Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LXT · Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
128 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230067 | Para-Fix External Fixation System | New Paradigm Biomedical | 2023-09-22 | 256 | 0 |
| K131636 | POLARUS CONNECT | Acumed, LLC | 2013-10-10 | 128 | 0 |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR | Biomet | 2013-10-09 | 41 | 1 |
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | Medos International SARL | 2011-10-31 | 77 | 2 |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S | DePuy Orthopaedics, Inc. | 2009-03-11 | 22 | 0 |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | 2008-01-29 | 83 | 0 |
| K063832 | SYNTHES (USA) ELBOW HINGE FIXATOR | Synthes (Usa) | 2007-03-07 | 71 | 0 |
| K060864 | MULTIDIRECTIONAL THREADED PEG | Hand Innovations, LLC | 2006-04-28 | 29 | 0 |
| K060403 | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | Meridian Medical | 2006-03-28 | 41 | 0 |
| K060290 | SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2006-02-27 | 21 | 0 |
| K052754 | WRIST FUSION PLATE | Dvo Extremity Solutions, LLC | 2005-10-27 | 27 | 0 |
| K051728 | MODIFICATION TO SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2005-07-20 | 23 | 0 |
| K051306 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-06-17 | 29 | 0 |
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | 2005-04-26 | 12 | 1 |
| K050631 | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | Synthes (Usa) | 2005-04-11 | 31 | 0 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION | A.M. Surgical, Inc. | 2004-10-07 | 27 | 0 |
| K042059 | SHOULDER FIXATION SYSTEM | Hand Innovations, Inc. | 2004-09-30 | 62 | 0 |
| K033805 | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | Synthes (Usa) | 2004-02-20 | 74 | 0 |
| K033145 | HOFFMANN II PELVIC CLAMP | Howmedica Osteonics Corp. | 2003-11-05 | 36 | 0 |
| K032705 | DISTAL RADIUS FRACTURE REPAIR SYSTEM | Hand Innovations, Inc. | 2003-10-01 | 29 | 0 |
| K032169 | CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HA | Cyberorthology, Inc. | 2003-09-22 | 68 | 0 |
| K031973 | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR | Synthes (Usa) | 2003-09-05 | 71 | 0 |
| K031428 | SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE | Synthes (Usa) | 2003-08-08 | 94 | 1 |
| K031959 | STRYKER PLATING SYSTEM PERIARTICULAR PLATES | Howmedica Osteonics Corp. | 2003-07-25 | 30 | 0 |
| K030390 | SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR S | Synthes (Usa) | 2003-04-01 | 55 | 2 |
| K022651 | HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT | Howmedica Osteonics Corp. | 2002-10-17 | 69 | 0 |
| K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | Biomet Orthopedics, Inc. | 2002-04-15 | 26 | 0 |
| K013739 | MODIFICATION TO EBI XFIX DFS SYSTEM | Ebi, L.P. | 2001-12-13 | 30 | 0 |
| K013772 | MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM | Howmedica Osteonics | 2001-12-03 | 20 | 0 |
| K011948 | HOFFMAN II HYBRID RING CLAMP | Howmedica Osteonics Corp. | 2001-07-13 | 22 | 0 |
| K003240 | BIOMET EXTERNAL WRIST PLATE | Biomet, Inc. | 2000-12-29 | 73 | 0 |
| K002923 | DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2000-12-18 | 90 | 0 |
| K003205 | TRANSFX ANGLED RODS | Immedica, Inc. | 2000-12-15 | 63 | 7 |
| K003211 | HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING | Howmedica Osteonics Corp. | 2000-12-15 | 63 | 0 |
| K001760 | RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | 2000-08-31 | 83 | 0 |
| K001793 | SYNTHES SCALLOPED DISTAL TIBIA PLATE | Synthes (Usa) | 2000-08-17 | 64 | 0 |
| K000972 | SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS | Synthes (Usa) | 2000-06-16 | 81 | 0 |
| K001084 | TRANS FX ADJUSTABLE PIN TO BAR CLAMP | Immedica, Inc. | 2000-06-15 | 72 | 0 |
| K000957 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2000-05-23 | 60 | 0 |
| K000558 | SYNTHES (USA) WRIST FUSION PLATES (WFP) | Synthes (Usa) | 2000-04-14 | 56 | 0 |
| K991889 | ULTIMAX HAIG II NAIL SYSTEM | Encore Orthopedics, Inc. | 1999-08-12 | 70 | 0 |
| K991723 | TRANSFX MULTI PIN CLAMP | Immedica, Inc. | 1999-07-22 | 63 | 7 |
| K991407 | SYNTHES LOCKING CALCANEAL PLATES | Synthes (Usa) | 1999-06-11 | 50 | 0 |
| K990848 | TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL | Immedica, Inc. | 1999-05-17 | 63 | 8 |
| K984357 | TRANSFX EXTERNAL FIXATION SYSTEM | Immedica, Inc. | 1999-03-04 | 87 | 7 |
| K974245 | DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG | Depuy Ace Medical Co. | 1998-05-22 | 191 | 0 |
| K963432 | GUIDE WIRES FOR CANNULATED SCREWS | Orthopaedic Biosystems, Ltd. | 1996-11-13 | 75 | 0 |
| K963618 | SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) | Synthes (Usa) | 1996-11-12 | 63 | 0 |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | Biodynamic Technologies, Inc. | 1996-10-23 | 93 | 0 |
| K954053 | BERLIN EXTERNAL FIXATOR | Encore Orthopedics, Inc. | 1996-05-16 | 261 | 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