Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Whiteside Biomechanics, Inc. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
287 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033313 | QUATRO M FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 2004-07-28 | 287 | 0 |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | Whiteside Biomechanics, Inc. | 2002-05-03 | 255 | 0 |
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYS | Whiteside Biomechanics, Inc. | 2001-05-23 | 182 | 0 |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO | Whiteside Biomechanics, Inc. | 2000-02-14 | 90 | 0 |
| K991678 | WHITESIDE BIOMECHANICS SPINAL SYSTEM | Whiteside Biomechanics, Inc. | 1999-08-12 | 87 | 0 |
| K981238 | BIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1998-08-21 | 140 | 0 |
| K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1997-11-24 | 87 | 0 |
| K964616 | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT | Whiteside Biomechanics, Inc. | 1997-08-07 | 287 | 0 |
| K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1997-07-30 | 82 | 0 |
| K971718 | MICRO-SEAL ACETABULAR SYSTEM | Whiteside Biomechanics, Inc. | 1997-07-23 | 75 | 0 |
| K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1996-12-27 | 72 | 0 |
| K961625 | QUATROLOC FEMORAL COMPONENT & HEAD | Whiteside Biomechanics, Inc. | 1996-09-10 | 137 | 0 |
| K961157 | WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW | Whiteside Biomechanics, Inc. | 1996-05-17 | 56 | 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