Early Weight-Bearing After the Lapiplasty Procedure

Each subject will undergo the Lapiplasty® Procedure. The key surgical steps of the
Lapiplasty® Procedure are releasing the 1st TMT joint, anatomical correction of the 3-plane
deformity, bone preparation using the Lapiplasty® Cut Guide , provisional fixation and
multiplanar permanent fixation with the BIPLANAR™ Plate.

It is common for people who undergo a Lapidus Arthrodesis to be non-weight-bearing for 6-8
weeks following the surgical procedure. This time allows the bones to properly fuse together.
During this 6-8 week period, people can be limited in the typical day-to-day activities they
participate in, such as walking, shopping and working.

The Lapiplasty® System Implants may allow subjects to bear weight earlier than traditional
procedures without negatively effecting healing/union of the joint. By allowing people to
bear weight earlier than traditional methods, it is possible that people will have the
opportunity to resume typical day-to-day activities faster than usual.

This study will investigate the Lapiplasty® Procedure and the Lapiplasty® System Implants
with early weight-bearing. The study preference is that subject will be placed in a walking
CAM boot and allowed to start protected weight bearing no later than 3 weeks after surgery.
Subject can begin protected bearing weight in a CAM boot as early as the day of surgery.
Subject will return to weight-bearing in shoe (running or another athletic shoe) and full
unrestricted activity as directed by the physician based on the clinical stability and
subject ability to safely begin weight-bearing and unrestricted activities.

Recommended Approach for Post-Operative Care and Weight-Bearing Instructions

- Subject may be either bandaged, put in splint/cast or put in CAM boot at the time of
surgery. If subject is fitted with CAM boot at discharge, the patient should be provided
instructions on how to begin protected weight-bearing.

- Subject is instructed to remain off the operative foot as much as possible for the first
few days post-op. This is to limit bleeding and swelling and to allow soft tissues to
recover.

- Subject may leave the surgery facility with crutches, walker, rolling knee scooter or
wheelchair.

- At the first post-op visit (0-3 weeks), bandages are removed, and the subject can be
allowed to shower. Subject may wear an athletic sock. No bandages or splints are needed.
The subject should be reminded of post-op care of the foot/surgical site.

- At the first post-op visit (0-3 weeks), the subject is fitted with a CAM boot (if the
subject was not fitted for a CAM boot at discharge). Subject should be provided with
instructions on how to begin protected weight-bearing in the CAM boot and acceptable
activities:

- Patient is instructed to put weight on foot as tolerated in the restrictive boot.

- Patient is instructed not to roll forward onto the big toe and should remain on
flat foot.

- Patient is instructed to remove the CAM boot multiple times daily and perform range
of motion exercises for ankle and foot.

- At the 6 week post-op visit, if the subject is clinically stable, subject can transition
from the boot to a shoe (running or another athletic shoe). The transition from boot to
shoe may occur over a period of days/weeks, depending on subject healing and tolerance.
Subject is instructed that they can walk normally but are not to stand on toes, run,
jump or do any other high impact activity

- At the 4 month post-op visit, subject is allowed to begin low impact exercise if they
are clinically stable.

Inclusion Criteria:

1. Male and females between the ages 18 and 55 years at the time of consent

2. Closed physeal plates at the time of consent

3. Intermetatarsal angle is between 10.0 ̊ - 22.0 ̊

4. Hallux valgus angle is between 16.0 ̊ - 40.0 ̊

5. Willing and able to adhere to early weight-bearing instructions post-operatively

6. Capable of completing self - administered questionnaires

7. Acceptable surgical candidate, including use of general anesthesia

8. Female patients must be of non-child bearing potential or have a negative pregnancy
test within 7 days prior to index procedure

9. Willing and able to schedule index procedure within 3 months of consent and able to
return for scheduled follow-up visits

10. Willing and able to provide written informed consent

Exclusion Criteria:

1. Previous surgery for hallux valgus on operative side

2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other
than hammertoe or lesser toes/digits)

3. Additional arthrodesis outside the first tarsometatarsal joint (other than:
arthrodesis between the medial cuneiform and intermediate cuneiform and/or base of 2nd
metatarsal; arthrodesis of hammertoe proximal interphalangeal joint or lesser
toes/digits)

4. Moderate or Severe osteoarthritis of the MTP joint based on radiographic imaging
(including lack of evident crista) or positive grind test

5. Symptomatic flatfoot or asymptomatic flatfoot (defined as calcaneal inclination <5
̊and talonavicular subluxation/uncovering >50%)

6. BMI >40 kg/m²

7. Current nicotine user, including current use of nicotine patch

8. Current clinical diagnosis of diabetes with fasting plasma glucose > 126 mg/dL and/or
HbA 1c ≥7.0

9. Current clinical diagnosis of peripheral neuropathy or by assessment on 4 - point
monofilament test

10. Current clinical diagnosis of fibromyalgia

11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic
Dystrophy (CRPS/RSD)

12. Current uncontrolled hypothyroidism

13. Previously sensitized to titanium

14. Currently taking oral steroids or rheumatoid biologics

15. Currently taking immunosuppressant drugs

16. Insufficient quantity or quality of bone to permit stabilization, conditions that
retard healing (not including pathological fractures) and conditions causing poor
blood supply such as periheral vascular disease

17. Active, suspected or latent infection in the affected area

18. Use of synthetic or allogenic bone graft substitutes

19. Current diagnosis of metatarsus adductus (defined as MAA ≥ 23 ̊)

20. Scheduled to undergo a same - bilateral procedure. Patient agrees to refrain from the
Lapiplasty® Procedure (or other hallux valgus procedures) on contralateral foot for
minimum of 6 months post index procedure

21. Patient has previously been enrolled into this study for a contralateral procedure

22. Scheduled for any concomitant procedure that would alter patient's ability to early
weight-bear post-procedure

23. Patient is actively involved with a workman's compensation case or is currently
involved in litigation

24. Patient is currently or has participated in a clinical study in the last 30 days prior
to signing informed in survey clinical studies with no treatment is not an exclusion
criterion

25. Patient has a condition or finding that, in the opinion of the Investigator, may
jeopardize the patient's well-being, the soundness of this clinical study, or could
interfere with provision of informed consent, completion of tests, therapy, or
follow-up