Consulting Wallah › Device Explorer › Orthopaedic implants › Joint prosthesis implantation kit, reusable
Device Explorer · FDA GUDID · GMDN 44742

Joint prosthesis implantation kit, reusable

A collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cuttin

US‑registered devices16,641in commercial distribution
Companies44labelers on GUDID
Single‑use34%of device records
Sterile2%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Microport Orthopedics Inc.13,17479%
Omni Life Science, Inc.5974%
Zimmer Gmbh4343%
Smith & Nephew, Inc.3162%
Restor3D, Inc.3022%
Engage Uni Llc3022%
Kyocera Medical Corporation2121%
Kyocera Corporation2121%

Top labelers

CompanyDevicesShare
Microport Orthopedics Inc.13,17479%
Omni Life Science, Inc.5974%
Zimmer Gmbh4343%
Smith & Nephew, Inc.3162%
Restor3D, Inc.3022%
Engage Uni Llc3022%
Kyocera Medical Corporation2121%
Kyocera Corporation2121%
Optimotion Implants Llc1761%
Novosource, Llc1691%
Ascension Orthopedics, Inc.1221%
Cpm Medical Consultants, Llc1211%

Company = labeler of record on GUDID. 44 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Patient-Fitted TMJ Reconstructive Prosthesis SysVARIAXTC-PLUSPIGALILEOendophixOsteotec SFI InstrumentsRECAP HIP INSTRUMENTATIONRECAP/MAGNUM HIP INSTRUMENTATIONInitia Total Hip SystemAGILON®Ankle clampAGILON® XO glenosphere countering instrumentAGILON® XO GoniometerN/AACHIEVECASBIRMINGHAM HIP RESURFACING (BHR)

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

FDA product codes

CodeNameDevices
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM4,778
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN4,759
HWTTEMPLATE4,251
OOGKnee arthroplasty implantation system3,695
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem1,099
FZXGuide, surgical, instrument949

GMDN & GCC registration

  • GMDN code 44742 · non‑implantable
  • Single‑use 34% · sterile 2% · Rx‑only 95% · 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) · 127Length (Millimeter) · 26Angle (degree) · 8Length (Centimeter) · 2

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

How many joint prosthesis implantation kit, reusable products are registered in the US?

16,641 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Joint prosthesis implantation kit, reusable", from 44 companies. The largest labeler is Microport Orthopedics Inc. with 79% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), HWT (TEMPLATE), OOG (Knee arthroplasty implantation system)

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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