K Number
K203855
Device Name
CoNextions TR Tendon Repair System
Manufacturer
Date Cleared
2022-04-22

(477 days)

Product Code
Regulation Number
878.4495
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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)
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.
More Information

No
The device description and performance studies focus on a mechanical implant for tendon repair and do not mention any AI or ML components or functionalities.

Yes
The device is intended for the repair of severed tendons, which is a therapeutic intervention.

No

This device is a tendon repair system, which is a therapeutic device used for the physical repair of severed tendons, not for diagnosing conditions.

No

The device description explicitly states it consists of a physical implant made of stainless steel and UHMWPE fiber, along with an Implant Mechanism and Deployment Mechanism, which are hardware components.

Based on the provided information, the CoNextions TR Tendon Repair System is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for the repair of severed tendons in adults. This is a surgical procedure performed in vivo (within the living body).
  • Device Description: The device is an implant consisting of anchors and fiber, designed to be placed within the body to physically connect severed tendons.
  • Lack of Diagnostic Function: The description does not mention any function related to examining specimens (like blood, tissue, or urine) outside the body to provide diagnostic information.
  • Performance Studies: The performance studies focus on the clinical outcomes of the surgical repair (re-rupture rates, mobility, pain, strength), not on the accuracy or reliability of a diagnostic test.

IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to examine specimens and provide information for the diagnosis, monitoring, or treatment of a disease or condition. The CoNextions TR Tendon Repair System is a surgical implant used for a therapeutic purpose in vivo.

N/A

Intended Use / Indications for Use

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)

Product codes (comma separated list FDA assigned to the subject device)

GAQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Digital Flexor Tendons, Digital Extensor Tendons Proximal to the Metacarpophalangeal Joint (Zones 6-8)

Indicated Patient Age Range

Adults (22 years of age or older).

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

  • 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
  • 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 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. A standardized rehabilitation protocol was implemented during the first 12 weeks post-procedure. Participants and therapists performing outcome assessments were blinded for 12 weeks post-procedure, with final follow-up at 24 weeks.
  • Sample Size: 90 participants screened, 81 included in final analysis after exclusions (40 in CoNextions TR group, 50 in Suture group randomized; 34 in CoNextions TR group, 47 in Suture group for safety outcomes; and varying N for effectiveness outcomes).
  • Primary Safety Outcome: Incidence of re-rupture of the repaired Zone 2 FDP tendon laceration. Target safety criterion: rate of re-rupture of 8% or less at 12-week follow-up. At 12 weeks, 1 of 33 (3.0%) in CoNextions TR group experienced rupture vs. 5 of 45 (11.1%) in Suture group. For all study participants (presumably 24 weeks), 1 of 34 (2.9%) in CoNextions TR group and 5 of 47 (10.6%) in Suture group experienced rupture.
  • Secondary Safety Outcomes: Surgical site infection. For participants who experienced surgical site infection and/or completed 24-week follow-up, 1 of 34 (2.9%) in CoNextions TR group vs. 4 of 47 (8.5%) in Suture group experienced surgical site infection. Total adverse events: 26 of 34 (76.5%) in CoNextions TR group vs. 37 of 47 (78.7%) in Suture group. Serious adverse events: 4 of 34 (11.8%) in CoNextions TR group vs. 7 of 47 (14.9%) in Suture group. No statistically significant differences were seen between the two groups for these safety outcomes.
  • Primary Effectiveness Outcome: Mobility of the repaired digit(s) using Strickland's Revised scores. Target effectiveness criterion: at least 80% of CoNextions TR repairs achieving a Strickland Score of 50% or better at 12-week follow-up. This goal was not met. At 12 weeks, 11 of 27 (40.7%) participants in CoNextions TR group and 18 of 41 (43.9%) participants in Suture group had Strickland Score of 50% or better. Average Strickland Score at 12 weeks: 47.8% (CoNextions TR) vs. 44.0% (Suture). At 24 weeks, 18 of 30 (60.0%) CoNextions TR vs. 24 of 42 (57.1%) Suture had Strickland Score of 50% or better. Average Strickland Score at 24 weeks: 52.7% (CoNextions TR) vs. 50.0% (Suture). No statistically significant differences were seen between the two groups.
  • Secondary Effectiveness Outcomes: VAS Pain Scores, DASH Questionnaire Scores, Grip Strength, and Tip Pinch Strength. No statistically significant differences between the two groups for these outcomes at any time point, with differences being less than the reported minimal clinically important difference.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Safety Outcomes:

  • Rupture of Repair: CoNextions TR 1/34 (2.9%), Suture 5/47 (10.6%)
  • Surgical Site Infection: CoNextions TR 1/34 (2.9%), Suture 4/47 (8.5%)
  • At Least One Adverse Event: CoNextions TR 26/34 (76.5%), Suture 37/47 (78.7%)
  • At least One Serious Adverse Event: CoNextions TR 4/34 (11.8%), Suture 7/47 (14.9%)

Digital Mobility Outcomes:

  • Strickland Score of At Least 50% at 12 Week Follow-up: CoNextions TR 11/27 (40.7%), Suture 18/41 (43.9%)
  • Average Strickland Mobility Score at 12 Week Follow-Up (95% CI): CoNextions TR 47.8% (40.50, 55.10), Suture 44.0% (36.10, 51.90)
  • Strickland Score of At Least 50% at 24 Week Follow-up: CoNextions TR 18/30 (60.0%), Suture 24/42 (57.1%)
  • Average Strickland Mobility Score at 24 Week Follow-Up (95% CI): CoNextions TR 52.7% (44.96, 55.10), Suture 50.0% (41.94, 58.06)

Secondary Effectiveness Outcomes at 24 Weeks (Average, 95% CI):

  • VAS Pain Score: CoNextions TR 1.2 (0.5, 1.8), Suture 1.0 (0.5, 1.6)
  • DASH Questionnaire Scores: CoNextions TR 12.3 (7.7, 17.0), Suture 11.5 (6.5, 16.5)
  • Tip Pinch Strength as a % of Contralateral Digit: CoNextions TR 73.2% (63.2, 83.3), Suture 79.4% (72.8, 86.0)
  • Grip Strength as a % of Contralateral Hand: CoNextions TR 68.7% (61.8, 75.5), Suture 73.1% (66.1, 80.2)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K023594, K946173

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K041553, K930591, K946173

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4495 Stainless steel suture.

(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

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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. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K203855 CoNextions Medical CoNextions TR Tendon Repair System

Applicant Information

| Manufacturer: | CoNextions Medical
150 North Wright Brothers Drive, Suite 560
Salt Lake City, Utah 84116
Ph: 385.351.1461
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,
Sterile |
| Classification Name: | Stainless Steel Suture |
| Regulatory Class: | Class II |
| Product Code: | GAQ |
| Predicate Devices: | K023594, Teno FixTM Tendon Repair System, Ortheon Medical, LLC.
(Primary)
K946173, PROLENETM Polypropylene Nonabsorble Suture, Ethicon,
Inc. |
| Reference Devices: | K041553, Arthrex Fiberwire, Arthrex, Inc.
K930591, TiCronTM Suture, Tyco Healthcare Group LP
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 CategorySpecific Tests Performed
Performance TestingDeployment Reliability
Static Tensile Testing
Cyclic Tensile Testing
Glide Evaluation Testing
Implant Extraction Testing
Biocompatibility TestingToxicologic Risk Assessment
Cytotoxicity
Sensitization
Irritation
Pyrogenicity Testing
Acute Toxicity
Subacute Toxicity
Subchronic Toxicity
Intramuscular implantation
Genotoxicity

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Testing CategorySpecific Tests Performed
Sterilization ValidationSterilization Validation
EO residual testing
Endotoxin (LAL) validation
MR CompatibilityInduced Displacement Testing
Induced Torque Testing
Induced Heating Testing
Image Artifact Testing
PackagingPackage Integrity Testing
Accelerated Aging Testing
Animal TestingTwo-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 CriteriaExclusion Criteria
1. At least 18 years of age
  1. Willing and able to provide a
    signed and dated informed
    consent form.
  2. Stated willingness to comply with
    all study procedures
  3. Available for the duration of the
    study
  4. Have one or two fully lacerated
    digital FDP tendon(s), with or
    without a concomitant injury of the
    flexor digitorum superficialis, in
    Zone 2 of the index, middle, ring,
    or small finger
  5. Tendon laceration occurred within
    the previous 14 days | 1. Pregnant or planning to become pregnant
    during the follow-up period
  6. Autoimmune disorder(s)
  7. Type 1 diabetes mellitus or clinical history of
    poorly controlled Type 2 diabetes mellitus
  8. Lack of proper cutaneous coverage at repair
    site
  9. Concomitant fracture
  10. Amputated digit(s)
  11. Arthritis of the hand
  12. Prior hand trauma with residual impact to
    function
  13. Congenital hand defect
  14. Conditions that would affect comparative
    measurements in the uninjured hand
  15. Tendon laceration caused by a crush injury
  16. Prior sensory impairment in digits of either
    hand. Note: Participants with nerve injuries
    associated with the trauma causing the
    current flexor tendon injury are eligible for
    enrollment
  17. Vascular injuries that require
    revascularisation procedures
  18. Ischemia and/or blood supply compromise
  19. Prior or current infections at or near the
    tended implant site |

Table 1. Enrollment Criteria for Clinical Evaluation of CoNextions TR Tendon Repair System

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Inclusion CriteriaExclusion Criteria
16. Active sepsis, MRSA, or other conditions
that may prevent healing
17. History of foreign-body sensitivity to 316 L
Stainless Steel or UHMWPE
18. Implantation of CoNextions TR Implant
would result in physical contact with other
metal implants made of material other than
implant grade stainless steel such as
titanium, titanium alloys, cobalt chromium, or
other dissimilar metals
19. Any condition(s) which, in the opinion of the
investigator, may impact the participant's
ability to properly follow-up or otherwise be
at-risk for following protocol instructions
20. Currently participating in another
clinical/device trial
21. Surgical site access less than 20 mm in total
or less than 10 mm on either side of the
intended implant site
22. Injured tendon outside of the width range
(3.0-7.0 mm) and thickness range (1.5-4.0
mm) specified for the CoNextions TR
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 OutcomeCoNextions TRSuture
Rupture of Repair1/34 (2.9%)5/47 (10.6%)
Surgical Site Infection1/34 (2.9%)4/47 (8.5%)
At Least One Adverse Event26/34 (76.5%)37/47 (78.7%)
At least One Serious Adverse Event4/34 (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
TR | Suture |
|---------------|----------------------------------|------------------|---------------|
| Pain | Participants with AE (Y/N,
%) | 14/34 (41.2%) | 21/47 (44.7%) |
| | Total number AE | 44 | 52 |
| Stiffness | Participants with AE (Y/N,
%) | 16/34 (47.1%) | 21/47 (44.7%) |

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| Adverse Event | | CoNextions
TR | Suture |
|-------------------------------------------------|----------------------------------|------------------|--------------------------------------|
| | Total number AE | 28 | 31 |
| Swelling | Participants with AE (Y/N,
%) | 13/34 (38.2%) | 21/47 (44.7%) |
| | Total number AE | 24 | 34 |
| Neuralgia | Participants with AE (Y/N,
%) | 10/34 (29.4%) | 16/47 (34.0%) |
| | Total number AE | 18 | 21 |
| Adhesion | Participants with AE (Y/N,
%) | 2/34 (5.9%) | 2/47 (4.3%) |
| | Total number AE | 2 | 2 |
| Rupture of Repair | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 5/47 (10.6%) |
| | Total number AE | 1 | 6 |
| Septic Surgical Site Infection | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 1/47 (2.1%) |
| | Total number AE | 2 | 1 |
| Scarring of Surgical Incision | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 4/47 (8.5%) |
| | Total number AE | 1 | 4 |
| Flexion
Deformity/Contracture | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 1/47 (2.1%) |
| | Total number AE | 1 | 1 |
| Delayed Healing of Incision | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 2/47 (4.3%) |
| | Total number AE | 1 | 2 |
| Hyperextension of Repaired
Digit | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 0/47 (0.0%) |
| | Total number AE | 1 | 0 |
| Device Positioned Incorrectly
During Surgery | Participants with AE (Y/N,
%) | 1/34 (2.9%) | 0/47 (0.0%) |
| | Total number AE | 1 | 0 |
| Other AE not seen in
CoNextions TR Group | Participants with AE (Y/N,
%) | 0/34 (0/0%) | (1-6)/47
(Range of 2.1-
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 EventCoNextions TRSuture
RuptureParticipants with AE (Y/N, %)1/34 (2.9%)5/47(10.7%)
Total number AE16
Septic Surgical Site
InfectionParticipants with AE (Y/N, %)1/34 (2.9%)1/47 (2.1%)
Total number AE21
Device PositionedParticipants with AE (Y/N, %)1/34 (2.9%)0/47 (0.0%)
Table 4. Serious Adverse Events Affecting the Injured Digit(s)
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Serious Adverse EventCoNextions TRSuture
IncorrectlyTotal number AE10
Hyperextension
injury of injured
fingerParticipants with AE (Y/N,
%)1/34 (2.9%)0/47 (0.0%)
Total number AE10
Superficial Surgical
Site InfectionParticipants with AE (Y/N,
%)0/40 (0.0%)1/47 (2.1%)
Total number AE01
Flexion DeformityParticipants with AE (Y/N,
%)0/40 (0.0%)1/47 (2.0%)
Total number AE01
Post-surgical Nerve
EntrapmentParticipants with AE (Y/N,
%)0/40 (0.0%)1/47 (2.1%)
Total number AE01

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
TR | Suture |
|-------------------------------------------------------------------------|-------------------------|-------------------------|
| Strickland Score of At Least 50% at 12
Week Follow-up (Yes/Total, %) | 11/27 (40.7%) | 18/41 (43.9%) |
| Average Strickland Mobility Score at 12
Week Follow-Up (95% CI) | 47.8%
(40.50, 55.10) | 44.0%
(36.10, 51.90) |
| Strickland Score of At Least 50% at 24
Week Follow-up (Yes/Total. %) | 18/30 (60.0%) | 24/42 (57.1%) |
| Average Strickland Mobility Score at 24
Week Follow-Up (95% CI) | 52.7%
(44.96, 55.10) | 50.0%
(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

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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

OutcomeCoNextions TRSuture
VAS Pain Score at 24 Weeks
(N, Average, 95% CI)N=33N=42
1.21.0
(0.5, 1.8)(0.5, 1.6)
DASH Questionnaire Scores at 24 Weeks (N,
Average, 95% CI)N=33N=42
12.311.5
(7.7, 17.0)(6.5, 16.5)
Tip Pinch Strength at 24 Weeks as a % of
Contralateral Digit
(N, Average, 95% CI)N=32N=40
73.2%79.4%
(63.2, 83.3)(72.8, 86.0)
Grip Strength at 24 Weeks as a % of
Contralateral Hand
(N, Average, 95% CI)N=33N=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.