Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Disc-O-Tech Medical Technologies, Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
205 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071375 | MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-21 | 219 | 0 |
| K071679 | METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS | Disc-O-Tech Medical Technologies, Ltd. | 2007-12-17 | 181 | 0 |
| K063067 | CONFIDENCE FENESTRATED INTRODUCER NEEDLE | Disc-O-Tech Medical Technologies, Ltd. | 2006-11-03 | 28 | 0 |
| K062424 | CONFIDENCE EX HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | 2006-09-14 | 27 | 0 |
| K060300 | CONFIDENCE HIGH VISCOSITY BONE CEMENT | Disc-O-Tech Medical Technologies, Ltd. | 2006-06-21 | 135 | 7 |
| K040612 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2004-06-17 | 101 | 0 |
| K040939 | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2004-05-12 | 30 | 0 |
| K032730 | FIXION HIP SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2004-03-26 | 205 | 0 |
| K034037 | SKY BONE EXPANDER SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2004-01-28 | 30 | 0 |
| K032358 | B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) | Disc-O-Tech Medical Technologies, Ltd. | 2003-12-17 | 140 | 0 |
| K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | Disc-O-Tech Medical Technologies, Ltd. | 2003-05-30 | 63 | 0 |
| K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) | Disc-O-Tech Medical Technologies, Ltd. | 2002-03-08 | 88 | 0 |
| K013449 | MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING S | Disc-O-Tech Medical Technologies, Ltd. | 2001-12-19 | 63 | 0 |
| K010988 | FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-19 | 78 | 1 |
| K010901 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IMN) MODEL B | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-19 | 85 | 0 |
| K011390 | BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM | Disc-O-Tech Medical Technologies, Ltd. | 2001-06-06 | 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