The FDA has granted 510(k) clearance to Treace Medical Concepts, Inc., to expand indications for its Lapiplasty 3D Bunion Correction System to treat young patients over 12 years of age.
Intended Use
According to FDA documents, the system is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
The system can be used in both adult and pediatric patients.
In the foot, the system can be used for the following specific examples:
- First metatarsal osteotomies for hallux valgus correction such as:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion)
- Flatfoot osteotomies
- Lateral column lengthening (Evans Osteotomy)
- Plantar flexion opening wedge osteotomy of the medial cuneiform (cotton osteotomy)
- Mid/flatfoot fusions
- LisFranc arthrodesis and/or stabilization
- 1st (Lapidus), 2nd, 3rd, 4th, and 5th tarsometatarsal (TMT) fusions
- lntercuneiform fusions
- Navicular-cuneiform (NC) fusion
- Talo-navicular (TN) fusion
- Calcaneo-cubiod (CC) fusion
- Medial column fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
John Treace, company CEO, said, “Traditional osteotomy surgery has been associated with a high rate of recurrence thus presenting a unique concern for younger patients. The Lapiplasty Procedure has clinically demonstrated high success rates in adults, and we believe this expanded indication will provide an important new treatment option for pediatric patients seeking a more comprehensive and lasting correction of their bunion.”
The company stated that hallux valgus is a relatively common deformity of the foot in both adult and pediatric populations, affecting about 60 million Americans. “Studies indicate a prevalence of 8% to 36% in pediatrics, where the pathology is commonly linked to a hyper-mobile or unstable TMT joint that predisposes this population to developing the deformity.”
Lapiplasty Procedure
According to the company, traditional 2D osteotomies focus on addressing the cosmetic bump by shaving the protruding bone, but more than 70% of those patients say their bunion returns over time. “The Lapiplasty System uses novel guides to allow surgeons to reproducibly correct all three dimensions of the deformity and fuse the tarsometatarsal (TMT) joint. Titanium plates are then used to lock the joint in place and keep the bones in line permanently, significantly reducing the risk of recurrence. Patients are walking comfortably within days, compared to the 6-8-week recovery timeline for 2D osteotomies.”
Paul Dayton, DPM of the Midwest Bunion Center and co-developer of the system, said, “While it’s commonly taught in foot and ankle surgery that pediatric bunion treatment should address the unstable tarsometatarsal (TMT) joint to reduce the long-term likelihood of recurrence, many surgeons have been hesitant to adopt this approach due to the challenging nature of the procedure.”
The correction procedure, says the company, was developed to lower the risk of bunion recurrence by correcting all three dimensions of the bunion deformity.
“There actually is no need to cut and shift the normal metatarsal bone as with a traditional osteotomy. The entire metatarsal bone is simply rotated back into proper alignment. The unstable joint (which is the true root cause of the bunion) is then permanently secured with patented, titanium technology; allowing patients to get back on their feet quickly after surgery. Many patients are able to walk in a surgical boot after surgery within just a few days.”
“We believe this advanced technology provides a more consistent and reproducible method of permanently securing the root of the problem, an unstable joint, making the Lapiplasty Procedure my treatment of choice not only for younger patients but for any bunion patient seeking a permanent deformity correction.”
