HK-Fy family
Standoff plus selected foot
The quoted configuration includes an articulated standoff and one selected compatible foot.
Single-Use Cardiac Stabilization System
CE Class IIIFDA Listed · 510(k)-ExemptSingle-Use
Heart Stabilizer System for OPCAB and selected MICS / MIDCAB configurations.
Compare four support-arm references and select the appropriate stabilization or positioning foot. HK-Fy and HK-Fy-R(II) are offered as complete stabilizer configurations; straight-rod options require confirmation of the selected foot and supply contents.
Final selection, mounting, permitted combinations, and clinical use should follow the current IFU, surgeon assessment, institutional protocol, and target-market requirements.
4 standoff referencesPublic international portfolio
4 SF working endsStabilization and positioning options
EO sterileSingle-use supply
3-year shelf lifeSubject to current labeling
Quick Answer
Confirm the complete configuration, not only the arm model.
HK-Fy and HK-Fy-R(II) quotations include a selected compatible foot. Confirm tubing and accessories by SKU. For HK-Yg and HK-Zg, check the exact supply contents; HK-GDQ is a separate reusable-frame pathway.
Straight-rod options
Check the quotation scope
HK-Yg and HK-Zg support models need explicit confirmation of the included foot and parts.
Foot selection
Current MDD naming
SF-III is larger with four suction openings; SF-IV is compact with three.
Documentation
Model-specific review
CE, FDA listing, IFU, labels, and permitted combinations should be confirmed before use.
System Relationship
Support structure plus compatible working end.
This describes the product architecture, not a universal sales bundle or permission to interchange every foot and support.
Heart Stabilizer configuration
The standoff provides support; the compatible SF working end performs local stabilization or heart positioning. HK-Fy / HK-Fy-R(II) include a selected foot, while straight-rod configurations need an explicit parts list.
Support arm + documented SF foot + applicable tubing / mount = confirmed configuration
Standoff Models
Four public references for different access and mounting discussions.
Structure and dimensions must be checked against the applicable model label and IFU before quotation or registration.
| Public Model | Structure | Surgical Approach | Arm Length | Mounting Discussion |
|---|---|---|---|---|
| HK-Fy | R(I) articulated | OPCAB · median sternotomy | 155 mm ± 15 mm | Selected HK-FXG-Q / HK-SR configuration where documented. |
| HK-Fy-R(II) | R(II) articulated | OPCAB · median sternotomy | 155 mm ± 15 mm | Selected HK-FXG-Q / HK-SR configuration where documented. |
| HK-Yg | Straight rod · extended reach | Selected MICS / MIDCAB evaluation | 235 mm ± 15 mm | Compatible table-side holding arrangement; confirm during technical evaluation. |
| HK-Zg | Straight rod · standard reach | Selected MICS / MIDCAB evaluation | 190 mm ± 15 mm | Compatible table-side holding arrangement; confirm during technical evaluation. |
Supply and naming: HK-Fy / HK-Fy-R(II) quotations include one selected compatible foot with the standoff. HK-Yg is quoted as a support arm without a foot unless the quotation expressly adds one. Confirm HK-Zg contents before quoting. Public HK-Yg / HK-Zg may appear as HK-Fy-Yg / HK-Fy-Zg in MDR materials; use the applicable approved labeling.
Compatible Working Ends
Choose the documented foot for the support and clinical task.
For current MDD-labeled models, SF-III is the larger four-opening vacuum foot; SF-IV is the compact three-opening foot. Planned MDR numbering reverses III and IV, so the applicable label controls.
Negative Pressure · Current MDD
SF-III / SF-IV
SF-III: larger four-opening foot. SF-IV: smaller three-opening foot.
Planned MDR naming swaps III and IV. Verify the current label, foot image, and permitted pairing before supply.
Mechanical
SF-V
Mechanical pressure-stabilization configuration without a vacuum pathway.
Selection should follow the documented product configuration.
Positioning
SF-VII
Apical or heart-positioning configuration presented for selected exposure discussions.
This page does not prescribe a procedural technique.
Selection Guide
Start with the access approach, then confirm the working end and documents.
Pathway 01
Classic sternotomy OPCAB
HK-Fy or HK-Fy-R(II) quotations include a selected compatible foot. SF-III (current MDD: larger, four openings) is the usual starting choice; confirm the surgeon's preference and accessory list.
