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Device Explorer · FDA GUDID · GMDN 34192

Metal-backed patella prosthesis

An implantable device covered with metal on its outer surface intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral compo

US‑registered devices68in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile100%labelled sterile
Prescription91%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Depuy (Ireland)1928%
Howmedica Osteonics Corp.1421%
Zimmer, Inc.1319%
Zimmer Trabecular Metal Technology Inc.913%
Encore Medical, L.P.69%
Biomet Orthopedics, Llc69%
Corin Ltd11%

Top labelers

CompanyDevicesShare
Depuy (Ireland)1928%
Howmedica Osteonics Corp.1421%
Zimmer, Inc.1319%
Zimmer Trabecular Metal Technology Inc.913%
Encore Medical, L.P.69%
Biomet Orthopedics, Llc69%
Corin Ltd11%

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

Brand names on the register (sample)

TriathlonDuraconPlasma Coated NTK SystemPersona® The Personalized Knee® OsseoTi®Gender Solutions® Natural-Knee®NEXGEN® TRABECULAR METAL®NEXGEN® TRABECULAR METAL™NEXGEN®DJO SURGICALBiomet® Patellar SystemBIOMET PATELLAR SYSTEMATTUNE AOX AFFIXIUMLCS COMPLETE

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, CEM56
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN47
NJLProsthesis, knee, patellofemorotibial, semi-constrained, met25
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cem15
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL9
MBVProsthesis, knee, patello/femorotibial, semi-constrained, uh6

GMDN & GCC registration

  • GMDN code 34192 · implantable
  • Single‑use 99% · sterile 100% · Rx‑only 91% · 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

No structured size data on the register.

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

How many metal-backed patella prosthesis products are registered in the US?

68 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Metal-backed patella prosthesis", from 7 companies. The largest labeler is Depuy (Ireland) with 28% of records.

Which FDA product codes apply?

JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), MBH (PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UN), NJL (Prosthesis, knee, patellofemorotibial, semi-constrained, met), OIY (Prosthesis, knee, patellofemorotibial, semi-constrained, cem)

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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