what the system offers
|KEY FEATURES
Category: Product
Introducing the
SMART Bun-Yo-Matic℠
Discover how the SMART Bun-Yo-Matic℠ revolutionizes preoperative planning and correction for Hallux Valgus with precise patient measurements and powerful visualization tools.
Here’s what the system offers:
Allows for Powerful 3D Preoperative Planning
SMART Bun-Yo-Matic℠ can accurately create patient pre-op axes and measurements.
Upload X-ray or WBCT to generate a 3D patient specific case report in under 10 minutes*. Execute the surgical plan in the OR with Bun-Yo-Matic’s controlled correction.
Surgeons can manipulate correction, based on their preference.
*Case report generation time will be dependent upon network speed and bandwidth.
Enhances the Ability to Assess the 1st TMT Joint
Visualization of the resection of the metatarsal and cuneiform.
Identifies the Recommended Correction for Hallux Valgus
Required IMA, metatarsal de-rotation, and DMAA correction is identified.
Detects the Presence of Abnormal Anatomy
The case report identifies Metatarsus Adductus. Meary’s angle is measured and shown in the report to indicate the presence of PCFD.
Correction is Measurable with The Bun-Yo-Matic Lapidus Clamp
The IMA correction and metatarsal de-rotation identified in the case report can be identified, measured, and held in place with the Bun-Yo-Matic Lapidus Clamp.
Allows for 3D Analysis From 2D X-Rays
SMART Bun-Yo-Matic is the first foot and ankle orthopedic device on the market that allows the user to assess rotation and see the anatomy in 3D using only standard 2D AP and lateral images.
Key Features of the Bun-Yo-Matic™ Lapidus Clamp
1. Secure Attachment
- Multiple points of attachment prevent slippage and provide the surgeon with control over the foot
- Avoids key visual landmarks to enable clear interoperative fluoroscopy
2. Precision Cut Guides
- Achieve reproducible cuts through the metatarsal and cuneiform using dedicated cut guides
- Cuts are optimized to maintain length and minimize resection, based on the correction introduced by the clamp
3. Intermetatarsal Angle Correction
- Allows for the translation of the first metatarsal to reduce the intermetatarsal angle
- Provides up to 28° of intermetatarsal angle correction
4. Metatarsal De-Rotation
- Offers up to 25° of first metatarsal de-rotation angle correction Rotates around the central axis of the metatarsal for precise adjustments
5. Joint Distraction and Closure
- Facilitates distraction for joint preparation and closure for alignment and reduction using a single device
6. Multiple Fixation Options
- Compatible with Paragon 28’s extensive range of Lapidus Fixation options, including the Gorilla® Lapidus Arthrodesis System and the Phantom® Intramedullary Nail
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Product Demo Video
Frequently Asked Questions
Contact your local P28 sales representative to learn about pricing for your facility. For reimbursement information, your rep may contact the P28 National Accounts team.
Contact your sales representatives; they will be able to schedule a meeting with you to demo the software and instrumentation. Or email smart28.support@paragon28.com for more information.
Contact your local sales representative for an invitation to register for the SMART28 Case Management Portal. You may access the portal by visiting https://smart.paragon28.com/ . Your sales representative will be the first person to answer questions. Schedule a meeting with them to demo and review the SMART28 Case Management Portal.
Your local P28 sales representative is the first person to train you on the system. There will also be a few medical education courses in 2025 for training in Denver and Mobile Labs. Please visit the https://paragon28.com/events for more information.
You will need to order a weight bearing CT or weight bearing X-ray scan of the patient’s foot and upload to the SMART28 Case Management Portal via https://smart.paragon28.com/. From there, the system guides you through the SMART Bun-Yo-Matic™case planning process.
Uploading the scan takes a few minutes. After your preferred correction is finalized, it takes under 10 minutes for the SMART Bun-Yo-Matic℠ case report to populate. The whole process takes 15-20 minutes.
Currently the software is only available for Hallux Valgus. It is designed for use in tandem with the Phantom® Intramedullary Nail, Gorilla® Lapidus Plating System and other Paragon28 Lapidus related hardware.