- Confirm standoff reference
- Confirm labeled SF foot and mounting
- Request model-specific documents
Pathway 02
Selected MICS / MIDCAB
Evaluate HK-Yg or HK-Zg according to access and reach. HK-Yg is quoted as a support arm without a foot; add a surgeon-selected, documented foot and any required accessories explicitly.
- Confirm public and MDR model name
- List included parts in the offer
- Confirm target-market scope
Alternative
Reusable support-frame pathway
Review HK-GDQ-Q or HK-GDQ-Z separately when the center is evaluating a reusable frame with compatible disposable SF working ends.
- Different regulatory path
- Different reprocessing requirements
- No published reuse-cycle number on this site
Clinical-use boundary: These pathways organize product evaluation. They do not replace the current IFU, training, surgeon assessment, or hospital protocol.
General Specifications
Public information for initial distributor review.
| Parameter | Public Website Information |
|---|---|
| Use status | Class III single-use system |
| Sterilization | Ethylene oxide (EO) |
| Sterile barrier | Double sterile barrier for the Heart Stabilizer; configuration-specific packaging should be confirmed |
| Shelf life | 3 years from sterilization date, subject to current labeling |
| Storage | 0–35 °C · keep dry · protect from sunlight |
| Vacuum configurations | Specified vacuum range should be confirmed in the applicable IFU |
| Manufacturer | Beijing HangTian KaDi Technology R&D Institute |
| Documentation | IFU, labels, CE documentation, FDA listing information, model matrix, packaging details |
Regulatory Status
CE Class III and FDA listed / 510(k)-exempt are different pathways.
The page avoids the phrase “FDA approved” and does not extend one status to every cardiac product family.
Public status
The single-use Heart Stabilizer is presented as CE Class III under the applicable MDD certificate and MDR Article 120 transitional documentation. It is also presented as FDA listed under Product Code MWS and 510(k)-exempt. Exact model and market scope must be verified before submission or sale.
CE Class IIIMDD certificate G1 090358 0005 Rev.03 and transitional confirmation CL 090358 0009 Rev.00 are referenced in the source page.
FDA listingProduct Code MWS · 510(k)-exempt. This is not an FDA approval claim.
Qualified-partner packageCurrent certificates, IFU, labels, model list, manufacturer information, and market-specific documents.
Resources
Product-specific education and distributor support.
FAQ
Heart Stabilizer questions.
What is the AeroMed Heart Stabilizer System?
It is a single-use cardiac stabilization system for documented OPCAB and selected MICS / MIDCAB workflows. HK-Fy and HK-Fy-R(II) are supplied as complete quoted configurations with a selected foot; confirm tubing and accessories by SKU. Straight-rod model contents require separate confirmation.
Which standoff models are presented internationally?
The public portfolio presents HK-Fy and HK-Fy-R(II) for classic OPCAB configurations, and HK-Yg and HK-Zg for selected minimally invasive cardiac configurations. MDR documentation may use HK-Fy-Yg and HK-Fy-Zg naming for the latter two models.
How is the Heart Stabilizer different from HK-GDQ?
The Heart Stabilizer page covers single-use standoff configurations. HK-GDQ is a separate reusable support-frame family. The two pathways have different reprocessing and mounting requirements.
Which stabilizer foot models can be evaluated?
Under current MDD naming, SF-III is the larger four-opening vacuum foot and SF-IV is the compact three-opening foot. SF-V is mechanical and SF-VII is for heart positioning. Planned MDR numbering swaps III and IV, so confirm the applicable label and IFU.
What is the FDA status of the Heart Stabilizer?
The Heart Stabilizer is presented as FDA listed under Product Code MWS and 510(k)-exempt. This is not an FDA approval claim. Current FDA records and exact manufacturer and model information should be checked before commercial use.
What is the CE status of the Heart Stabilizer?
The single-use Heart Stabilizer system is presented as CE Class III under the applicable MDD certificate and MDR Article 120 transitional documentation. Exact certificate, model, and market scope are available to qualified partners.
What should a distributor provide when requesting samples?
Provide the target country, surgical approach, preferred standoff, required SF working end, evaluation quantity, hospital type, and required regulatory documents. AeroMed can then prepare a model-specific evaluation package.
Request the Heart Stabilizer model matrix.
Provide your target country, surgical approach, preferred standoff, SF working-end interest, evaluation quantity, and required regulatory documents.