Challenging bone
- Irregular in shape and contour
- Poor bone quality, often compared to balsa wood
- A very thin outer cortical shell limits fixation strength
VariTrax™ Sternal CircumFixator™
Sound biomechanics
improve biological
healing.
A screwless, all-PEEK system that splints the full length of the sternum and wraps it with tensioned bands, giving rigid fixation that shares load with the bone.
FDA 510(k) cleared · Radiolucent · MRI safe · Single-use sterile kit
The clinical problem
The sternum is uniquely difficult to fix
Most sternotomies are still closed with steel wire, a technique that approximates the bone but does not hold it. In fragile, high-risk patients, the resulting instability drives infection, pain and non-union.
700Ksternotomy procedures performed in the US each year
85%of sternal closures performed with steel wire
~27%of sternal wires found fractured after coronary surgery
Sources: Cleveland Clinic, Sternotomy: Procedure Details & Recovery (2025); internal survey research; Stoklosa K, et al. Ann Thorac Surg. 2026;122(1):46–56.
High-risk patients
- One-third of patients are high risk for complications
- Comorbidities such as diabetes, obesity and osteoporosis slow recovery
Instability drives complications
- Infection
- Pain
- Non-union and delayed union
Sternal complications are frequent, costly and dangerous
Up to 56,000 sternal complications occur each year after cardiac surgery. The ERAS® Cardiac Society recommends improved sternal fixation for all patients, not only those at high risk.
0.5–8.4%
Sternal dehiscence
Reported incidence after median sternotomy
0.6–5%
Deep sternal wound infection
Mortality up to 47% if unaddressed
0.5–3%
Sternal non-union
Delayed healing and chronic instability
7–66%
Post-sternotomy pain syndrome
Lower patient satisfaction and mobility
The cost of open heart readmissions
Cost per case
$15–25Ktypical cost of one 30-day open heart readmissionUS, approximate4
$36.8Kmean cost per sternal wound infection (US)about $336M a year nationally1
~3×hospital cost with vs. without a deep infectionmedian €36,261 vs. €13,3562
Medicare penalty exposure
CABG is in the Hospital Readmissions Reduction Program: excess readmissions can cut up to 3% of base Medicare inpatient payments, hospital-wide.3
Rule of thumb: about $2,200 per patient
About 11% readmitted × about $20K each. Sternal cases are about 10% of readmissions but cost far more apiece.
- 1. Brandt D, Blüher M, Lankiewicz J, Mallow PJ, Saunders R. Sternal-wound infections following coronary artery bypass graft: could implementing value-based purchasing be beneficial? J Health Econ Outcomes Res. 2020;7(2):130–138 (2017 US$).
- 3. CMS Hospital Readmissions Reduction Program.
- 2. Graf K, Ott E, Vonberg R-P, Kuehn C, Haverich A, Chaberny IF. Economic aspects of deep sternal wound infections. Eur J Cardiothorac Surg. 2010;37(4):893–896 (German case-control study, costs in euros).
- 4. The $15–25K readmission cost is an approximate estimate from published literature.
Closing the gap
Wires vs. plates vs. VariTrax™
Wire is fast but unstable. Rigid plates are stable but rely on screws in fragile bone. VariTrax™ delivers rigid fixation without drilling a single hole.
| Wire cerclage | Rigid plates & screws | VariTrax™ screwless rigid fixation | |
|---|---|---|---|
| Fixation type | Approximation only | Rigid fixation with screws | Rigid, screwless, full-length splinting |
| Biomechanical stability | Low; allows micromotion | High; rigid but localized | High; rigid with physiologic load sharing |
| Resistance to shear | Poor | Good | Excellent; circumferential and longitudinal control |
| Risk of cut-through | High, especially in fragile bone | Moderate; screws can loosen | Very low; broad bands, no screws |
| Osteoporotic bone | Poor | Variable | Strong; bone-sparing, no drilling |
| Bone bleeding | Oozing of sternal halves | Oozing of halves and screw holes | Minimal; no drill or screw holes |
| Imaging | Metal artifact | Some artifact | Radiolucent; clear X-ray, CT and MRI |
| OR workflow | Fast but inconsistent | Slower; measure, drill, insert screws | Fast and reproducible; 5–6 minute closure |
| Ideal patient | Low-risk only | High-risk sternums | All sternums, especially high-risk, high-BMI or poor bone quality |
Ratings reflect published literature, the VariTrax™ 275-patient series and CircumFix biomechanical analysis. Not a head-to-head clinical trial.
The CircumFix™ solution
VariTrax™ Sternal CircumFixator™
An anatomic PEEK buttress plate runs the length of the sternum. Circumferential bands encircle the bone and lock into the plate, compressing the halves together while the plate controls longitudinal motion.