The Phantom® Intramedullary Nail, Gorilla® Lapidus Plating System and other Paragon28 Lapidus hardware options are a common occurrence for insurers.
MAVEN™
Patient Specific Instrumentation
PATIENT SPECIFIC INSTRUMENTATION
|BENEFITS
|CLINICAL DATA
|RESOURCES
Patient Specific Instrumentation
& Surgical Planning Case Reports
FEATURING THE FIRST TO MARKET
AP Positioning
Technology
MAVEN™ Patient Specific Guides and Surgical Planning Case Reports were developed to:
- Simplify and expedite alignment
- Accurately determine both implant size selection and placement critical for long-term survivorship1
MAVEN™ Alignment Blocks Features
Tibia PSI Guide
AP Spacer Guide
Talar PSI Guide
The Maven™ PSI System…
Provides an accurate and simple-to-use technology in the palm of your hand. The Patient-Specific Guides, Surgical Planning Case Reports and Bone Models are based on individual patient anatomic structures, are generated using segments of the patient’s operative limb CT scan and are intended to contour to the patient’s anatomy.
The MAVEN™ PSI System utilizes computer assisted processing technology to achieve accurate tibiotalar alignment and implant placement to reduce potential for eccentric loads,weardebrisandosteolysis.1,2 The System was also designed to address abnormal varus or valgus alignment of the implant construct, reported to be a major cause of implant loosening3 and decreased postoperative function.4
Maven™ PSI System Guides…
- Utilizes an advanced CT based coordinate system designed for precise component alignment, accurate implant placement and size selection critical for long term survivorship5
- Are designed based on individual patient anatomic structures to ensure the Guides contour to the patient’s bone geometry not osteophytes
- Preserves periosteum and anterior talar cartilage during joint preparation due to minimal Guide/bone contact interface
- Provides secure and stable tactile feedback during initial positioning
- Are designed to preserve anatomic landmark references
- Allows for precise component positioning and establishes clearly defined bone resection planes
- The AP Positioning Spacer establishes optimal AP bone coverage
Patient-Specific Technology Based on Research
ALIGNMENT. ORIENTATION. POSITIONING.
The MAVEN PSI System utilizes surgeon inputs and computer assisted processing technology to achieve accurate tibiotalar alignment and implant placement to reduce potential for eccentric loads, wear debris and osteolysis.2, 3
Minimal Joint
Preparation Required
- Are generated based on surgeon inputs and segments of the patient’s
CT scanned anatomy - Address all 6 degrees of rotational and translational orientation
- Allow for enhanced pre-operative visualization of anatomic structures,
bone resection levels and help to identify anatomic abnormalities - Depict APEX 3D™ System Tibia & Talus Implant sizes in simulated implantation
- Surgeon’s input throughout the design process
APEX 3D™ with MAVEN® Surgical Technique Animation
APEX 3D System Brochures
Surgical Technique
RESEARCHED BASED. SOLUTION FOCUSED.
Paragon 28® APEX 3D™ Total Ankle Replacement System was designed to address end-stage ankle arthritis and current challenges within the total ankle market including: implant loosening, pathological wear, instability and persistent pain.
Find out more about the APEX 3D™ Total Ankle Replacement System
apexankle.com
References
- Insall JN, Binazzi R, Soudry M, Mestriner LA. Total knee arthroplasty. Clin Orthop Relat Res. 1985;(192):13 22
- Kurtz, S.M., Bracco, P., Costa, L., Oral, E., Muratoglu, O.K. (2016) Vitamin E-Blended UHMWPE Biomaterials. UHMWPE Biomaterials Handbook, 293-325.
- G. Rochcongar, MD, G. Buia, MD, E. Bourroux, J. Dunet, MD, V. Chapus, MD, and C. Hulet, MD, PhD. (2018) Creep and Wear in Vitamin E-Infused Highly Cross-Linked Polyethylene Cups for Total
- Hip Arthroplasty A Prospective Randomized Controlled Trial. Journal of Bone and Joint Surgery, Incorperated.
- Hvid, I. et. al. (1985) Trabecular Bone Strength Profiles at the Ankle Joint. Clinical Orthopaedics and Related Research, 306-312.
