Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biodynamic Technologies, Inc. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
329 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990436 | ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1999-03-31 | 48 | 0 |
| K990513 | ULTIMAX CORTICAL BONE SCREWS | Biodynamic Technologies, Inc. | 1999-03-17 | 27 | 0 |
| K990481 | ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM | Biodynamic Technologies, Inc. | 1999-03-17 | 29 | 0 |
| K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1998-06-01 | 59 | 0 |
| K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1998-04-03 | 81 | 0 |
| K974756 | BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS | Biodynamic Technologies, Inc. | 1998-03-12 | 83 | 0 |
| K972403 | BTI CORTICAL BONE SCREWS | Biodynamic Technologies, Inc. | 1997-08-29 | 64 | 0 |
| K970897 | BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1997-04-21 | 41 | 0 |
| K962706 | EZ-FIX CANNULATED SCREW SYSTEM | Biodynamic Technologies, Inc. | 1996-11-13 | 124 | 0 |
| K962987 | EZ-FIX SMALL CANNULATED SCREW SYSTEM | Biodynamic Technologies, Inc. | 1996-11-04 | 95 | 0 |
| K962846 | EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM | Biodynamic Technologies, Inc. | 1996-10-23 | 93 | 0 |
| K962552 | EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1996-09-25 | 86 | 0 |
| K962553 | EZ-FIX MIDSHAFT HUMERAL INTRAMEDULLARY ROD SYSTEM | Biodynamic Technologies, Inc. | 1996-08-28 | 58 | 0 |
| K954838 | EZ FIX | Biodynamic Technologies, Inc. | 1996-01-24 | 96 | 0 |
| K935593 | ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM | Biodynamic Technologies, Inc. | 1994-10-14 | 329 | 0 |
| K932918 | TOTAL KNEE KIT | Biodynamic Technologies, Inc. | 1994-09-01 | 443 | 0 |
| K926216 | BONE CEMENT RESTRICTOR | Biodynamic Technologies, Inc. | 1994-03-22 | 467 | 0 |
| K935646 | FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM | Biodynamic Technologies, Inc. | 1994-03-09 | 106 | 0 |
| K931540 | UNIVERSAL BONE CEMENT KIT | Biodynamic Technologies, Inc. | 1994-01-27 | 304 | 0 |
| K924323 | THE UNIVERSAL BONE CEMENT RESISTOR | Biodynamic Technologies, Inc. | 1993-02-12 | 169 | 0 |
| K915259 | FX-CABLELOK SYSTEM, MODIFICATION | Biodynamic Technologies, Inc. | 1992-02-07 | 80 | 0 |
| K912207 | FX-CABLELOK SYSTEM | Biodynamic Technologies, Inc. | 1991-07-09 | 50 | 0 |
| K870402 | MOBILIMB HAND EXERCISER | Biodynamic Technologies, Inc. | 1987-03-16 | 42 | 0 |
| K870349 | BIODYNAMICS FEMORAL CANAL BRUSH #1201 | Biodynamic Technologies, Inc. | 1987-02-13 | 16 | 0 |
| K870333 | BIODYNAMICS SMALL JOINT BRUSH #1203 | Biodynamic Technologies, Inc. | 1987-02-13 | 16 | 0 |
| K870329 | ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 | Biodynamic Technologies, Inc. | 1987-02-13 | 16 | 0 |
| K861164 | OSTEOMILL BONE GRINDER | Biodynamic Technologies, Inc. | 1986-05-02 | 35 | 0 |
| K851205 | CEMENTRIFUGE | Biodynamic Technologies, Inc. | 1985-07-16 | 112 | 0 |
| K851177 | UNIVERSAL POWER FLEX | Biodynamic Technologies, Inc. | 1985-06-28 | 95 | 0 |
| K851206 | SHOULDER-HOLDER | Biodynamic Technologies, Inc. | 1985-04-25 | 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