Anatomic
Conforming, low-profile buttress plate fits patient-specific anatomy.
3-dimensional stability
Circumferential compression plus longitudinal buttressing.1
Load sharing
Unibody construction shares load evenly between bone and device.1
Open architecture
Limited bone contact lets fluid flow under, through and around the implant.
Radiolucent
Does not interfere with post-operative X-ray, CT or MRI.
Biocompatible polymer
All implants are made with VESTAKEEP® PEEK, safe as a permanent implant.
Quick and reproducible
Bands are applied the same way every time, with no measuring or drilling.
Simple removal
Cut the bands for fast re-entry when emergent access is needed.
1 Internal data on file.
Surgical technique
Five steps to a VariTrax™ sternal closure
The procedure is the same in every patient, so closure is consistent from case to case and surgeon to surgeon.
- STEP 1
Measure the sternum
- STEP 2
Place locking bands
- STEP 3
Attach band heads to plate
- STEP 4
Insert and tension bands
- STEP 5
Final reduction with band excess removed
VariTrax Sternal CircumFixator SystemWatch on YouTube
VariTrax Sternal CircumFixatorWatch on YouTube
CircumFix on YouTube →@CircumFixSolutions
Refer to IFU for complete surgical technique. CAUTION: Federal law restricts these devices to sale by or on the order of a physician.
Indications
Built for the patients who need it most
The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Patients who benefit most
- High-risk patients with multiple comorbidities (diabetes, osteoporosis, smoking, high BMI)
- Redo or revision sternotomy
- Obesity (BMI > 30)
- Internal mammary artery harvest
- Poor bone quality, such as elderly or osteoporotic patients
- Transplant patients
- Metal sensitivity (nickel allergy)
- Patients requiring post-op MRI (MRI safe)
- Abnormal anatomy, such as Marfan syndrome
Clinical value
- Circumferential bands deliver compressive strength
- Buttress plate delivers stability
- Load sharing for reliable, complete healing
- Easy removal and re-access
Economic value
- Time-efficient 5–6 minute closure
- No restocking trays or reprocessing
- Captured procedural pricing
- Lower pain scores support earlier discharge
Clinical evidence
Demonstrated safety and efficacy: 275-patient series
275
consecutive sternotomy closures, no exclusions for anatomy or bone quality
0
deep sternal wound infections
0
dehiscence or device failures
2–3/10
median pain score on post-op day 1
Farivar RS. Continued experience (first 275 patients) with VariTrax™ Sternal CircumFixator. Saint Alphonsus Regional Medical Center, January 2026. Single-center series.
Robert Farivar, MD, PhDMedical Director, Cardiothoracic Surgery · Saint Alphonsus Regional Medical Center, Boise, ID
Patient cohort
- 275 consecutive sternotomy closures: CABG, valve, aortic, combined
- Median age 67, mean BMI 31.4, 22% diabetic
- Redo sternotomy ~6%
- No exclusions for anatomy or bone quality
Clinical results
- Median post-op stay 5.0 days
- Fixation maintained through CPR, MCS and non-sternal reoperations
- POD1 pain 2–3/10, with reduced narcotic use vs. wire
Clinical conclusionVariTrax™ demonstrates consistent safety, durability, low pain and stable fixation across diverse cardiac procedures and high-risk patients. Surgeons report predictable application, excellent stability and easy removal.
The author receives no funding for the reporting of this series.
| n = 275 | Mean | Median | Range |
|---|---|---|---|
| Age (years) | 66 | 67 | 19–82 |
| BMI | 31.4 | 30.7 | 18.8–48.7 |
| Weight (kg) | 96 | 94 | 53–158 |
| Post-op LOS (days) | 6.1 | 5.0 | 1–30 |
| Male | 70% (193) | ||
| Reoperation | 6% (16) | ||
| Diabetic | 22% (61) | ||
| Current tobacco use | 11% (30) | ||
Early Experience with VariTrax™ Sternal CircumFixator: A Promising New Rigid Sternal Closure System
Clinical paper, PDF
Download the clinical paper →
Biomechanics
Finite element study: closer-to-bone stiffness supports healing
A finite element analysis compared three sternal closure constructs under identical physiologic loading: stainless-steel wire cerclage, titanium plate fixation and the VariTrax™ buttress-and-band system.
