Hayes Medical, Inc.: FDA clearances and approvals
Hayes Medical, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2007), across 6 product codes in 1 review panel. Median 510(k) review time: 86 days.
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 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
Review panels
- Orthopedic (12)
Most recent Hayes Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070061 | 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT | LWJ | 2007-01-31 | 26 |
| K062383 | UNISYN HA PLASMA MODULAR HIP | LWJ | 2006-12-21 | 128 |
| K060635 | CONSENSUS ACETABULAR SHELL SYSTEM | LPH | 2006-04-28 | 49 |
| K030151 | CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM | LZO | 2003-04-10 | 85 |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | KWL | 2003-04-01 | 70 |
| K021466 | CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE | LPH | 2002-07-24 | 78 |
| K020153 | CONSENSUS ACETABLAR SHELL, TI COATED | LPH | 2002-04-15 | 89 |
| K003649 | TRITON HIP SYSTEM | LWJ | 2001-02-23 | 88 |
| K001456 | CONSENSUS KNEE SYSTEM | JWH | 2000-08-07 | 90 |
| K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI | JWH | 1998-11-25 | 89 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hayes Medical, Inc..
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 Hayes Medical, Inc. have?
Hayes Medical, Inc. has 12 FDA 510(k) clearances (first 1995, latest 2007), across 6 product codes in 1 review panel.
How long does FDA take to clear Hayes Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hayes Medical, Inc.'s cleared 510(k)s is 86 days.
What devices does Hayes Medical, Inc. make?
Its most frequent FDA product codes are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 3); LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, 3); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2).
Has Hayes Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hayes Medical, Inc. Related entities may recall under other names.
Next steps
- See all 12 Hayes Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LPH, Hayes Medical, 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.