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Sign in to claim this brandSignal Medical Corp.
US
Last updated May 23, 2026
What Signal Medical Corp. makes
Signal Medical Corp. manufactures orthopedic implants and surgical instruments for hip and knee arthroplasty, including tibial inserts, coated femoral and tibial extensions, press-fit hip prostheses, bipolar femoral heads, coated knee prostheses, acetabular liners, and knee arthroplasty wedges. Their portfolio also includes revision stems, unicondylar knee components, and specialized tools like retractors and osteotomes.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, reflecting their compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Signal Medical Corp. manufacture?
Signal Medical Corp. specializes in orthopedic implants and surgical instruments primarily for hip and knee arthroplasty procedures. Their product portfolio includes tibial inserts, coated femoral and tibial extensions, press-fit hip femur prostheses, bipolar femoral head components for hemiarthroplasty, coated knee femur prostheses, metallic acetabular liners, knee arthroplasty wedges, and coated unicondylar knee tibia prostheses. They also produce revision stems and specialized surgical tools like retractors and osteotomes.
Where is Signal Medical Corp. based, and how does that affect its regulatory standing?
Signal Medical Corp. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those administered by the FDA. Since the company operates within the U.S., its products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries, ensuring compliance with domestic medical device regulations. The FDA classifies their devices as either Class I or Class II, depending on their risk level and intended use.
Which regulatory registries list Signal Medical Corp.’s devices, and why?
Signal Medical Corp.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) registry documents premarket submissions demonstrating that a device is substantially equivalent to legally marketed predicates, while the UDI registry ensures traceability and compliance tracking for all medical devices sold in the U.S. These listings reflect the company’s adherence to FDA requirements for device authorization.
How are Signal Medical Corp.’s devices classified under FDA regulations?
Signal Medical Corp.’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices generally pose the lowest risk and may be exempt from some regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as orthopedic implants for joint replacement.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (297)
Page 3 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultra Tibial Insert | 7x12 | FDA UDI | Class II | Active |
| Coated Revision Stem | 14x100 | FDA UDI | Class II | Active |
| Ceramic Femoral Head | 32mm -3.5mm | FDA UDI | Class II | Active |
| Standard Tibial Insert | 5x16 | FDA UDI | Class II | Active |
| Microseal Anatomic10 Degree Liner | 28x54x10 | FDA UDI | Class II | Active |
| Micro Seal Shell | 56mm | FDA UDI | Class II | Active |
| Micro Seal Shell | 44mm | FDA UDI | Class II | Active |
| Microseal Anatomic 10 Degree Liner | 26x52x10 | FDA UDI | Class II | Active |
| AdvantageRib | 323.1203 | FDA UDI | Class II | Active |
| Uni Femoral Knee | 3 | FDA UDI | Class II | Active |
| Uni Tibial Tray | 3 | FDA UDI | Class II | Active |
| Microseal Anatomic 10 Degree Liner | 28x56x10 | FDA UDI | Class II | Active |
| Ultra Tibial Insert | 3x10 | FDA UDI | Class II | Active |
| Metaphyseal Stem | 24 x 65 | FDA UDI | Class II | Active |
| AdvantageRib | 323.1206 | FDA UDI | Class II | Active |
| Microseal Augmented 20 Degree Liner | 32x52x20 | FDA UDI | Class II | Active |
| Quatro-M Femoral Stem | 4L | FDA UDI | Class II | Active |
| Coated Revision Stem | 10x200 | FDA UDI | Class II | Active |
| Ultra Tibial Insert | 6x25 | FDA UDI | Class II | Active |
| Ultra Tibail Insert | 3x25 | FDA UDI | Class II | Active |
| Symmetric TK Femoral Component | 5RT | FDA UDI | Class II | Active |
| AdvantageRib | 323.1010 | FDA UDI | Class II | Active |
| Standard Tibial Insert | 6x10 | FDA UDI | Class II | Active |
| Standard Tibial Insert | 7x12 | FDA UDI | Class II | Active |
| Standard Tibial Insert | 4x14 | FDA UDI | Class II | Active |
| AdvantageRib | 323.1005 | FDA UDI | Class II | Active |
| Ultra Tibial Insert | 3x20 | FDA UDI | Class II | Active |
| AdvantageRib | 323.1012 | FDA UDI | Class II | Active |
| AdvantageRib | 323.1202 | FDA UDI | Class II | Active |
| Quatro-M Femoral Stem | 4S | FDA UDI | Class II | Active |
| Quatro-M Femoral Stem | 5XS | FDA UDI | Class II | Active |
| AdvantageRib | 323.1013 | FDA UDI | Class II | Active |
| Micro Seal Shell | 64mm | FDA UDI | Class II | Active |
| Coated Revision Stem | 18x100 | FDA UDI | Class II | Active |
| AdvantageRib | 323.0071 | FDA UDI | Class II | Active |
| Micro Seal Shell | 50mm | FDA UDI | Class II | Active |
| Boot Assembly | BIO-1-1022 | FDA UDI | Class I | Active |
| Ultra Tibial Insert | 5x20 | FDA UDI | Class II | Active |
| Femoral Wedge | 7-8 Posterior Thick | FDA UDI | Class II | Active |
| AdvantageRib | 323.0056 | FDA UDI | Class II | Active |
| Cancellous Bone Screw | 15mm | FDA UDI | Class II | Active |
| Ultra Tibial Insert | 6x30 | FDA UDI | Class II | Active |
| Patellar Button | 28/40 | FDA UDI | Class II | Active |
| Quatro-M Femoral Stem | 3XS | FDA UDI | Class II | Active |
| Standard Tibial Insert | 6x14 | FDA UDI | Class II | Active |
| Standard Tibial Insert | 6x16 | FDA UDI | Class II | Active |
| Femoral Belt | N/A | FDA UDI | Class I | Active |
| Microseal Anatomic 10 Degree Liner | 26x48x10 | FDA UDI | Class II | Active |
| AdvantageRib | 323.0010 | FDA UDI | Class II | Active |
| Symmetric Total Knee Tibial Tray | Size: 3 | FDA UDI | Class II | Active |
Related Companies
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Signal Medical Corp. has three FDA recall records initiated between September 23, 2014, and February 20, 2017, all of which are marked as terminated. The reasons cited include a potential detachment of a poly tip during use, which could introduce foreign material or delay surgery, along with instructions regarding proper cleaning and sterilization procedures; an incorrect dimension on four liners; and compromised packaging of a device.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 20, 2017 | Z-1834-2017 | — | terminated | Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet. |
| Sep 30, 2014 | Z-0111-2015 | — | terminated | Packaging of a device was compromised |
| Sep 23, 2014 | Z-0109-2015 | — | terminated | Incorrect dimension on four liners was detected |