510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NJDClass II

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

21 CFR 888.3535 / Orthopedic
FDA source (opens on fda.gov)

NJD is the FDA product code for Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer, a class II device type, regulated under 21 CFR 888.3535. FDA's definition for this code reads: "Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NJD
Device name
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
FDA definition
Intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as uni-compartmental osteoarthritis; inflammatory arthritis; traumatic arthritis; varus, valgus or flexion deformities; and revision surgery.
Regulation
21 CFR 888.3535
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code NJD

By decision year
5 clearances under product code NJD with a decision year between 2014 and 2025, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJD by decision year
YearClearances
20141
20191
20221
20241
20251

Applicants with the most clearances

Product code NJD
Applicants holding the most 510(k) clearances under product code NJD
ApplicantClearances
Ignite Orthomotion2
Engage Uni, LLC1
Mako Surgical Corp.1
Smith+Nephew1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order