Consulting Wallah › Device Explorer › Orthopaedic implants › Joint prosthesis implantation kit, single-use
Device Explorer · FDA GUDID · GMDN 61781

Joint prosthesis implantation kit, single-use

A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, sa

US‑registered devices480in commercial distribution
Companies13labelers on GUDID
Single‑use97%of device records
Sterile96%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Conformis, Inc.29561%
Episurf Operations Ab4710%
Packroom Llc296%
Depuy (Ireland)296%
Restor3D, Inc.255%
Fusion Orthopedics, Llc153%
Arthrosurface Incorporated112%
Overture Resurfacing Inc102%

Top labelers

CompanyDevicesShare
Conformis, Inc.29561%
Episurf Operations Ab4710%
Packroom Llc296%
Depuy (Ireland)296%
Restor3D, Inc.255%
Fusion Orthopedics, Llc153%
Arthrosurface Incorporated112%
Overture Resurfacing Inc102%
Total Joint Orthopedics, Inc.71%
Ortho Solutions Holdings Limited51%
Medshape, Inc.41%
Ascension Orthopedics, Inc.20%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OXFORD ANKLE FUSION NAIL (AFN) SYSTEMORTHO SOLUTIONS SUCCESSION AFN SYSTEMOXFORD ANKLE FUSION NAIL(AFN) SYSTEMHammerTechKinos InstrumentationKinos Axiom Instrumentationrestor3d Kinos Axiom InstrumentationGuide Pin, Triangle HeadFluted Pin, Square Head, 89mmScrew Pin, Hex Head, 50mmScrew Pin, Hex Head, 33mmDrill and Pin Set, ScrewDrill and Pin Set, SharpDrill and Pin Set, SmoothNEGA Total Joint *RFID PBWellstar Total Joint

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, Cem291
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem291
OOGKnee Arthroplasty Implantation System291
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemente47
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer26
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT25

GMDN & GCC registration

  • GMDN code 61781 · non‑implantable
  • Single‑use 97% · sterile 96% · Rx‑only 87% · 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

Width (Millimeter) · 9Length (Millimeter) · 3

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

How many joint prosthesis implantation kit, single-use products are registered in the US?

480 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Joint prosthesis implantation kit, single-use", from 13 companies. The largest labeler is Conformis, Inc. with 61% of records.

Which FDA product codes apply?

JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), OIY (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), OOG (Knee Arthroplasty Implantation System), KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemente)

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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