KYJ · Class II · 21 CFR 888.3230

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

Leading manufacturers include Ascension Orthopedics, Inc., Depuy, Inc. and Keri Medical SA.

15
Total
15
Cleared
195d
Avg days
1978
Since
Declining activity - 1 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 29d recently vs 206d historically

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

15 devices
1–15 of 15
Cleared Oct 29, 2026
KeriFlex® MCP and PIP Finger Joint Prostheses
K263582
Keri Medical SA
Orthopedic · 29d
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 Apr 17, 2015
OSTEOTEC SILICONE FINGER IMPLANT
K140453
Osteotec, Ltd.
Orthopedic · 417d
Cleared Feb 09, 2009
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107
DePuy Orthopaedics, Inc.
Orthopedic · 112d
Cleared Jan 12, 2009
ASCENSION SILICONE PIP
K082231
Ascension Orthopedics, Inc.
Orthopedic · 158d
Cleared Nov 25, 2002
ASCENSION SILLICONE MCP
K022892
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Jan 25, 2002
FINGER JOINT PROSTHESIS
K013629
Avanta Orthopaedics, Inc.
Orthopedic · 81d
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 Mar 10, 1994
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K931588
Sutter Corp.
Orthopedic · 344d
Cleared Oct 09, 1987
SUTTER FINGER JOINT PROSTHESIS
K870200
Sutter Biomedical, Inc.
Orthopedic · 262d
Cleared Feb 21, 1979
MARNE M.T.P.J. ORTHOPEDIC IMPLANT
K781380
Farah , Ltd.
Orthopedic · 194d
Cleared Nov 03, 1978
GAMMA RADIATION STERILIZATION PRECEDURE
K781668
Cutter Laboratories, Inc.
Orthopedic · 36d

About Product Code KYJ - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code KYJ since 1978, with 15 receiving FDA clearance (average review time: 195 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - KYJ Product Code

Recent submissions under KYJ have taken an average of 29 days to reach a decision - down from 206 days historically, suggesting improved FDA processing for this classification.

KYJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →