Patient Risk Information | Lapiplasty® 3D Bunion Correction™ (2024)

At Treace Medical Concepts, Inc., our mission is to advance the standard of care for the surgical management of bunions and related midfoot deformities. We offer

• the Lapiplasty® 3D Bunion Correction System®, which surgeons may use to correct bunions
• the Adductoplasty® System, which surgeons may use to correct midfoot deformities
• the Hammertoe PEEK Fixation System, which surgeons may use to correct hammertoe, claw toe, and mallet toe deformities, and
• other ancillary products which surgeons may use in foot and ankle surgeries

The decision to undertake surgery is not one to be taken lightly. Results of surgery will vary due to numerous factors, including but not limited to age, weight, health, prior activity levels, and other variables. Not all patients are candidates for our products or procedures. Only your doctor can advise if Lapiplasty® 3D Bunion Correction System®, the Adductoplasty® System, the Hammertoe PEEK Fixation System, or other Treace products (referred to below as the “Procedures”) are appropriate for your specific condition.

The information provided below, as well as throughout www.Lapiplasty.com, is available for your review in preparation for your consultation with a trained surgeon. We encourage you to read the information on the risks associated with the Procedures and discuss any questions you may have with your doctor so that you can make an informed decision as to whether the Lapiplasty® 3D Bunion Correction® or other Procedure is right for you.

What are the risks associated with Lapiplasty® and other Procedures?^1-5

Individual results and activity levels after surgery vary and depend on many factors including age, weight, health, prior activity level, and other variables. There are risks and recovery times associated with surgery. Risks of the Procedures include but are not limited to the following:

• Infection
• Adverse reactions to a foreign body
• Pain, discomfort, or abnormal sensations due to the presence of the implant
• Loosening, bending, cracking, or fracture of the implants
• Loss of fixation of bone
• Delayed/loss of correction or loss of anatomic position with nonunion or malunion
  • Nonunion is when a fractured bone has been unable to heal
  • Malunion is when a fracture has healed in an abnormal or less-than-optimal position
• Migration of the implant or loosening of the implant
• Delayed correction in alignment of the bones
• Decrease in bone density
• Bursitis or inflammation of the bursa sac which provides cushion and aids in reducing friction between tissues
• Revision surgery or removal of the implants

You are not a candidate for the Lapiplasty® Procedure if the following applies:

• Pediatric patient aged less than 12 years of age
• Adolescent patients aged between 12-21 years of age where the implant will cross open growth plates in skeletally immature patients

As with any surgical procedure, you are not a candidate for surgery if any of the following apply:

• Active infection
• Blood supply limitations, obesity, and insufficient quantity or quality of bone
• Mental or neurologic conditions preventing compliance with postoperative care instructions
• Known sensitivity to implantation of a foreign body or the implant materials
  • Where material sensitivity is suspected, testing is to be completed prior to implantation of the device

Please consult your surgeon if any of the above circ*mstances exist.

As outlined above, only a doctor can advise if any of the Procedures is right for you. Please consult with your doctor for a complete understanding of the associated risks of the surgery including, but not limited to, the risks outlined here, and anticipated implant duration and possible outcomes. To do so, you may follow this link to Find a Doctor who performs the Procedures.*

What are the postoperative care considerations with surgical implants?

Proper postoperative care in accordance with your surgeon’s instructions is key to a successful recovery. There are limitations of the implants used in the Procedures, and failure to comply with prescribed physical activity instructions has been implicated in premature failure of similar devices. For further information on the recovery process, follow this link to Recovery Information. Please consult your surgeon for a full understanding of the postoperative care associated with the Lapiplasty® Procedure or other Procedure.

References

1. Treace Medical Concepts Plating System Instructions for Use (LBL 1405-9005)
2. Treace Medical Concepts Compression Implant System (09-00005L)
3. Treace Medical Concepts Screw Fixation System Instructions for Use (LBL 1405-9056)
4. Treace Medical Concepts Snap-Off Screw System Instructions for Use (LBL 1405-9110)
5. Treace Medical Concepts Hammertoe Fixation System Instructions for Use (LBL 1405-9203)

* By clicking search, you understand and agree that: (1) Treace Medical Concepts, Inc. provides this listing as a service, and we have no vested interest in any specific surgeons, nor do we provide any recommendation, assurance, or guarantee with respect to their service; (2) the surgeons identified in this listing are surgeons who have completed an in-person Lapiplasty®System training course, have not paid a fee to be listed, are identified by their geographic proximity to the location you enter, and may or may not be paid consultants of Treace Medical; and (3) you are responsible for making an independent determination of the qualifications of these surgeons and whether these surgeons suit your particular needs and expectations.

This information about Lapiplasty® and other Procedures is of a general nature and does not represent orconstitute medical advice or recommendations and is for general education purposes only. The information includes descriptions of a medical device that a foot surgeon may choose for patients undergoing bunion or midfoot correction surgery.

Treace Medical Concepts, Inc. offers medical devices, including implants, that may be used by your surgeon for the foot surgery. We do not practice medicine; all questions regarding your medical condition must be directed to your doctor(s).

For product experience feedback, call 904-373-5940 or email pe@treace.net.