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Device Explorer · FDA GUDID · GMDN 32856

Orthopaedic implant impactor, reusable

A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It com

US‑registered devices3,893in commercial distribution
Companies156labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription79%Rx‑only share
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Share of device records

Smith & Nephew, Inc.70018%
Arthrex, Inc.2897%
Biomet Orthopedics, Llc2617%
Enztec Limited1313%
Exactech, Inc.1173%
Depuy (Ireland)1103%
Howmedica Osteonics Corp.862%
United Orthopedic Corp.812%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.70018%
Arthrex, Inc.2897%
Biomet Orthopedics, Llc2617%
Enztec Limited1313%
Exactech, Inc.1173%
Depuy (Ireland)1103%
Howmedica Osteonics Corp.862%
United Orthopedic Corp.812%
Ortho Development Corporation812%
Synthes Gmbh762%
Medtronic Sofamor Danek, Inc.722%
Corin Ltd692%

Company = labeler of record on GUDID. 156 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/AINSTRUMENTInstrumentAVSVLIFTXIA 3XIA 4.5O.I.C. TITANIUMEASYSTEPREUNIONT2NAGAMMAPOLARCUPPOLARSTEMPROMOS

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HWAIMPACTOR1,288
HWAImpactor636
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT439
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented287
LXHOrthopedic Manual Surgical Instrument176
LXHOrthopedic manual surgical instrument171

GMDN & GCC registration

  • GMDN code 32856 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 79% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 56Length (Inch) · 37Width (Millimeter) · 18Length (Centimeter) · 16Lumen/Inner Diameter (Millimeter) · 14Length (Millimeter) · 11

Use these as the dimensions to specify in a tender line.

How many orthopaedic implant impactor, reusable products are registered in the US?

3,893 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant impactor, reusable", from 156 companies. The largest labeler is Smith & Nephew, Inc. with 18% of records.

Which FDA product codes apply?

HWA (IMPACTOR), HWA (Impactor), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), JDI (Prosthesis, hip, semi-constrained, metal/polymer, cemented)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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