Consulting Wallah › Device Explorer › Procedure kits & trays › Knee arthroplasty force sensor balance kit
Device Explorer · FDA GUDID · GMDN 58989

Knee arthroplasty force sensor balance kit

A collection of non-sterile devices intended for use with a knee arthroplasty force sensor to measure forces acting across the joint to facilitate assessment of bone resection lines and size of prosthesis components to be implanted. It is intended to help achi

US‑registered devices60in commercial distribution
Companies3labelers on GUDID
Single‑use8%of device records
Sterile8%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Synvasive Technology, Inc.5083%
Exactech, Inc.712%
Covidien Lp35%

Top labelers

CompanyDevicesShare
Synvasive Technology, Inc.5083%
Exactech, Inc.712%
Covidien Lp35%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NEO CLASSIC™LIBRAeLIBRA®N/ATruliantNewtonNAStratis

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

FDA product codes

CodeNameDevices
LXHOrthopedic Manual Surgical Instrument48
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM8
HWCScrew, fixation, bone3
ONNIntraoperative Orthopedic Joint Assessment Aid2
HWTTemplate1

GMDN & GCC registration

  • GMDN code 58989 · non‑implantable
  • Single‑use 8% · sterile 8% · 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

Height (Millimeter) · 22Length (Millimeter) · 5Width (Millimeter) · 3Outer Diameter (Millimeter) · 1

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

How many knee arthroplasty force sensor balance kit products are registered in the US?

60 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Knee arthroplasty force sensor balance kit", from 3 companies. The largest labeler is Synvasive Technology, Inc. with 83% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), JWH (PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM), HWC (Screw, fixation, bone), ONN (Intraoperative Orthopedic Joint Assessment Aid)

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.

How do I get quotes?

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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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