Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JEC · Predicate Candidate Screening
85 FDA 510(k) clearances under this product code; the 50 most recent screened below.
64 daysmedian FDA review time
232 days90th percentile
85clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203605 | SteriTrak | Arbutus Medical, Inc. | 2021-04-23 | 134 | 0 |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020-03-02 | 97 | 0 |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019-10-10 | 31 | 0 |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018-10-22 | 171 | 0 |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018-03-19 | 270 | 0 |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Device | Surgical Instrument Service and Savings, Inc. | 2016-12-28 | 58 | 0 |
| K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | 2014-01-10 | 129 | 0 |
| K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 49 | Stryker Corp. | 2011-01-14 | 106 | 0 |
| K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | 2009-04-07 | 204 | 0 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NO | Hand Biomechanics Lab, Inc. | 2008-01-09 | 133 | 0 |
| K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | 2007-08-24 | 87 | 0 |
| K042066 | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | 2004-08-25 | 23 | 0 |
| K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | 2003-10-09 | 64 | 0 |
| K031941 | HOFFMANN II COMPACT BALTIMORE COUPLING | Howmedica Osteonics Corp. | 2003-07-24 | 30 | 0 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, | Hand Biomechanics Lab, Inc. | 2003-06-10 | 111 | 0 |
| K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | 2002-09-23 | 42 | 0 |
| K022065 | SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X | Sintea Biotech, Inc. | 2002-08-06 | 42 | 0 |
| K012193 | AMC ANTIMICROBIAL PIN/WIRE SLEEVE | Smith & Nephew, Inc. | 2002-07-11 | 364 | 0 |
| K013818 | AUTOGENESIS AUTOMATOR, MODEL M1000 | Autogenesis, Inc. | 2001-12-05 | 19 | 0 |
| K003848 | HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST | Howmedica Osteonics Corp. | 2001-01-11 | 30 | 0 |
| K993099 | BREMER HALO SYSTEM TITANIUM SKULL PIN | Depuyacromed | 1999-12-15 | 90 | 15 |
| K991732 | CENTRAFIX EXTERNAL FIXATOR | Owandar Medical, Ltd. | 1999-05-21 | 0 | 0 |
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), M | Hand Biomechanics Lab, Inc. | 1999-02-12 | 60 | 0 |
| K981423 | AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 | Autogenesis, Inc. | 1998-05-20 | 30 | 0 |
| K971755 | HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1997-07-17 | 66 | 1 |
| K965029 | STABLELOC II EXTERNAL FIXATOR | Acu Med, Inc. | 1997-02-19 | 64 | 1 |
| K963614 | MONOTUBE CARBON TUBE | Howmedica Corp. | 1996-11-06 | 57 | 0 |
| K961916 | HOFFMANN II CARBON CONNECTING ROD | Howmedica, Inc. | 1996-08-01 | 76 | 0 |
| K961618 | MONOTUBE TUBE TO RING CLAMP | Howmedica Corp. | 1996-05-28 | 32 | 0 |
| K960782 | TITANIUM TUBE TO TUBE CLAMP | Synthes (Usa) | 1996-05-08 | 72 | 0 |
| K954838 | EZ FIX | Biodynamic Technologies, Inc. | 1996-01-24 | 96 | 0 |
| K954667 | MONOTUBE TUBE-TO-TUBE CLAMP | Howmedica Corp. | 1996-01-11 | 93 | 0 |
| K952330 | EXTERNAL FIXATOR | Acu Med, Inc. | 1995-10-05 | 140 | 0 |
| K952730 | HOFFMANN II EXTERNAL FIXATION SYSTEM | Howmedica Corp. | 1995-09-08 | 85 | 0 |
| K944092 | ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM | Orthofix Srl | 1995-04-04 | 225 | 0 |
| K943857 | EXTERNAL FIXATOR | Acu Med, Inc. | 1995-01-27 | 172 | 0 |
| K933968 | ACE PELVIC STABILIZER | Ace Medical Co. | 1994-06-16 | 304 | 0 |
| K922796 | PELVIC C-CLAMP | Synthes (Usa) | 1994-03-10 | 639 | 0 |
| K936124 | HOWMEDICA MONOTUBE T-CONNECTOR | Howmedica, Inc. | 1994-02-22 | 61 | 0 |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | Applied Osteo Systems, Inc. | 1994-02-22 | 329 | 0 |
| K936045 | ACE UNILATERAL FIXATOR II | Ace Orthopedic Manufacturing Co. | 1994-02-22 | 64 | 0 |
| K934698 | HOWMEDICA MONO-TUBE SINGLE PIN CLAMP | Howmedica Corp. | 1994-02-22 | 145 | 0 |
| K930153 | SYSTEM III HALO RING | Jerome Medical | 1993-08-06 | 206 | 0 |
| K920117 | HALO ESPRIT | Itm Corp. | 1992-10-06 | 267 | 0 |
| K920149 | OSTEO EX-FI-RE | Osteo AG | 1992-04-09 | 90 | 0 |
| K915800 | BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN | Bremer Medical, Inc. | 1992-03-16 | 83 | 15 |
| K914858 | ACE OPEN-BACK HALO RING | Ace Medical Co. | 1991-11-21 | 23 | 0 |
| K894959 | CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO | Alphatec Mfg., Inc. | 1990-09-14 | 403 | 0 |
| K903105 | OLIVE K-WIRES | Danek Medical, Inc. | 1990-09-06 | 63 | 0 |
| K901984 | ACE WIRE TENSION CLAMP | Buckman Co., Inc. | 1990-06-21 | 50 | 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