How the study was run
- Models
- Simplified, symmetric sternum geometries, to avoid stress risers and isolate each construct's behavior
- Materials
- Published properties: titanium (E = 120 GPa), stainless-steel wire (E = 193 GPa) and PEEK for VariTrax™ (E = 3.95 GPa)
- Loads
- Applied the same way to all three models: lateral distraction 150 N, anterior–posterior shear 100 N, rostral–caudal shear 100 N
- Contact
- Realistic implant–bone interactions: sliding interfaces for wires and bands, fixed screw–bone interfaces for plates
Results
- Steel wire
- Largest displacements in all directions, with high stress concentrations at the wire–bone interface
- Titanium plates
- Lowest displacement and highest rigidity, but poor load sharing: stress concentrated in the implant and at the bone–screw interface
- VariTrax™
- Best balance of stability and load transfer, with rigidity closer to bone, higher load sharing and more even stress, especially in rostral–caudal loading
Mechanical trade-offs
Wire cerclage
Basic fixation with high displacement and localized bone stress.
Titanium plates
Maximum immediate rigidity, but reduced bone loading and screw-related stress risers.
VariTrax™ system
Balanced stability plus physiologic load sharing. Its modulus and mechanics align with Wolff's law.
Bottom line: constructs with rigidity closer to bone, such as VariTrax™, may better support long-term healing while maintaining sufficient mechanical stability.
How it works
CircumFixation™ is a total solution
Immobilizes the bisected sternum
Tensioned bands compress the plate and segments, anatomically immobilizing the sternum.
Cradles without strangulating
Bands and plate support the bone without risking unintended damage.
Bone-like modulus
The implant design and the modulus of PEEK combine to share load evenly with the bone.
Maintains reduction
The construct neutralizes and dissipates forces on the sternum, holding anatomic reduction for reliable healing.
Product & ordering
Single-use, sterile-packed procedure kit
Everything for one closure arrives in one sterile kit. There are no trays to reprocess or restock, and no inventory shrinkage.
Instructions for use
Licensed healthcare professionals should download, print and review the IFU, and keep it available for reference during any procedure. IFUs may be revised from time to time, so check this page for the current version before each procedure. For a printed copy at no charge, contact us.
| Part number | Description |
|---|---|
| CFSK-0130 | VariTrax™ Sternal CircumFixator™ Set, 130 mm |
| CFSK-0142 | VariTrax™ Sternal CircumFixator™ Set, 142 mm |
| CFSK-0154 | VariTrax™ Sternal CircumFixator™ Set, 154 mm |
| CFSK-0166 | VariTrax™ Sternal CircumFixator™ Set, 166 mm |
| CFSK-0178 | VariTrax™ Sternal CircumFixator™ Set, 178 mm |
| CFSK-0186 | VariTrax™ Sternal CircumFixator™ Set, 186 mm |
| CFTK-TEMP | VariTrax™ Template Kit |
| CFIK-INST | VariTrax™ Instrument Kit |
| CFSB-001S | VSC™ Band with 70° Curved Blunt Needle, single |
| CFMB-001 | VSC™ Band with 70° Curved Blunt Needle, 5-pack |
| CFSB-002S | VSC™ Band with Short Blunt 58° Needle, single |
| CFMB-002 | VSC™ Band with Short Blunt 58° Needle, 5-pack |
All configurations supplied sterile.
Kit components
Box 1CFMB-002
Bands (5×)
Box 2CFSP-01XX
Buttress plate (1×)
Box 3CFIK-TEMP
Ribbon template (1×)
Box 4CFIK-INST(Optional)
Company
Experienced med-device leadership team
CircumFix Solutions is a Collierville, Tennessee company built on decades of orthopedic and medical device experience, with a lean, outsourced model for engineering, manufacturing and regulatory work.
Louis Houff
President & CEO35+ years of sales and executive leadership in the orthopedic medical device industry, including Synthes and Smith & Nephew.
Josh Gustafson, MD
Chief Medical OfficerCardiothoracic surgeon at Brooke Army Medical Center, JBSA–Fort Sam Houston, Texas.
Ken Richardson
VP & COO25+ years of marketing, sales and operations leadership in orthopedics, including Integra LifeSciences, Smith & Nephew, Stryker and Synthes.
Eric Breese
CFO25+ years of corporate finance, investment and M&A experience. CPA, MBA.
10
US patents issued
EP · JP
European and Japanese patents granted
2024
FDA 510(k) clearance, January 2024
Trademarks: CircumFix™ · CircumFixator™ · CircumFixation™ · VariTrax™ · VSC™
Contact
Bring VariTrax™ to your hospital
Talk with us about product evaluation, value analysis, ordering or a printed IFU.
Order by phone(901) 221-7094
Emailcontact@circumfix.com
YouTube@CircumFixSolutions
Address224 Grand Steeple Drive, Collierville, TN 38017