Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NQP — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
302 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203678 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021-01-15 | 29 | 0 |
| K191066 | CD Horizon™ Astute™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-10-03 | 164 | 0 |
| K182928 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019-01-11 | 81 | 0 |
| K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2014-01-16 | 91 | 0 |
| K101704 | ZIMMER DTO PIN PRESS INSTRUMENT | Zimmer Spine, Inc. | 2010-08-18 | 62 | 0 |
| K101083 | DSS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2010-07-02 | 74 | 0 |
| K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2009-10-01 | 70 | 0 |
| K091944 | MODIFICATION TO: DSS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2009-08-03 | 34 | 0 |
| K073439 | TRANSITION STABILIZATION SYSTEM | Globus Medical, Inc. | 2009-02-20 | 441 | 0 |
| K080241 | DDS STABILIZATION SYSTEM | Paradigm Spine, LLC | 2008-11-28 | 302 | 0 |
| K080963 | DSS STABILIZATION SYSTEM | Paradigm Spine | 2008-05-02 | 28 | 0 |
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | Scient'X | 2008-04-17 | 349 | 0 |
| K072321 | BIOFLEX | Biospine Co., Ltd. | 2008-03-25 | 218 | 0 |
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | Zimmer Spine, Inc. | 2008-02-08 | 71 | 2 |
| K072969 | DSS | Paradigm Spine, LLC | 2008-01-24 | 94 | 0 |
| K072685 | NGARDE SYSTEM | N Spine, Inc. | 2007-10-19 | 28 | 9 |
| K071879 | ZIMMER DTO IMPLANT | Zimmer Spine, Inc. | 2007-10-05 | 88 | 1 |
| K061774 | NFIX II PEDICLE SCREW SYSTEM | N Spine, Inc. | 2006-12-13 | 173 | 7 |
| K061304 | CD HORIZON SPINAL SYSTEM | Medtronic Sofamor Danek | 2006-07-18 | 69 | 0 |
| K060638 | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS | Zimmer Spine, Inc. | 2006-04-06 | 27 | 1 |
| K043565 | MODIFICATION TO DYNESYS SPINAL SYSTEM | Zimmer Spine, Inc. | 2005-03-11 | 74 | 1 |
| K031511 | DYNESYS SPINAL SYSTEM | Centerpulse Spine-Tech, Inc. | 2004-03-05 | 296 | 4 |
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