Signal Medical Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Signal Medical Corp.” (first 1997, latest 2021), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 160 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 1 | 164 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Signal Medical Corp. took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Signal Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203779 | Symmetric Total Knee System | MBH | 2021-06-10 | 164 |
| K100370 | SYMMETRIC TOTAL KNEE AGUMENTS | JWH | 2011-03-07 | 388 |
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM | JWH | 2008-07-03 | 160 |
| K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) | HTY | 2008-03-24 | 87 |
| K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM | MBH | 2006-03-22 | 288 |
| K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT | KTT | 2005-02-11 | 74 |
| K022382 | RHS ACETABULAR COMPONENT | LPH | 2002-10-04 | 74 |
| K021063 | GREAT TOE IMPLANT | KWD | 2002-07-01 | 90 |
| K981302 | SMC 28MM CERAMIC FEMORAL HEADS | LZO | 1998-06-25 | 77 |
| K971681 | SMC FEMORAL HIP COMPONENT | JDI | 1997-12-04 | 212 |
1 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2017-02-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Signal West (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Signal Medical Corp.?
FDA lists 11 510(k) clearances under the applicant name “Signal Medical Corp.” (first 1997, latest 2021), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Signal Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Signal Medical Corp. is 160 days.
Which FDA product codes appear under Signal Medical Corp.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2); MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, 2).
Next steps
- See all 11 Signal Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Signal Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.