Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JDW · Predicate Candidate Screening
94 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
144 days90th percentile
94clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, | Biodynamik, Inc. | 2026-02-10 | 32 | 0 |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) System | Meduloc, LLC | 2025-10-29 | 267 | 0 |
| K241357 | XT3 System | Biodynamik, Inc. | 2025-01-22 | 253 | 0 |
| K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022-12-08 | 66 | 0 |
| K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022-02-11 | 60 | 0 |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021-10-05 | 144 | 0 |
| K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021-04-02 | 17 | 0 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020-05-05 | 28 | 0 |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 | 286 | 0 |
| K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019-12-26 | 87 | 0 |
| K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018-10-25 | 76 | 0 |
| K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017-02-13 | 63 | 0 |
| K150661 | ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite | Citieffe S.R.L. | 2015-07-07 | 116 | 0 |
| K132820 | VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AN | Vilex, Inc. | 2014-07-23 | 317 | 0 |
| K140875 | OPTOSSOL COMPRESSION DEVICE SYSTEM | Genossis, LLC | 2014-05-30 | 56 | 0 |
| K131459 | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE | Aap Implantate AG | 2013-10-17 | 150 | 0 |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | Biopro, Inc. | 2013-06-18 | 131 | 0 |
| K120871 | SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATIO | Smith & Nephew, Inc. | 2012-06-07 | 77 | 0 |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | 2011-02-17 | 134 | 0 |
| K102777 | TWISTCUT ENDOSORB SCREWS | Merete Medical GmbH | 2010-12-20 | 87 | 0 |
| K100414 | PROTOE ENDOSORB SMALL HAMMER TOE PIN | Merete Medical GmbH | 2010-07-02 | 136 | 0 |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | Acumed, LLC | 2009-06-16 | 236 | 0 |
| K072710 | NEXFIX COMPRESSION PIN | Nexa Orthopedics, Inc. | 2007-11-08 | 44 | 0 |
| K071540 | SBI TITANIUM THREADED PIN | Small Bone Innovations, Inc. | 2007-08-08 | 64 | 0 |
| K061599 | PIN SCREW | Bk Meditech, Co., Ltd. | 2006-07-26 | 48 | 0 |
| K061493 | APEX PINS | Stryker Howmedica Osteonics | 2006-07-07 | 37 | 0 |
| K061498 | ALLOFIX ANCHOR, 5.0 MM ANCHOR | Musculoskeletal Transplant Foundation | 2006-07-06 | 36 | 1 |
| K053513 | T-PIN | Union Surgical, LLC | 2006-01-13 | 28 | 0 |
| K051740 | TAPERED COMPRESSION PIN | Nexa Orthopedics, Inc. | 2005-09-06 | 70 | 0 |
| K040765 | SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS | Synthes (Usa) | 2004-04-12 | 18 | 0 |
| K033289 | MODIFICATION TO JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | 2004-01-13 | 91 | 0 |
| K032532 | TARAS THREADED FIXATION PIN | Union Surgical, LLC | 2003-10-22 | 68 | 0 |
| K031154 | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X | Sintea Biotech, Inc. | 2003-06-24 | 74 | 0 |
| K030336 | KMEDIC EXTERNAL FIXATION DEVICES | Teleflex Medical Group | 2003-03-06 | 34 | 0 |
| K023921 | JET-X HA COATED HALF PINS | Smith & Nephew, Inc. | 2003-02-05 | 72 | 27 |
| K023134 | JET-X TIN COATED HALF PINS | Smith & Nephew, Inc. | 2002-10-09 | 19 | 0 |
| K021182 | RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR | Biomet, Inc. | 2002-05-13 | 28 | 0 |
| K020097 | STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM | Stryker Endoscopy | 2002-03-15 | 64 | 0 |
| K012270 | STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM | Stryker Endoscopy | 2001-09-28 | 71 | 0 |
| K011875 | MODIFICATION TO THE TAC' PIN | New Deal, S.A. | 2001-09-06 | 83 | 0 |
| K011319 | STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX | Stryker Endoscopy | 2001-07-20 | 80 | 0 |
| K011137 | RESORBABLE HAMMERTOE PIN | Biomet, Inc. | 2001-06-19 | 67 | 0 |
| K011136 | APEX FIXATION PINS | Howmedica Osteonics Corp. | 2001-05-04 | 21 | 0 |
| K002605 | 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW | Synthes (Usa) | 2000-11-20 | 90 | 0 |
| K003294 | BIOMET LATERAL TROCH PLATE | Biomet, Inc. | 2000-11-03 | 14 | 0 |
| K003131 | MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT | Biomet, Inc. | 2000-11-02 | 27 | 0 |
| K001720 | SYNTHES SACRAL BAR SYSTEM | Synthes (Usa) | 2000-08-24 | 79 | 0 |
| K001886 | APEX FIXATION PINS | Howmedica Osteonics Corp. | 2000-07-12 | 21 | 0 |
| K001228 | EXTERNAL FIXATION ANCHOR PIN | Immedica, Inc. | 2000-07-07 | 81 | 0 |
| K994143 | SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) | Smith & Nephew, Inc. | 2000-02-18 | 72 | 19 |
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