Atlas FDA

KYJ

14 FDA 510(k) clearances · Product code

194 daysmedian time to decision
441 days90th percentile
14clearances measured

FDA profile

Official device name
Prosthesis, Finger, Constrained, Polymer
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3230
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2021: 45 · 2022: 39 · 2023: 24 · 2024: 29 · 2025: 33 · 2026: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Ascension Silicone MCP; Ascension Silicone PIP (K233670)Ascension Orthopedics, Inc.2023-12-14
BRM Digitalis Spacer (K220142)Brm Extremities Srl2023-04-04
KeriFlex® MCP and PIP Finger Joint Prostheses (K211385)Keri Medical SA2022-07-27
OSTEOTEC SILICONE FINGER IMPLANT (K140453)Osteotec, Ltd.2015-04-17
MODIFICATION TO DEPUY NEUFLEX PIP FINGER (K083107)DePuy Orthopaedics, Inc.2009-02-09
ASCENSION SILICONE PIP (K082231)Ascension Orthopedics, Inc.2009-01-12
ASCENSION SILLICONE MCP (K022892)Ascension Orthopedics, Inc.2002-11-25
FINGER JOINT PROSTHESIS (K013629)Avanta Orthopaedics, Inc.2002-01-25
DEPUY NEUFLEX PIP FINGER (K001922)Depuy, Inc.2000-08-29
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (K970544)Depuy, Inc.1997-09-12
SUTTER PROXIMAL INTERPHALANGEAL JOINT (K931588)Sutter Corp.1994-03-10
SUTTER FINGER JOINT PROSTHESIS (K870200)Sutter Biomedical, Inc.1987-10-09
MARNE M.T.P.J. ORTHOPEDIC IMPLANT (K781380)Farah , Ltd.1979-02-21
GAMMA RADIATION STERILIZATION PRECEDURE (K781668)Cutter Laboratories, Inc.1978-11-03

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Every clearance here is in the API, with alerts when new ones post.