Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MBB — Predicate Candidate Screening
19 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
275 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252443 | SpaceFix Shoulder Spacer | G21, S.R.L. | 2025-09-15 | 42 | 0 |
| K242216 | GENTAFIX® (1, 3, 3MV) | Teknimed Sas | 2024-12-18 | 142 | 0 |
| K240856 | Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds | Osartis GmbH | 2024-11-20 | 237 | 0 |
| K222760 | StageOne™ Select Hip Cement Spacer Molds | Biomet, Inc. | 2022-12-28 | 106 | 0 |
| K221968 | StageOne™ Shoulder Cement Spacer Molds | Biomet, Inc. | 2022-09-15 | 72 | 0 |
| K213287 | StageOne Knee Cement Spacer Molds | Biomet, Inc. | 2022-09-02 | 336 | 0 |
| K202338 | SpaceFlex Shoulder | G21, S.R.L. | 2021-02-17 | 184 | 0 |
| K201960 | SpaceFlex Knee - 80mm Size | G21, S.R.L. | 2020-08-13 | 30 | 0 |
| K192041 | G21 SpaceFlex Hip | G21, S.R.L. | 2019-10-29 | 90 | 0 |
| K190216 | SpaceFlex Knee | G21, S.R.L. | 2019-06-09 | 125 | 0 |
| K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee P | Biomet, Inc. | 2017-01-25 | 265 | 8 |
| K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replac | Biomet, Inc. | 2016-09-08 | 135 | 15 |
| K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-S | Biomet, Inc. | 2016-06-16 | 155 | 5 |
| K150850 | Refobacin Bone Cement R | Biomet, Inc. | 2015-07-16 | 107 | 0 |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORAR | Biomet Manufacturing Corp | 2014-01-22 | 275 | 5 |
| K081163 | SMARTSET GMV GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2008-05-14 | 20 | 0 |
| K063857 | SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT | Howmedica Osteonics Corp. | 2007-02-26 | 60 | 0 |
| K061144 | DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2006-06-08 | 44 | 0 |
| K053002 | DEPUY CMW 1 GENTAMICIN BONE CEMENT | DePuy Orthopaedics, Inc. | 2005-11-22 | 27 | 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