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)
Top companies in HWA
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Howmedica Osteonics | 0 | 7 |
| Encore Medical, Lp | 0 | 5 |
| Exactech, Inc. | 0 | 4 |
| Zimmer Inc. | 0 | 3 |
| Greatbatch Medical | 0 | 2 |
| Cedar Surgical, Inc. | 1 | 0 |
| Depuy, Inc. | 1 | 0 |
| DePuy Orthopaedics, Inc. | 0 | 1 |
| Enztec Limited | 0 | 1 |
| INCIPIO DEVICES | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2026 | Exactech, Inc. Brand Name: Equinoxe
Product Name: Equinoxe Core Instrument Kit
Model/Catalog Number: KIT-311X Open, Classified |
HWA | None listed |
| Mar 9, 2026 | Exactech, Inc. Brand Name: Equinoxe Ergo
Product Name: Ergo Modular Impactor Handle
Model/Catalog Number: 321-09-05 Open, Classified |
HWA | None listed |
| Nov 25, 2024 | INCIPIO DEVICES Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. Open, Classified |
HWA | None listed |
| Jun 30, 2023 | Exactech, Inc. Exactech Ergo Impactor Handle, Catalog #321-09-05. Open, Classified |
HWA | None listed |
| May 12, 2020 | XTANT Medical Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 Terminated |
HWA | None listed |
| Jan 24, 2020 | Enztec Limited REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE Terminated |
HWA | None listed |
| Sep 10, 2019 | Exactech, 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 |
HWA | None listed |
| Aug 28, 2017 | Zimmer 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 |
HWA | None listed |
| Feb 9, 2017 | Encore Medical, Lp RSP Impaction Fixture Terminated |
HWA | None listed |
| Feb 9, 2017 | Encore Medical, Lp Turon Impaction Fixture Terminated |
HWA | None listed |
| Nov 29, 2016 | Greatbatch Medical Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #:
Tl0600 ~ MMP3100CHA04
T10491 MIMP3100CHA04
T12230 M2M1P3100CHA04
T15752 ~MMP3100CHA04
T15949 ~MMP3100CHA04
T17238 MMP3100CH Terminated |
HWA | None listed |
| Oct 7, 2016 | Stryker 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 |
HWA | K153345 |
| Sep 14, 2015 | Encore 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 |
HWA | None listed |
| Sep 14, 2015 | Encore 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 |
HWA | None listed |
| Nov 24, 2014 | Zimmer, 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 |
HWA | None listed |
| Nov 24, 2014 | Zimmer, 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 |
HWA | None listed |
| Mar 6, 2014 | Greatbatch 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 |
HWA | None listed |
| Dec 27, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Ball Impactor Tip
Product Usage: Used for ADM Surgery. Terminated |
HWA | None listed |
| Dec 27, 2013 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Rim Impactor Tip
Product Usage: Used for MDM surgery. Terminated |
HWA | None listed |
| Jun 5, 2013 | SpineFrontier, 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 |
HWA | None listed |
| Jan 30, 2012 | DePuy 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 |
HWA | None listed |
| Aug 27, 2009 | Stryker 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 |
HWA | None listed |
| Oct 20, 2008 | Stryker 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 |
HWA | None listed |
| Sep 20, 2008 | Zimmer 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 |
HWA | None listed |
| May 14, 2008 | Stryker 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 |
HWA | None listed |
| Oct 10, 2007 | Encore 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 |
HWA | K020741 K022437 |
| May 29, 2003 | Stryker Howmedica Osteonics Trident Insert Impactor Terminated |
HWA | None listed |
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