← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

This type of device is designed to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
ImplantLife-sustainingGMP-exemptThird-party review eligible
2
510(K)/PMA CLEARANCES
pma: 2
0
RECALL ENTRIES

Recent clearances

P830055Depuy, Inc. · pma2026-07-15
P060037Zimmer, Inc. · pma2026-01-16

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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