PATIENT SPECIFIC IMPLANT
|TALUS REPLACEMENT
|BENEFITS
|clinical data
|resources
Patient Specific Talus Spacer
The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating.
- The ONLY FDA Registered 3D Printed Total Talus Implants available in multiple materials
- Expected to provide PAIN RELIEF and PRESERVE MOTION of ankle joint
- Alternative to fusion or amputation
- Indicated for Avascular Necrosis of the ankle
- Patient specific technique guide provided for PRE-PLANNED anatomy correction
- MULTIPLE IMPLANT SIZES provided for intra-operative selection
- Surgeon choice of implant material
- Cobalt Chromium
- Titanium with Titanium Nitride coating
Total Talus Replacement
The Paragon 28 Patient Specific Talus Spacer is an alternative treatment option to fusion and amputation, and requires talus replacement surgery. During this procedure the native talus bone is removed and replaced with a 3D printed replica. This is considered a joint-sparing procedure, as it allows the patient to maintain motion of his/her ankle joint.
Patient Specific Talus Spacer in Multiple Materials
Explore our 3D printed, patient specific implant designed and made individually for each patient.
Paragon 28 Patient Specific Talus Spacer
The Paragon 28 Patient Specific Talus Spacer is an additively manufactured, or 3D printed, patient specific implant that is designed and made individually for each patient using CT image data.
Total Talus Replacement
An alternative treatment option to fusion and amputation, the Paragon 28 Patient Specific Talus Spacer is indicated for avascular necrosis of the ankle and requires total talus replacement surgery.
The procedure is designed to relieve pain and preserve motion in the ankle joint by replacing the patient’s damaged talus with a 3D printed replica of his/her bone. Talus replacement surgery is considered a joint sparing procedure as it allows the patient to retain motion in the ankle joint.
Potential Benefits of a Paragon 28 Patient Specific Talus Spacer
Reduce Pain
Improve Range
of Motion
Enjoy Recreational
Activities
Continue Your
Career
Better Quality
of Life
Patients who received a Paragon 28 Patient Specific Talus Spacer in the clinical study showed a reduction in baseline VAS Pain Scores, improvement in ROM, and improvement of functional outcomes based on FAOS subscales, including pain, symptom, activities of daily living, ability to perform sports and recreational activities, and foot/ankle related quality of life. Please refer to the IFU for complete Clinical Data Information.
Xiomalis’ Story
Learn More About The
Paragon 28 Patient Specific Talus Spacer
The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating. The Paragon 28 Patient Specific Talus Spacer in cobalt chromium is an additively manufactured implant made from cobalt chromium metal alloy and produced by laser sintering.
The Paragon 28 Patient Specific Talus Spacer in titanium alloy is an additively manufactured implant made from titanium alloy with a titanium nitride coating and produced by electron beam melting. The surgeon selects which material is best suited for his/her patient. The device allows the patient to regain motion and reduce pain without an amputation or fusion for the treatment of the current condition.
The Paragon 28® Patient Specific Talus Spacer has two material options: a cobalt chromium metal alloy and a titanium alloy with a titanium nitride coating. The Paragon 28 Patient Specific Talus Spacer in cobalt chromium is an additively manufactured implant made from cobalt chromium metal alloy and produced by laser sintering.
The Paragon 28 Patient Specific Talus Spacer in titanium alloy is an additively manufactured implant made from titanium alloy with a titanium nitride coating and produced by electron beam melting. The surgeon selects which material is best suited for his/her patient. The device allows the patient to regain motion and reduce pain without an amputation or fusion for the treatment of the current condition.
Clinical Data
Patients who received a Paragon 28 Patient Specific Talus Spacer in the clinical study showed a reduction in baseline VAS Pain Scores, improvement in ROM, and improvement of functional outcomes based on all FAOS subscales, including pain, symptom, activities of daily living, ability to perform sports and recreational activities, and foot/ankle-related quality of life. Please refer to the IFU for complete Clinical Data information.
VAS Pain (om) – Mean Baseline and Last Folllow Up by Duration of Folllow-up
Quality of Life
Product Resources
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