 24, 2014Zimmer, Inc.
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Terminated
HWANone listed
Nov 24, 2014Zimmer, Inc.
Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Terminated
HWANone listed
Mar 6, 2014Greatbatch Medical
Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391,
Terminated
HWANone listed
Dec 27, 2013Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Terminated
HWANone listed
Dec 27, 2013Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Terminated
HWANone listed
Jun 5, 2013SpineFrontier, Inc.
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion device
Terminated
HWANone listed
Jan 30, 2012DePuy Orthopaedics, Inc.
The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in pol
Terminated
HWANone listed
Aug 27, 2009Stryker Howmedica Osteonics Corp.
Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignm
Terminated
HWANone listed
Oct 20, 2008Stryker Howmedica Osteonics Corp.
Scorpio Series 7000 Tibial Impactor/Extractor, Catalog number 3770-000 Non Sterile Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Impactor/Extractor is used for insertion and remov
Terminated
HWANone listed
Sep 20, 2008Zimmer Inc.
Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile, Zimmer, Warsaw, Indiana; REF 5951-90..
Terminated
HWANone listed
May 14, 2008Stryker Howmedica Osteonics Corp.
Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430
Terminated
HWANone listed
Oct 10, 2007Encore Medical, Lp
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
HWAK020741
K022437
May 29, 2003Stryker Howmedica Osteonics
Trident Insert Impactor
Terminated
HWANone listed

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