CoNextions TR Tendon Repair System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 22, 2022 CoNextions Medical % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street. Suite 2300 Philadelphia, Pennsylvania 19103 Re: K203855 Trade/Device Name: CoNextions TR Tendon Repair System Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAQ Dated: October 12, 2021 Received: October 12, 2021 Dear Janice Hogan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Kimberly Ferlin -S for Deborah Fellhauer, RN, BSN Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203855 Device Name CoNextions TR Tendon Repair System Indications for Use (Describe) CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications: - Digital Flexor Tendons · Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8) Type of Use (Select one or both, as applicable) | <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |-----------------------------------------------------------------------------------------| | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) SUMMARY K203855 CoNextions Medical CoNextions TR Tendon Repair System ## Applicant Information | Manufacturer: | CoNextions Medical<br>150 North Wright Brothers Drive, Suite 560<br>Salt Lake City, Utah 84116<br>Ph: 385.351.1461<br>F: 801.436.5369 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Matthew Swift, Director of Clinical Research | | Date Prepared: | March 18, 2022 | | Device Information | | | Name of Device: | CoNextions TR Tendon Repair System | | Common Name: | Suture, Nonabsorbable, Steel, Monofilament and Multifilament,<br>Sterile | | Classification Name: | Stainless Steel Suture | | Regulatory Class: | Class II | | Product Code: | GAQ | | Predicate Devices: | K023594, Teno FixTM Tendon Repair System, Ortheon Medical, LLC.<br>(Primary)<br>K946173, PROLENETM Polypropylene Nonabsorble Suture, Ethicon,<br>Inc. | | Reference Devices: | K041553, Arthrex Fiberwire, Arthrex, Inc.<br>K930591, TiCronTM Suture, Tyco Healthcare Group LP<br>K946173, ETHIBOND® Suture, Ethicon, Inc. | #### Device Description The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement. {4}------------------------------------------------ ## Indications for Use CoNextions TR is intended for the repair of lacerated or severed tendons in adults (22 years of age or older). The product is intended for the following indications: - Digital Flexor Tendons - Digital Extensor Tendons Proximal to the Metacarpophalangeal Joint (Zones 6-8) ## Summary of Technological Characteristics Anchoring components are placed in the two lacerated tendon ends and securely connected together and represent the essential technological principles for both the subject and predicate devices. At a high level, the subject and predicate devices are based on the following same technological elements: - Anchor Components: Portion of implant intended to fixate into lacerated tendon . ends: - . Connection: Portion of implant that secures the two anchoring com ponents togetherand bridges the repair site. The following technological differences exist between the subject and predicate devices: - Different form factor for anchoring components; . - . Different delivery method for implantation. Benchtop, animal, and clinical testing, including comparative testing to nonabsorbable polymer sutures, demonstrate the CoNextions TR is substantially equivalent and introduces no new or different questions of safety and effectiveness. #### Nonclinical/Bench Performance Data The following nonclinical/bench testing was conducted for CoNextions TR Implant System. | Testing Category | Specific Tests Performed | |--------------------------|-----------------------------| | Performance Testing | Deployment Reliability | | | Static Tensile Testing | | | Cyclic Tensile Testing | | | Glide Evaluation Testing | | | Implant Extraction Testing | | Biocompatibility Testing | Toxicologic Risk Assessment | | | Cytotoxicity | | | Sensitization | | | Irritation | | | Pyrogenicity Testing | | | Acute Toxicity | | | Subacute Toxicity | | | Subchronic Toxicity | | | Intramuscular implantation | | | Genotoxicity | {5}------------------------------------------------ | Testing Category | Specific Tests Performed | |--------------------------|------------------------------| | Sterilization Validation | Sterilization Validation | | | EO residual testing | | | Endotoxin (LAL) validation | | MR Compatibility | Induced Displacement Testing | | | Induced Torque Testing | | | Induced Heating Testing | | | Image Artifact Testing | | Packaging | Package Integrity Testing | | | Accelerated Aging Testing | | Animal Testing | Two-week Canine Study | | | Twelve-week Ovine Study | ## Summary of Clinical Information Study Overview: A clinical evaluation was conducted at 4 sites with 5 fellowship-trained hand surgeons in order to compare the safety and effectiveness of the CoNextions TR System to a standard of care suture repair method (4-strand locked cruciate repair using PROLENE suture) for the repair of lacerations of the flexor digitorum profundus (FDP) tendon in Zone 2. Participants were randomized intraoperatively following confirmation of meeting all of the inclusion criteria. A standardized rehabilitation protocol was implemented during the first 12 weeks post-procedure. The participants and therapists performing the majority of the outcome assessments were blinded to the assigned treatment arm for the 12 weeks postprocedure with the final follow-up occurring 24 weeks post-procedure. Ninety (90) participants were screened, met the study enrollment criteria (Table 1), and were randomized in to the study with 40 (40/90, 44.4%) participants randomized to the CoNextions TR group and 50 (50/90, 55.6%) participants randomized to the suture group. 8 participants were excluded from the final analysis as they were less than 22 years of age at the time of enrollment and an additional participant was excluded after suffering an injury to their affected limb unrelated to the study that could have impacted the outcome assessments. Of the remaining 81 participants, 72 (72/81, 88.9%) of them provided outcome data at the 12 week follow-up visit and 70 (70/81, 86.4%)) of them provided outcome data at the 24 week follow-up visit. | Inclusion Criteria | Exclusion Criteria | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. At least 18 years of age<br>2. Willing and able to provide a<br>signed and dated informed<br>consent form.<br>3. Stated willingness to comply with<br>all study procedures<br>4. Available for the duration of the<br>study<br>5. Have one or two fully lacerated<br>digital FDP tendon(s), with or<br>without a concomitant injury of the<br>flexor digitorum superficialis, in<br>Zone 2 of the index, middle, ring,<br>or small finger<br>6. Tendon laceration occurred within<br>the previous 14 days | 1. Pregnant or planning to become pregnant<br>during the follow-up period<br>2. Autoimmune disorder(s)<br>3. Type 1 diabetes mellitus or clinical history of<br>poorly controlled Type 2 diabetes mellitus<br>4. Lack of proper cutaneous coverage at repair<br>site<br>5. Concomitant fracture<br>6. Amputated digit(s)<br>7. Arthritis of the hand<br>8. Prior hand trauma with residual impact to<br>function<br>9. Congenital hand defect<br>10. Conditions that would affect comparative<br>measurements in the uninjured hand<br>11. Tendon laceration caused by a crush injury<br>12. Prior sensory impairment in digits of either<br>hand. Note: Participants with nerve injuries<br>associated with the trauma causing the<br>current flexor tendon injury are eligible for<br>enrollment<br>13. Vascular injuries that require<br>revascularisation procedures<br>14. Ischemia and/or blood supply compromise<br>15. Prior or current infections at or near the<br>tended implant site | Table 1. Enrollment Criteria for Clinical Evaluation of CoNextions TR Tendon Repair System {6}------------------------------------------------ | Inclusion Criteria | Exclusion Criteria | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 16. Active sepsis, MRSA, or other conditions<br>that may prevent healing | | | 17. History of foreign-body sensitivity to 316 L<br>Stainless Steel or UHMWPE | | | 18. Implantation of CoNextions TR Implant<br>would result in physical contact with other<br>metal implants made of material other than<br>implant grade stainless steel such as<br>titanium, titanium alloys, cobalt chromium, or<br>other dissimilar metals | | | 19. Any condition(s) which, in the opinion of the<br>investigator, may impact the participant's<br>ability to properly follow-up or otherwise be<br>at-risk for following protocol instructions | | | 20. Currently participating in another<br>clinical/device trial | | | 21. Surgical site access less than 20 mm in total<br>or less than 10 mm on either side of the<br>intended implant site | | | 22. Injured tendon outside of the width range<br>(3.0-7.0 mm) and thickness range (1.5-4.0<br>mm) specified for the CoNextions TR<br>Tendon Repair System | Primary Safety Outcome: The primary safety endpoint of the study was the incidence of re-rupture of the repaired Zone 2 FDP tendon laceration. Repaired digits were evaluated at all post-procedure follow-up visits for signs and symptoms of the repair. The target safety criterion was a rate of re-rupture of 8% or less at the 12 week follow-up visit, At the 12 week follow-up visit. 1 of 33 (3,0%) participants in the CoNextions TR group experienced a rupture with 5 of 45 (11.1%) participants in the Suture group experiencing a rupture. For all study participants, 1 of 34 (2.9%) participants in the CoNextions TR group and 5 of 47 (10.6%) participants in the Suture group who experienced a rupture. Secondary Safety Outcomes: Surgical site infection was assessed at all follow-up visits as a secondary safety outcome. For the study participants who experienced a surgical site infection and/or completed the 24 week follow-up visit, one (1) of 34 (2.9%) participants in the CoNextions TR group experienced a surgical site infection with 4 of 47 (8.5%) participants in the Suture group experiencing a surgical site infection. Twenty-six (26) of 34 (76.5%) participants in the CoNextions TR group and 37 of 47 (78.7%) participants in the Suture group experienced at least one adverse event Four (4) of 34 (11.8%) participants in the CoNextions TR group and 7 of 47 (14.9%) participants in the Suture group experienced a serious adverse event. No statistically significant differences were seen between the two groups for these safety outcomes (Table 2). | Table 2. Safety Outcomes for the Clinical Evaluation | | | |------------------------------------------------------|---------------|---------------| | Safety Outcome | CoNextions TR | Suture | | Rupture of Repair | 1/34 (2.9%) | 5/47 (10.6%) | | Surgical Site Infection | 1/34 (2.9%) | 4/47 (8.5%) | | At Least One Adverse Event | 26/34 (76.5%) | 37/47 (78.7%) | | At least One Serious Adverse Event | 4/34 (11.8%) | 7/47 (14.9%) | | Table 2, Safety Outcomes for the Clinical Evaluation | | |------------------------------------------------------|--| |------------------------------------------------------|--| **Notes:** All values are presented as Participants with Safety Outcome/Total Participants, % Adverse Events: There were 155 total adverse events (AE) in the CoNextions TR group with 29 (18.7%) of them not affecting or related to the injured digit(s), A listing of all adverse events related to the injured digit(s) for both study groups is shown in Table 3. | Adverse Event | | CoNextions<br>TR | Suture | |---------------|----------------------------------|------------------|---------------| | Pain | Participants with AE (Y/N,<br>%) | 14/34 (41.2%) | 21/47 (44.7%) | | | Total number AE | 44 | 52 | | Stiffness | Participants with AE (Y/N,<br>%) | 16/34 (47.1%) | 21/47 (44.7%) | {7}------------------------------------------------ | Adverse Event | | CoNextions<br>TR | Suture | |-------------------------------------------------|----------------------------------|------------------|--------------------------------------| | | Total number AE | 28 | 31 | | Swelling | Participants with AE (Y/N,<br>%) | 13/34 (38.2%) | 21/47 (44.7%) | | | Total number AE | 24 | 34 | | Neuralgia | Participants with AE (Y/N,<br>%) | 10/34 (29.4%) | 16/47 (34.0%) | | | Total number AE | 18 | 21 | | Adhesion | Participants with AE (Y/N,<br>%) | 2/34 (5.9%) | 2/47 (4.3%) | | | Total number AE | 2 | 2 | | Rupture of Repair | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 5/47 (10.6%) | | | Total number AE | 1 | 6 | | Septic Surgical Site Infection | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 1/47 (2.1%) | | | Total number AE | 2 | 1 | | Scarring of Surgical Incision | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 4/47 (8.5%) | | | Total number AE | 1 | 4 | | Flexion<br>Deformity/Contracture | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 1/47 (2.1%) | | | Total number AE | 1 | 1 | | Delayed Healing of Incision | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 2/47 (4.3%) | | | Total number AE | 1 | 2 | | Hyperextension of Repaired<br>Digit | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 0/47 (0.0%) | | | Total number AE | 1 | 0 | | Device Positioned Incorrectly<br>During Surgery | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 0/47 (0.0%) | | | Total number AE | 1 | 0 | | Other AE not seen in<br>CoNextions TR Group | Participants with AE (Y/N,<br>%) | 0/34 (0/0%) | (1-6)/47<br>(Range of 2.1-<br>12.8%) | | | Total number AE | 0 | 28 | Notes: Adverse events related to Weakness, superficial surgical site infection, bleeding at surgical site, serious fluid drainage, triggering, dermatiis, blister/burn, post-surgical nerve entrapment, epidermal in wound, and cellulitis were observed in the Suture group but not in the CoNextions TR group There were no significant differences in the two study groups related to the frequency of any adverse events. Pain, stiffness, swelling, and neuralgia of the repair sites were the most common adverse events seen in both groups, accounting for 74 of the 126 (58.7%) adverse events affecting the injured digit(s) in the CoNextions TR group. These are known and common adverse events experienced in the postoperative recovery following the surgical repair of lacerated tendons. Adhesion, another known complication following the surgical repair of lacerated tendons is the only other adverse event affecting the injured digit(s) which occurred in more than one participant in the CoNextions TR group (occurring in 2/34 participants, 5.9%). Serious Adverse Events: All (5) of the serious adverse events (SAE) in the CoNextions TR group affected the injured digit(s). None of these events occurred in more than one participant in the CoNextions TR group. A listing of all serious adverse events related to the injured digit(s) for both study groups is shown in Table 4. | Serious Adverse Event | | CoNextions TR | Suture | |-----------------------------------|-------------------------------|---------------|-------------| | Rupture | Participants with AE (Y/N, %) | 1/34 (2.9%) | 5/47(10.7%) | | | Total number AE | 1 | 6 | | Septic Surgical Site<br>Infection | Participants with AE (Y/N, %) | 1/34 (2.9%) | 1/47 (2.1%) | | | Total number AE | 2 | 1 | | Device Positioned | Participants with AE (Y/N, %) | 1/34 (2.9%) | 0/47 (0.0%) | | Table 4. Serious Adverse Events Affecting the Injured Digit(s) | |----------------------------------------------------------------| |----------------------------------------------------------------| {8}------------------------------------------------ | | Serious Adverse Event | CoNextions TR | Suture | |-----------------------------------------------|----------------------------------|---------------|-------------| | Incorrectly | Total number AE | 1 | 0 | | Hyperextension<br>injury of injured<br>finger | Participants with AE (Y/N,<br>%) | 1/34 (2.9%) | 0/47 (0.0%) | | | Total number AE | 1 | 0 | | Superficial Surgical<br>Site Infection | Participants with AE (Y/N,<br>%) | 0/40 (0.0%) | 1/47 (2.1%) | | | Total number AE | 0 | 1 | | Flexion Deformity | Participants with AE (Y/N,<br>%) | 0/40 (0.0%) | 1/47 (2.0%) | | | Total number AE | 0 | 1 | | Post-surgical Nerve<br>Entrapment | Participants with AE (Y/N,<br>%) | 0/40 (0.0%) | 1/47 (2.1%) | | | Total number AE | 0 | 1 | There were no significant differences in the two study groups related to the occurrence of these serious adverse events. The rupture in the CoNextions TR group was surgically repaired using a conventional suturing technique (as were the ruptures in the suture group). The CoNextions TR implant was successfully removed as part of the treatment for the septic surgical site infection. In the case of the device being positioned incorrectly in the CoNextions TR group, the implant was removed and replaced with an additional implant at the time of the original surgical repair. The hyperextension injury was a result of additional trauma, considered unrelated to the CoNextions TR device, and treated with additional surgery. Primary Effectiveness Outcome: The primary effectiveness outcome was the mobility of the repaired digit(s). Strickland's Revised scores were used to provide a descriptive measure of mobility. Strickland Scores are the sum of the active flexion angle of the interphalangeal and metacarpal joints less the extension deficit and are presentage of a normal value (175), Flexion and extension deficit values were collected using standard finger goniometry methods. Target effectiveness criterion for the study was at least 80% of the CoNextions TR repairs achieving a Strickland Score of 50% or better at the 12 week follow-up visit. This goal was not met; however the primary analysis was supplemented with posthoc analyses looking at the comparative performance of the two study groups at the final follow-up and the average Strickland mobility scores of the two groups at the 12 and 24 week follow-ups, At the 12 week follow-up, 11 of 27 (40.7%) participants in the CoNextions TR group and 18/41 (43.9%) participants in the Suture group had a Strickland Score of 50% or better. The average Strickland Scores was 47,8 for the CoNextions TR group and 44.0 for the Suture group at the 12 week follow-up. At the 24 week follow-up, 18 of 30 (60.0%) CoNextions TR participants and 24 of 42 (57.1%). Suture participants had a Strickland Score of 50% or better. The average Strickland Scores was 52.7 for the CoNextions TR group and 50.0 for the Suture group at the 12 week follow-up (Table 5). No statistically significant differences were seen between the two groups for these safety outcomes | Digital Mobility Outcomes | CoNextions<br>TR | Suture | |-------------------------------------------------------------------------|-------------------------|-------------------------| | Strickland Score of At Least 50% at 12<br>Week Follow-up (Yes/Total, %) | 11/27 (40.7%) | 18/41 (43.9%) | | Average Strickland Mobility Score at 12<br>Week Follow-Up (95% CI) | 47.8%<br>(40.50, 55.10) | 44.0%<br>(36.10, 51.90) | | Strickland Score of At Least 50% at 24<br>Week Follow-up (Yes/Total. %) | 18/30 (60.0%) | 24/42 (57.1%) | | Average Strickland Mobility Score at 24<br>Week Follow-Up (95% CI) | 52.7%<br>(44.96, 55.10) | 50.0%<br>(41.94, 58.06) | | | Table 5, Primary Effectiveness Outcome for the Clinical Evaluation | | | |--|--------------------------------------------------------------------|--|--| | | | | | Notes: An error at one site occurred early in the study and resulted in a passive mobility score being reco some participants at their 12 week follow-up visit. As a result of this error, there were more participants with active mobility scores at the 24 week follow-up then at the 12 week follow-up. Secondary Effectiveness Outcomes: VAS Pain Scores, DASH Questionnaire Scores, Grip Strength, and Tip Pinch Strength were assessed as secondary effectiveness outcomes. A 0-10 cm VAS Pain scale was used to assess the patient's self-reported pain. The DASH Questionnaire is a validated metric of functional outcome following intervention in the upper extremity. This questionnaire consists of 30 questions assessing the participants ability to perform various activities of daily living with a score range of 0 (no disability) to 100 (completely disabled). Grip Strengths were collected using a dynamometer and Tip {9}------------------------------------------------ Pinch Strengths were collected using a pinch gauge. For both strength assessments, the participant was seated with the shoulder adducted and in neutral, the elbow flexed at 90 degrees and the forearm and wrist in neutral position. Both strength assessments are presentage of the corresponding strength for the contralateral digit (Tip Pinch Strength) or contralateral hand (Grip Strength). There were no statistically significant differences between the two groups for these outcomes at any time point with any differences with any differences between the two groups being less than the reported minimal clinically important difference for the outcome measure (Table 6), | Secondary Effectiveness<br>Outcome | CoNextions TR | Suture | |-----------------------------------------------------------------------------------------|---------------|--------------| | VAS Pain Score at 24 Weeks<br>(N, Average, 95% CI) | N=33 | N=42 | | | 1.2 | 1.0 | | | (0.5, 1.8) | (0.5, 1.6) | | DASH Questionnaire Scores at 24 Weeks (N,<br>Average, 95% CI) | N=33 | N=42 | | | 12.3 | 11.5 | | | (7.7, 17.0) | (6.5, 16.5) | | Tip Pinch Strength at 24 Weeks as a % of<br>Contralateral Digit<br>(N, Average, 95% CI) | N=32 | N=40 | | | 73.2% | 79.4% | | | (63.2, 83.3) | (72.8, 86.0) | | Grip Strength at 24 Weeks as a % of<br>Contralateral Hand<br>(N, Average, 95% CI) | N=33 | N=40 | | | 68.7% | 73.1% | | | (61.8, 75.5) | (66.1, 80.2) | Table 6. Secondary Effectiveness Outcomes at Final (24 week) Follow-up ## Conclusion The CoNextions TR Tendon Repair System is as safe and effective as the predicate devices. CoNextions TR has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices, The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between CoNextions TR and its predicate devices raise no new issues of safety or effectiveness. Performance data, including comparative bench, animal, and clinical testing, demonstrate that the CoNextions TR is as safe and effective as the predicate devices. Thus, CoNextions TR is substantially equivalent.