Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KYI — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
88 daysmedian FDA review time
331 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC | Ensemble Orthopedics, LLC | 2020-12-02 | 224 | 0 |
| K180744 | Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC | 2018-04-11 | 20 | 0 |
| K111068 | STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND | Skeletal Dynamics, LLC | 2011-12-30 | 256 | 0 |
| K112278 | ASCENSION NUGRIP CMC IMPLANT | Ascension Orthopedic | 2011-11-04 | 87 | 0 |
| K092548 | EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS | Extremity Medical, LLC | 2009-12-15 | 118 | 0 |
| K061956 | ARTELON STT SPACER | Artimplant AB | 2007-06-07 | 331 | 0 |
| K061954 | ARTELON CMC SPACER ARTHRO | Artimplant AB | 2007-06-01 | 325 | 0 |
| K061451 | ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-4 | Ascension Orthopedics, Inc. | 2006-08-11 | 78 | 1 |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17 | Biopro, Inc. | 2006-06-20 | 63 | 0 |
| K060386 | NEXA CARPO METACARPAL IMPLANT | Nexa Orthopedics, Inc. | 2006-05-10 | 85 | 0 |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199, | Biopro, Inc. | 2005-11-15 | 55 | 0 |
| K042690 | ASCENSION PYROSPHERE (PCS) | Ascension Orthopedics, Inc. | 2004-11-13 | 45 | 0 |
| K040070 | ARTELON SPACER CMC-1 | Artimplant AB | 2004-09-21 | 251 | 0 |
| K041451 | ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS | Ascension Orthopedics, Inc. | 2004-08-25 | 85 | 2 |
| K033529 | TIE-IN TRAPEZIUM | Wrightmedicaltechnologyinc | 2003-12-03 | 23 | 0 |
| K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | Avanta Orthopaedics, Inc. | 1997-06-03 | 159 | 0 |
| K960534 | METALLIC SPHERICAL CMC IMPLANT | Wrightmedicaltechnologyinc | 1997-02-06 | 365 | 0 |
| K960659 | CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL | Wrightmedicaltechnologyinc | 1997-02-06 | 356 | 0 |
| K964472 | RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT | Biologically Oriented Prostheses | 1997-02-03 | 88 | 0 |
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | Avanta Orthopaedics, Inc. | 1997-01-22 | 79 | 1 |
| K951471 | STRICKLAND TRAPEZIAL IMPLANT | Wrightmedicaltechnologyinc | 1995-08-09 | 132 | 0 |
| K864488 | SWANSON TITANIUM CONDYLAR IMPLANT | Dow Corning Wright | 1987-04-15 | 153 | 0 |
| K864489 | SWANSON TITANIUM TRAPEZIUM IMPLANT | Dow Corning Wright | 1987-04-15 | 153 | 0 |
| K801952 | SPINE ALIGN | B.H. Richardson, D.C. | 1980-09-16 | 29 | 0 |
| K790508 | TRAPEZIO-METACARPAL JOINT SPACER | Scientific Data Systems Israel, Ltd. | 1979-04-10 | 32 | 0 |
| K781756 | SILASTIC H.P. TRAPEXIAL IMPLANT | Dow Corning Corp. Healthcare Industries Materials | 1978-11-15 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda