KYJ · Class II · 21 CFR 888.3230

FDA Product Code KYJ: Prosthesis, Finger, Constrained, Polymer

Leading manufacturers include Depuy, Inc., Brm Extremities Srl and Ascension Orthopedics, Inc..

14
Total
14
Cleared
206d
Avg days
1978
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Prosthesis, Finger, Constrained, Polymer Devices (Product Code KYJ)

14 devices
1–14 of 14
Cleared Dec 14, 2023
Ascension Silicone MCP
K233670
Ascension Orthopedics, Inc.
Orthopedic · 29d
Cleared Apr 04, 2023
BRM Digitalis Spacer
K220142
Brm Extremities Srl
Orthopedic · 441d
Cleared Jul 27, 2022
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385
Keri Medical SA
Orthopedic · 449d
Cleared Feb 09, 2009
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107
DePuy Orthopaedics, Inc.
Orthopedic · 112d
Cleared Aug 29, 2000
DEPUY NEUFLEX PIP FINGER
K001922
Depuy, Inc.
Orthopedic · 67d
Cleared Sep 12, 1997
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544
Depuy, Inc.
Orthopedic · 212d
Cleared Nov 03, 1978
GAMMA RADIATION STERILIZATION PRECEDURE
K781668
Cutter Laboratories, Inc.
Orthopedic · 36d

About Product Code KYJ - Regulatory Context

510(k) Submission Activity

14 total 510(k) submissions under product code KYJ since 1978, with 14 receiving FDA clearance (average review time: 206 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.