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Zimmer, Inc.

Chondrofix® Osteochondral Allograft

Chondrofix Osteochondral Allograft

Chondrofix Osteochondral Allograft transforms the repair of full-thickness osteochondral lesions to a new level of convenience. Chondrofix Allograft is the first off-the-shelf osteochondral allograft. Each graft combines inherent qualities of donor human bone and cartilage with the advantages of simplicity and safety. It is intended for homologous use to repair osteochondral lesions in diarthrodial joints....

Composed of donated human decellularized hyaline cartilage and cancellous bone, Chondrofix Allograft possesses relevant mechanical properties that are comparable to unprocessed osteochondral tissue.

During the proprietary processing, original characteristics of the osteochondral tissue, such as cartilage thickness and stiffness, are retained. Chondrofix Allograft is an option for patients who experience knee pain and seek early and innovative treatment from a sports medicine specialist.

Chondrofix Allograft delivers mechanical stability, structure and osteoconductivity to a knee compromised by Grade III or Grade IV osteochondral lesions and concomitant injuries. The Chondrofix Allograft process does not compromise the graft’s ability to endure the load demands of the active patient. The Chondrofix Allograft is able to withstand immediate post-operative weight bearing, while healing takes place.Unlike cell based therapies that may require longer-term progressive rehabilitation protocols, typically, the Chondrofix Allograft patient is at full weight bearing 6-8 weeks post-surgery.

Give your patients the advantages of allograft tissue without a waiting period. With processing that includes viral inactivation and terminal sterilization steps, Chondrofix Allograft is ready for use. There is no wait.

Simplicity and Versatility

Each Chondrofix Allograft may be used alone or in multiples, providing the surgeon with significant treatment flexibility. Implantation occurs in a single surgical procedure.

Simple Safe Readily Available
Single-stage procedure Less-invasive than osteochondral autograft transplantation Off-the-shelf product
Four pre-cut sizes to accommodate lesions of varying sizes and shapes (diameters of 7mm, 9mm, 11mm, and 15mm) No donor site morbidity 24-month shelf life
Grafts pre-cut in 10mm lengths Processing includes terminal sterilization and viral inactivation steps Single-use sterile instruments

Contact your Zimmer sales representative for more details on Chondrofix Osteochondral Allograft.

Surgical Techniques and Related Guides

Chondrofix Osteochondral Allograft features an innovative manufacturing process. As a minimally manipulated human tissue graft,the Chondrofix Allograft undergoes a proprietary processing protocol resulting in a shelf-stable graft that retains relevant inherent structural properties and provides an effective alternative to fresh allograft or autograft for the repair of osteochondral lesions. The process has been validated to remove lipids and to provide a sterility assurance level (SAL) of 10-6.Additionally, the Chondrofix Allograft processing includes a viral inactivation step, tested against a panel of AATB and FDA recommended viruses, which contributes to the product’s safety.

Stability in the Knee

Each Chondrofix Allograft features a layer of decellularized hyaline cartilage atop cancellous bone. Chondrofix Allograft Instrumentation was engineered and designed to provide a specific interference fit that delivers graft stability in the recipient site, while decreasing the required impaction forces.

Chondrofix Allograft has a cylindrical design, which enhances contact with bone, stability and load-bearing capability.

Physical Properties Yield Positive Results for Patients with Knee Pain

Relevant structural properties of Chondrofix Allograft have been tested and compared with non-processed osteochondral tissue.

Results indicate:

  • Comparable relevant mechanical properties (e.g., bone and cartilage compressive moduli)
  • Comparable coefficient of friction
  • Comparable water content

Processing Offers Protection

Chondrofix Allograft is aseptically processed in a controlled environment at LifeNet Health, a leader in bio-implants. The graft undergoes a proprietary processing protocol, which includes lipid removal, viral inactivation and terminal sterilization steps. Lipid removal creates a bone scaffold that is conducive to bone integration and remodeling, while reducing the risk of inflammation. The viral inactivation step has been shown to provide a 3-5.6 log reduction in a FDA and AATB recommended panel of relevant viruses, decreasing the potential risk of infection to the recipient.This panel includes viruses that model clinically relevant viruses (see table below for details).Chondrofix Allograft is terminally sterilized via low temperature low dose gamma irradiation.

