Current MDD
SF-III · four openings
Larger negative-pressure foot; usual starting choice for HK-Fy family evaluations.
Cardiac Stabilizer Working Ends
CE · Heart Stabilizer Component ScopeSterile Single-Use4 Public Configurations
Stabilizer Foot Family: four working-end configurations.
Under current MDD labeling, SF-III is the larger four-opening vacuum foot and SF-IV is the smaller three-opening foot. Compare these with SF-V mechanical stabilization and SF-VII heart positioning, then confirm the labeled model in the complete configuration.
Planned MDR documents reverse the III / IV numbering. Current MDD labels and IFUs govern present supply; dimensions, permitted pairings, and vacuum requirements require model-specific confirmation.
SF-III · MDDLarger vacuum foot · four openings
SF-IV · MDDCompact vacuum foot · three openings
SF-VMechanical · no vacuum
SF-VIIHeart positioning
Quick Answer
The foot is the working end; the label identifies the version.
The physical size and number of suction openings matter more than the numeral alone during the MDD-to-MDR naming transition.
Current MDD
SF-IV · three openings
Smaller, compact negative-pressure foot.
Supply scope
Check the quote
HK-Fy / HK-Fy-R(II) include a selected foot; HK-Yg is quoted without one unless specified.
Regulatory
Use the current label
Planned MDR numbering swaps III and IV. Verify exact product and market scope.
System Relationship
One working-end family, multiple support pathways.
SF working-end relationship
The support structure provides load support; the documented SF component performs local stabilization or heart positioning. An included foot in an HK-Fy set must not be charged again as an extra component.
Confirmed support + labeled SF foot + applicable tubing / mount = quoted configuration
Four Public Foot Configurations
Identify the physical foot and the applicable naming system.
The four cards use equal image areas so product scale is visually consistent. Photographs are not a substitute for dimensions or label confirmation.
MDD · Larger Vacuum Foot
SF-III · four openings
Larger local tissue-stabilization foot; the usual HK-Fy family selection, subject to surgeon preference.
Current MDD reference: HKSF-Fy (III). Verify the approved label.
MDD · Compact Vacuum Foot
SF-IV · three openings
Smaller local tissue-stabilization foot for a compact contact geometry.
Current MDD reference: HKSF-Fy (IV). Planned MDR III / IV numbering is reversed.
Mechanical · No Vacuum
SF-V
Mechanical pressure-stabilization configuration without a vacuum pathway.
Regulatory reference: HKSF-Zhy
Heart Positioning
SF-VII
Apical or heart-positioning configuration for selected exposure discussions.
Regulatory reference: HKSF-Fy
Model Comparison
Current MDD identity by physical configuration.
For exact blade dimensions, request the current approved model drawing and IFU for your target market.
| Current MDD Model | Regulatory Reference | Type | Main Function | Physical Identification |
|---|---|---|---|---|
| SF-III | HKSF-Fy (III) | Vacuum foot | Local target stabilization | Larger foot · four suction openings |
| SF-IV | HKSF-Fy (IV) | Vacuum foot | Local target stabilization | Smaller, compact foot · three suction openings |
| SF-V | HKSF-Zhy | Mechanical foot | Mechanical pressure stabilization | No vacuum pathway |
| SF-VII | HKSF-Fy | Positioning foot | Heart positioning | Apical positioning function · verify labeled configuration |
Numbering transition: under the current MDD documents, III = larger four-opening and IV = smaller three-opening. The planned MDR documentation reverses the III / IV identifiers. Do not substitute the future numbering on present labels, offers, or registration files.
Compatible Support Structures
Use a documented pairing—not a blanket compatibility claim.
| Support Configuration | Context | Public Pairing Logic |
|---|---|---|
| HK-Fy / HK-Zhy | Classic OPCAB configurations | Selected tissue-stabilization or positioning foot according to the product configuration and IFU. |
| HK-Fy-Yg / HK-Fy-Zg | Selected MICS / MIDCAB straight-rod workflow | Use where the working-end pairing is documented for the straight-rod configuration. |
| HK-GDQ-Q / HK-GDQ-Z | Reusable support-frame workflow | Shared SF family where supported by the current AeroMed configuration and distributor documents. |
Compatibility boundary: Do not state that every SF foot fits every support structure unless the latest model matrix and IFU confirm the exact pairing.
General Product Characteristics
Single-use working-end information.
| Parameter | Public Website Information |
|---|---|
| Use status | Sterile single-use component |
| Sterilization | Ethylene oxide (EO) |
| Reuse | Do not reuse · do not re-sterilize |
| Shelf life | 3 years from sterilization date, subject to current labeling |
| Storage | 0–35 °C · keep dry · protect from sunlight |
| Materials | Silicone rubber, 304 stainless steel, polycarbonate, PVC, and medical-grade plastics where applicable |
| Tissue contact | Foot blade / contact surface |
| Vacuum accessories | Suction tube, valve, extension tube, Luer connector, and source connector where applicable |
Regulatory Status
Presented within the applicable Heart Stabilizer component scope.
Public status
The SF working ends are presented as CE components within the applicable Heart Stabilizer documentation. FDA relevance follows the exact Heart Stabilizer listing and model relationship; this page does not claim a separate FDA clearance or approval for each foot.
CE component scopeConfirm public and regulatory model names and permitted combinations.
FDA wordingUse the applicable Heart Stabilizer listing relationship; do not use “FDA approved.”
Distributor packageModel matrix, IFU, labels, dimensions, sterilization, shelf life, and packaging details.
FAQ
Stabilizer Foot questions.
What is the Stabilizer Foot Family?
The SF family contains the tissue-contact or positioning working ends used with compatible AeroMed cardiac stabilizer support structures. HK-Fy / HK-Fy-R(II) quotations include a selected compatible foot; HK-Yg is quoted without one unless specified.
Which public SF models are presented?
The public international portfolio presents SF-III, SF-IV, SF-V, and SF-VII. Regulatory documents may use HKSF-Fy and HKSF-Zhy naming for the same family.
What is the difference between SF-III and SF-IV?
Both are negative-pressure stabilization configurations. Under current MDD naming, SF-III is the larger four-opening vacuum foot and SF-IV is the smaller three-opening foot. Planned MDR documents reverse the III / IV labels; use the applicable approved IFU and label.
What is SF-V?
SF-V is the mechanical stabilization configuration and does not use the vacuum pathway described for SF-III and SF-IV.
What is SF-VII?
SF-VII is presented as an apical or heart-positioning configuration. It should not be described as the same functional category as the local tissue-stabilization feet.
Are the stabilizer feet reusable?
The SF working ends are supplied as sterile single-use components. Reuse and re-sterilization are not permitted unless the approved labeling for a specific market states otherwise.
Which support structures can use the SF family?
Selected pairings are documented for single-use standoffs, straight-rod configurations, and HK-GDQ reusable frames. Exact permitted combinations must be confirmed against the current IFU and model matrix.
Request the SF foot comparison matrix.
Tell us the support structure, target workflow, preferred foot function, target country, and evaluation quantity.