Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBW · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
319 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251472 | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion C | Inion OY | 2025-07-11 | 59 | 0 |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-14 | 109 | 0 |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | 2017-05-19 | 29 | 0 |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III | Stryker | 2015-06-24 | 29 | 0 |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | 2015-03-27 | 304 | 1 |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | 2010-12-03 | 155 | 0 |
| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FR | Biomedical Ent., Inc. | 2001-03-13 | 319 | 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