Viral Inactivation Log Reduction

Model Virus Relevant Virus Enveloped Genome Log10 Reduction
Bovine viral diarrhea virus (BVDV) Hepatitis C (HCV) Yes RNA >5.1*
- Hepatitis A (HAV) No RNA >3.1
- HIV-1 Yes RNA >3.3*
Porcine Parvovirus (PPV) Parvovirus B19 No DNA 5.6
Pseudorabies Virus (PrV) Herpes Viruses Yes DNA >5.5*

*Virus reduced to non-detectable levels

Note: Due to the presence of residual methylene blue, a reagent used during the viral inactivation processing step, the graft and storage solution will have a blue or blue/green coloration.

Unsurpassed Shelf Stability and Availability

The product is terminally sterilized and can be stored for 24 months at less than 40°C, but it must not be frozen. Each graft is 10mm in length, and is available in four diameters:

  • 7mm
  • 9mm
  • 11mm
  • 15mm

Note: 7mm, 9mm and 11mm can be implanted arthroscopically or via a mini-arthrotomy; 15mm should only be implanted via a mini-arthrotomy.

Ease of Implantation

Chondrofix Allograft is implanted in a single-stage procedure. In any given case, surgeons may utilize multiple grafts of the same or varying sizes. Specialized single-use instruments provide ease of use in arthroscopic (7mm, 9mm and 11mm sizes) or in mini-arthrotomy (7mm-15mm) procedures.

Because the product is readily available in multiple sizes, surgeons may use varied configurations of Chondrofix Allografts to cover lesions of different sizes and shapes.

Note: Multi-graft implantation (mosaicplasty constructs) is not recommended without proper shouldering of the surrounding host tissue.

 

Contact your Zimmer sales representative for more details on Chondrofix Osteochondral Allograft.

Chondrofix Osteochondral Allograft is intended for the repair of osteochondral lesions in diarthrodial joints. Fresh osteochondral tissue is used to repair Grade III or Grade IV defects in the knee; therefore, Chondrofix Allograft is recommended to repair Grade III and Grade IV osteochondral lesions, including those that are surgically created. It is well suited for a wide range of patient populations experiencing osteochondral lesions and concomitant injuries. The product may be an attractive option for active patients.

Chondrofix Allograft is a donated human tissue graft that is regulated by the FDA in the same manner as other orthopedic allograft materials such as meniscus allografts, bone allografts and fresh osteochondral allografts for cartilage repair. It is designated as a ‘361’ HCT/P as specified in 21 CFR §1271.10.

Contraindications

The graft should not be implanted when an active infection is present at the surgical site.

Warnings and Precautions

  • The graft may contain trace amounts of processing agents (methylene blue, methylene chloride, ethanol, phosphate buffered saline). Caution must be exercised if the patient has a known sensitivity to these chemicals.
  • The tissue may transmit infectious agents.
  • Do not re-sterilize or reuse the graft. Discard any opened, unused grafts.
  • Do not use the graft if its package integrity has been compromised.
  • Do not use the graft if damaged or expired.

Reimbursement

Questions regarding reimbursement may be addressed by contacting the Zimmer Reimbursement Hotline:

Phone: 1-866-946-0444

Email: reimbursement@zimmer.com

Zimmer Reimbursement Hotline Hours: Monday-Friday, 8am-5pm EST

Reimbursement Kit

To order Chondrofix Osteochondral Allograft, contact your Zimmer sales representative.

 

Contact your Zimmer sales representative for more details on Chondrofix Osteochondral Allograft.