Zimmer Biomet Announces FDA Clearance of the Persona Trabecular Metal Tibia

Zimmer Biomet Holdings Inc., a global developer of musculoskeletal healthcare, announced the completion of the first surgical case utilizing its Persona Trabecular Metal (TM) Tibia by Dr. Richard Moore of Boise, Idaho, on March 20. The Persona Trabecular Metal Tibia received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in January and CE Mark approval this month. The Persona TM Tibia is an integral component of the company’s portfolio of cementless total knee arthroplasty (TKA) solutions. 
 
“Combined with the Persona TM Femur and the TM Patella, clearance of the Persona TM Tibia allows us to provide a fully cementless total knee solution, furthering our long-standing commitment to enhancing patient experiences and outcomes,” said Dan Williamson, Zimmer Biomet’s Group president of Joint Reconstruction. “We believe this innovative product will position us to re-establish our leadership in the fully cementless primary knee market.”
 
Zimmer Biomet’s proprietary TM Material is a porous biomaterial made from elemental Tantalum with structural, functional and physiological properties similar to cancellous bone.^1-3 With more than 20 years of clinical results, the company’s TM Material has been used in over 2 million orthopedic devices.
 
“The clearance of the Persona TM Tibia represents a significant step forward for those patients who can benefit from completely cementless total knee replacements that better integrate into the natural bone anatomy for durability, while possibly offering greater patient satisfaction,” said Moore.
 
The Persona TM Tibia features new drilling, sizing and insertion instrumentation that are unique to the Persona TM Tibia, while preserving all the anatomic benefits of the Persona Tibia design.^4-8

The Persona TM Tibia is another example of how the Persona System continues to redefine personalization by combining Zimmer Biomet’s 20-year porous fixation expertise with the Persona Knee family. As the company’s most comprehensive knee system, the Persona System offers more anatomically accurate components with finer increments to personalize patient fit and restore the unique identity of every knee.
 
“The TM tibial tray and pegs fit beautifully to the bone. I believe the instruments for trial prep and implant placement were a clear improvement and an advantage. I also appreciate the time efficiency of using cementless implants,” concluded Moore.

Zimmer Biomet plans a limited launch of the Persona TM Tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.
 
Founded in 1927 and headquartered in Warsaw, Ind., Zimmer Biomet designs, manufactures and markets orthopedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products. Its products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. The company has operations in more than 25 countries around the world and sell products in more than 100 countries.

References
1. Bobyn, et al., Characterization of a New Porous Tantalum Biomaterial for Reconstructive Orthopaedics. 66th Annual AAOS 1999.
2. Zhang, et al., Interfacial Frictional Behavior: Cancellous Bone, Cortical Bone, and a Novel Porous Tantalum Biomaterial. Journal of Musculoskeletal Research. 3:4, 245-251, 1999.
3. Karageorgiou and Kaplan. Porosity of Biomaterial Scaffolds and Osteogenesis. Biomaterials. 26: 5474-91, 2005.
4. Dai, et al. Anatomical Tibial Component Design Can Increase Tibial Coverage and Rotational Alignment Accuracy: A Comparison of Six Contemporary Designs. Knee Surgery Sports Traumatology Arthroscopy 22:2911–2923; KSSTA 2014.
 
5. Indelli, et al. Relationship between Tibial Baseplate Design and Rotational Alignment Landmarks in Primary Total Knee Arthroplasty. Hindawi Publishing Corporation Arthritis. Volume 2015, Article ID 189294.
 
6. Jin, et al. How Much Does the Anatomical Tibial Component Improve the Bony Coverage in Total Knee Arthroplasty. Journal of Arthroplasty. pp. 1-5; 2017.
 
7. Mizu-uchi, et al. Anatomical Shaped Tibial Baseplate Reduced Rotational Alignment Compromise in Total Knee Arthroplasty: Clinical Evaluation with Asian Knees. ORS 2017 Annual Meeting Paper No.0110. 21.Bandi, Marc, et al. Finer Femur and Insert Increments in Total Knee Arthroplasty Facilitate Accurate Balancing and Reduce the Need for Complex Techniques. Abstract number 850; ORS 2014.
 
8. Stulberg and Goyal. Which Tibial Tray Design Achieves Maximum Coverage and Ideal Rotation: Anatomic, Symmetric, or Asymmetric? An MRI-based study. Journal of Arthroplasty.  30(10): 1839, 2015.