Radiographic recurrence of hallux valgus deformity at 24 months for subjects with successful correction (defined as Intermetatarsal Angle (IMA) <9.0°, Hallux Valgus Angle (HVA)<15.0° and Tibial Sesamoid Position (TSP) as ≤ 3 at 6 weeks post-Lapiplasty® Procedure). Recurrence is defined by any two of the following three criteria being met at 24 months post-procedure: IMA of ≥12°, HVA ≥20° and TSP ≥4

Company decision to close study early due to change in commercialization strategy.

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].

Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.

Union vs non-union -- Non-union defined as lucency at TMT joint, hardware failure and/or loss of correction, plus clinical pain at first TMT joint

Company decision to close study early due to change in commercialization strategy. Due to early termination and study subjects who may not have returned for follow up visits only the number of study subjects with 12-month data at the time of study termination was analyzed.

Clinical complications due to Lapiplasty® System Implants, the procedure, the post-op weight-bearing protocol or health conditions that could affect other outcome measures - measured by Adverse Events and Product Complaint data

Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. There were 11 study subjects who had a total of 12 adverse events with one being a serious adverse event.

Time to start weight-bearing in a boot, in days

Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.

Time to start weight-bearing in a shoe

Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.

Time to return to full unrestricted activity, in days

Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.

Change in pain assess via Visual Analog Scale (VAS), scale values 0-10, 0 indicates no pain and 10 indicates the worse possible pain. Assessed at 0-2 weeks, 2-3 weeks, 6 weeks, 4 months, 6 months, 12 months, and 24 months post Lapiplasty® Procedure, 6 weeks, 4 months, 6 months, 12 months, and 24 months reported.

Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105.

1st MTP dorsiflexion and plantarflexion

Only 75 study subjects analyzed at 12 months and 11 study subjects at 24 months due to sponsor termination of study.

Each question has five response categories ranging in value from 1 to 5. The min and max response within each question is 1 and 5, respectively. The total raw score is calculated as the sum of the values of the responses to each question. The total raw score is then translated into a T-score for each participant. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Higher scores within the Physical Function and the Ability to Participate in Social Roles/Activities domains indicate better patient-reported health status. Lower scores within the Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, and Pain Intensity indicate better patient-reported health status.

Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. Of the 105-analysis population there were 6 pediatric subjects and 99 adult subjects. Only 1 pediatric study subject reached the 24 month follow up visit and therefore the change from baseline values are not estimable.

This instrument has 16 questions, each question has 5 response categories with scoring 0 to 4 where 0 represents the least problems and 4 represents greatest problems. The min and max response within each question is 0 and 4, respectively. The maximum possible raw score for the Walking/Standing domain is 28. The maximum possible raw score for the Pain domain is 20. The maximum possible raw score for the Social Interaction domain is 16. Scores for each domain are calculated separately, as the sum of each individual item (raw) score within that domain. In each case, this is then converted to a metric of 0 - 100 (higher score representing greater severity). Scores for the MOXFQ Index are initially calculated as the sum of all 16 individual item (raw) scores (maximum possible raw score 64). This is then converted to a metric of 0 - 100 (higher score representing greater severity).

Of the 108 study subjects who had a study index procedure, 3 of these study subjects were intra-operative screen failures leaving an analysis population of 105. Of the 105-analysis population there were 6 pediatric subjects and 99 adult subjects. Only 1 pediatric study subject reached the 24 month follow up visit and therefore the change from baseline values are not estimable.

Change in radiographic foot length compared to baseline visit.

Measured in 75 study subjects at 12 mo due to early study termination by the sponsor.

Change in radiographic foot width (mm) compared to baseline visit

Measured in 75 study subjects at 12 mo due to the early termination by the sponsor.

Change in swelling as compared to 0-14 day visit.

Due to missed visits or missed assessments the number of study subjects analyzed is different than the overall number analyzed.

Change in scar quality in comparison to baseline visit. 1 equals the lowest score indicating normal skin to 10 the highest score indicating largest difference from normal skin of the 6 components on the scale. Total score can range from 6 to 60 by calculating the sum of all 6 components.

98 of the 105 overall study subjects analyzed is due to missed visits and/or missed assessments.

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].

Tibial Sesamoid Position (TSP) was graded from 1-7 and defined as the position of the medial sesamoid in relation to the longitudinal anatomic axis of the first metatarsal on AP radiographs based on the Hardy and Clapham classification. Lower TSP values (<4) represent anatomic sesamoid reduction and triplanar correction. The importance of sesamoid reduction in maintenance of correction and patient outcomes has been published.

Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.

Change in radiographic angular/positional alignment before and after the Lapiplasty® Procedure [Time Frame: pre-operatively, 6 weeks, 4 months, 6 months, 12 months, and 24 months, post-Lapiplasty® Procedure].

Company decision to close study early due to change in commercialization strategy. The number of subjects analyzed at each study time point is based on assessments collected and number of subjects who returned for follow up visits. Not all study subjects returned for all study timepoint follow up visits nor could all study subjects complete the study due to early termination of the study due to sponsor commercialization strategy.