Consulting Wallah › Device Explorer › Other devices › Sleeve femoral/tibial extension, coated
Device Explorer · FDA GUDID · GMDN 61556

Sleeve femoral/tibial extension, coated

A sterile implantable device typically designed to be attached to a revision femoral stem, knee femur prosthesis, femur/tibia shaft prosthesis, or body femoral/tibial extension stem to extend length to make up for bone loss during revision arthroplasty or bone

US‑registered devices238in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Depuy (Ireland)6226%
Limacorporate Spa5121%
Smith & Nephew, Inc.2711%
Signal Medical Corporation2711%
Depuy Orthopaedics, Inc.2711%
Ortho Development Corporation2611%
Exactech, Inc.188%

Top labelers

CompanyDevicesShare
Depuy (Ireland)6226%
Limacorporate Spa5121%
Smith & Nephew, Inc.2711%
Signal Medical Corporation2711%
Depuy Orthopaedics, Inc.2711%
Ortho Development Corporation2611%
Exactech, Inc.188%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

REDAPTBalanced Knee Revision SystemCoated Revision StemOptetrak LogicATTUNES-ROM ZTTS-ROMAMF TT CONESAMF REVISION TT CONES

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, Cem96
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/met73
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC73
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un51
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN43
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM43

GMDN & GCC registration

  • GMDN code 61556 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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) · 36Height (Millimeter) · 30Length (Millimeter) · 18

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

How many sleeve femoral/tibial extension, coated products are registered in the US?

238 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sleeve femoral/tibial extension, coated", from 7 companies. The largest labeler is Depuy (Ireland) with 26% of records.

Which FDA product codes apply?

JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem), MRA (Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/met), LPH (PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNC), MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Un)

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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