Whiteside Biomechanics, Inc.: FDA clearances and approvals
Whiteside Biomechanics, Inc. has 13 FDA 510(k) clearances (first 1996, latest 2004), across 9 product codes in 1 review panel. Median 510(k) review time: 90 days. openFDA lists 1 product recall by a recalling firm named Whiteside Biomechanics, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 1 | 1 |
| NDD | Cerclage, Fixation, Metallic | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Whiteside Biomechanics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033313 | QUATRO M FEMORAL COMPONENT | LWJ | 2004-07-28 | 287 |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | HRY | 2002-05-03 | 255 |
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | NDD | 2001-05-23 | 182 |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | JDQ | 2000-02-14 | 90 |
| K991678 | WHITESIDE BIOMECHANICS SPINAL SYSTEM | KWQ | 1999-08-12 | 87 |
| K981238 | BIPOLAR FEMORAL HEAD | KWY | 1998-08-21 | 140 |
| K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD | LZO | 1997-11-24 | 87 |
| K964616 | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT | LPH | 1997-08-07 | 287 |
| K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD | LZO | 1997-07-30 | 82 |
| K971718 | MICRO-SEAL ACETABULAR SYSTEM | LPH | 1997-07-23 | 75 |
3 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-09-15.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Whiteside Biomechanics, Inc. have?
Whiteside Biomechanics, Inc. has 13 FDA 510(k) clearances (first 1996, latest 2004), across 9 product codes in 1 review panel.
How long does FDA take to clear Whiteside Biomechanics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Whiteside Biomechanics, Inc.'s cleared 510(k)s is 90 days.
What devices does Whiteside Biomechanics, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 3); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 3); HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, 1).
Has Whiteside Biomechanics, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Whiteside Biomechanics, Inc; the most recent began 2006-09-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 13 Whiteside Biomechanics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Whiteside Biomechanics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.