Consulting Wallah › Device Explorer › Orthopaedic implants › Partial-resurfacing knee femur prosthesis
Device Explorer · FDA GUDID · GMDN 58992

Partial-resurfacing knee femur prosthesis

A sterile implantable device, in the form of a small plug and stem, designed to treat focal lesions of the articular surface of the distal femur by excision of the lesion and uncemented fixation of the device in the surgically-prepared defect, with retention o

US‑registered devices80in commercial distribution
Companies1labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Arthrosurface Incorporated80100%

Top labelers

CompanyDevicesShare
Arthrosurface Incorporated80100%

Company = labeler of record on GUDID. 1 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

HemiCAPWAVE®WaveKahuna™HemiCAP®

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

FDA product codes

CodeNameDevices
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemente80

GMDN & GCC registration

  • GMDN code 58992 · 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

Outer Diameter (Millimeter) · 56

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

How many partial-resurfacing knee femur prosthesis products are registered in the US?

80 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Partial-resurfacing knee femur prosthesis", from 1 companies. The largest labeler is Arthrosurface Incorporated with 100% of records.

Which FDA product codes apply?

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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