Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho Development Corp. — Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
204 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 | 84 | 0 |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 | 49 | 0 |
| K242984 | BKS Revision System | Ortho Development Corp. | 2024-10-25 | 29 | 0 |
| K242833 | Legend® Acetabular Shell | Ortho Development Corp. | 2024-10-11 | 22 | 0 |
| K233758 | Trivicta™ Hip Stem | Ortho Development Corp. | 2024-03-08 | 105 | 0 |
| K142146 | IBIS PEDICLE SCREW SYSTEM | Ortho Development Corp. | 2014-12-11 | 128 | 0 |
| K132697 | ENCOMPASS 10/12 HIP STEM | Ortho Development Corp. | 2014-06-20 | 295 | 0 |
| K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | Ortho Development Corp. | 2014-03-11 | 126 | 0 |
| K133449 | KASM KNEE ARTICULATING SPACER MOLDS | Ortho Development Corp. | 2014-02-18 | 98 | 0 |
| K131022 | OVATION 10/12 HIP STEM | Ortho Development Corp. | 2013-10-16 | 187 | 0 |
| K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AN | Ortho Development Corp. | 2013-10-11 | 155 | 0 |
| K131785 | PAGODA PEDICLE SCREW SYSTEM | Ortho Development Corp. | 2013-08-20 | 63 | 0 |
| K122588 | VUSION CS PLUS | Ortho Development Corp. | 2013-06-12 | 292 | 0 |
| K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS | Ortho Development Corp. | 2013-03-22 | 134 | 0 |
| K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT | Ortho Development Corp. | 2009-10-09 | 206 | 1 |
| K062171 | EMF PAL II MAIN GENERATOR AND IRRIGATION UNITS AND ACCESSORI | Ortho Development Corp. | 2007-05-25 | 298 | 0 |
| K062666 | VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS | Ortho Development Corp. | 2007-01-25 | 140 | 0 |
| K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM | Ortho Development Corp. | 2007-01-16 | 120 | 4 |
| K061524 | ISS INTEGRATED SPINE SYSTEM | Ortho Development Corp. | 2006-09-26 | 116 | 0 |
| K060569 | BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM | Ortho Development Corp. | 2006-07-06 | 125 | 1 |
| K060577 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS | Ortho Development Corp. | 2006-04-28 | 53 | 0 |
| K053587 | ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS | Ortho Development Corp. | 2006-03-17 | 84 | 0 |
| K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS | Ortho Development Corp. | 2006-02-16 | 83 | 2 |
| K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HE | Ortho Development Corp. | 2005-09-23 | 196 | 0 |
| K051407 | LEGEND ALL-POLY CUP | Ortho Development Corp. | 2005-09-08 | 100 | 0 |
| K050966 | PIVOT BIPOLAR FEMORAL HEAD | Ortho Development Corp. | 2005-07-07 | 80 | 2 |
| K042565 | ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM | Ortho Development Corp. | 2005-04-11 | 202 | 0 |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | 2005-01-27 | 91 | 0 |
| K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM | Ortho Development Corp. | 2003-07-15 | 90 | 2 |
| K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED | Ortho Development Corp. | 2002-05-06 | 90 | 0 |
| K020649 | ENVISION ANTERIOR CERVICAL PLATE SYSTEM | Ortho Development Corp. | 2002-04-05 | 36 | 0 |
| K012129 | ORTHO DEVELOPMENT ORION-I EMF SYSTEM | Ortho Development Corp. | 2001-08-22 | 44 | 0 |
| K000321 | HEMISPHERE MODULAR CUP SYSTEM | Ortho Development Corp. | 2000-04-10 | 68 | 0 |
| K994370 | ORTHO DEVELOPMENT BALANCED KNEE SYSTEM | Ortho Development Corp. | 2000-03-24 | 88 | 4 |
| K990986 | CONTOUR SPINAL SYSTEM | Ortho Development Corp. | 1999-10-14 | 204 | 0 |
| K982389 | ODC B2 BIPOLAR CUP | Ortho Development Corp. | 1998-10-07 | 90 | 0 |
| K974158 | ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROT | Ortho Development Corp. | 1997-12-09 | 36 | 0 |
| K970675 | HEADLOC CERAMIC HEAD | Ortho Development Corp. | 1997-08-22 | 179 | 0 |
| K971581 | HEMISPHERE CEMENTED CUP | Ortho Development Corp. | 1997-07-18 | 79 | 0 |
| K971426 | HEADLOC CERAMIC HEAD | Ortho Development Corp. | 1997-07-09 | 83 | 0 |
| K971435 | HEADLOC CERAMIC FEMORAL HEADS | Ortho Development Corp. | 1997-07-09 | 82 | 0 |
| K962448 | PRIMALOC CEMENTED HIP SYSTEM | Ortho Development Corp. | 1996-09-19 | 87 | 2 |
| K961793 | BI-LOC BIPOLAR CUP | Ortho Development Corp. | 1996-07-26 | 78 | 0 |
| K960660 | HEMISPHERE ACETABULAR CUP | Ortho Development Corp. | 1996-05-08 | 82 | 0 |
| K953977 | PRIMALOC CEMENTLESS HIP SYSTEM | Ortho Development Corp. | 1996-01-26 | 156 | 2 |
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