Prosthesis, Ankle, Uncemented, Non-Constrained

NTG · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: NTG
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: OR
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

Definition

An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 19

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown