ReConnex Pre-Sutured Tendon

K170957 · Allosource · GAT · Mar 20, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K170957
• Device Name: ReConnex Pre-Sutured Tendon
• Applicant: Allosource
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Mar 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

Device Story

ReConnex™ Pre-Sutured Tendon consists of cleaned, disinfected allograft tendons (anterior tibialis, posterior tibialis, peroneus longus, semitendinosus, or gracilis) pre-sutured with Force Fiber UHMWPE nonabsorbable surgical suture. Device is terminally sterilized via electron beam irradiation. Used by orthopedic surgeons in operating rooms for ACL and PCL reconstruction. Pre-sutured construct eliminates manual suturing of tendon bundles in the OR, providing a biomechanically equivalent alternative to surgeon-prepared bundles. Benefits include standardized construct preparation and reduced surgical time. Output is a ready-to-implant tendon construct.

Clinical Evidence

No clinical trials were performed. Evidence includes bench testing (tensile strength, suture pull-out, knot pull strength), bacterial endotoxin testing (USP <85>, USP <161>, ANSI/AAMI ST72:2011), and a cadaver feasibility study. The cadaver study (n=not specified) demonstrated no statistical difference in biomechanical performance between the pre-sutured construct and surgeon-prepared quadruple bundles. Literature review supported the use of the specified tendon types for ACL reconstruction.

Technological Characteristics

Construct comprises allograft tendons and UHMWPE nonabsorbable surgical suture. Sterilized via low-dose electron beam irradiation. Single-patient use. Bacterial endotoxin levels meet <20 EU per device. Complies with AATB requirements and 21 CFR Parts 820 and 1271 for tissue processing.

Indications for Use

Indicated for patients requiring anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstruction using allograft tendon constructs.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). 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.

Predicate Devices

• Arthrex Suture Grafting Kit (K041553)

Reference Devices

• Force Fiber UHWMPE Non-absorbable Surgical Suture (K092533)

Submission Summary (Full Text)

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March 20, 2018

AlloSource Trevor Wright Director, Regulatory Affairs 6278 S. Troy Circle Centennial, Colorado 80111

Re: K170957

Trade/Device Name: ReConnex™ Pre-Sutured Tendon Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: GAT Dated: February 13, 2018 Received: February 14, 2018

Dear Mr. Wright:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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### Page 2 - Trevor Wright

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K170957

Device Name:

Indications for Use:

Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

Prescription Use _ X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Submitted by: | AlloSource<br>6278 S. Troy Circle<br>Centennial, CO 80111 USA<br>Telephone: [phone]<br>Facsimile: 720-873-0212 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Trevor Wright |
| Date Prepared: | March 20, 2018 |
| Proprietary Name: | ReConnex™ Pre-Sutured Tendon |
| Common Name: | Pre-Sutured Tendon |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) surgical suture<br>(21 CFR 878.5000)<br>GAT |
| Predicate Device: | Arthrex Suture Grafting Kit<br>510(k) # K041553 |
| Reference Device: | Force Fiber UHWMPE Non-absorbable Surgical Suture<br>510(k) # K092533 |

This 510(k) Summary information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

#### Device Description

This device consists of a combination of tendons that have been cleaned and disinfected using a proprietary process. The tendons are pre-sutured and terminally sterilized by low dose electron beam irradiation. The device may include anterior tibialis, posterior tibialis, peroneus longus, semitendinosus and/or gracilis tendons and is pre-sutured with Force Fiber UHWMPE nonabsorbable surgical suture. Through a contractual agreement with Teleflex Medical, AlloSource has the license rights to manufacture pre-sutured tendons using their UHMWPE non-absorbable surgical suture cleared 15-Sept-2009 under pre-market clearance K092533. All products are provided sterile and for single patient use.

#### Intended Use of Device

Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

#### Technological Characteristics and Substantial Equivalence

The predicate device that received market clearance under K041553 is a suture kit intended to be incorporated as a component into surgical constructs including allograft tissues used for repair. The components of the proposed ReConnex™ pre-sutured tendon device are equivalent to the device described in K041553 in that tendon allografts are sutured together with UHMWPE sutures to generate a surgical construct for the soft tissue reconstruction described above. Therefore, AlloSource concludes based on the intended use described in K041553 that our ReConnex™ presutured tendon is considered substantially equivalent to the predicate device cleared 10-Dec-2004.

Donors meet eligibility requirements for all relevant communicable diseases via a medical director review of donor medical and social history and all applicable infectious disease screening tests, including human immunodeficiency virus type 1 (HIV-1 and HIV-1 NAT), human immunodeficiency virus type 2 (HIV-2), hepatitis B virus (HBV NAT, HBcAb and HBsAg), hepatitis C virus (HCV and HCV-NAT), and syphilis (Rapid Plasma Reagin or Serologic Test for Syphilis). The tissue recovered from each individual donor is processed as an individual batch in a segregated manner to avoid

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cross contamination with other donor tissue. The donor tissue utilized meets the requirements of the American Association of Tissue Banks (AATB) and 21 CFR Parts 820 and 1271.

#### Product Performance Testing

Visual characteristics and tensile strength of the pre-sutured tendons were evaluated and are equivalent to or better than the tensile strength data for the predicate device cleared under K041553. The suture does not pull out when subjected to pull testing, and the suture knot pull strength is equivalent to or better than USP Non-absorbable Surgical Sutures average knot pull strength.

#### Cadaver Feasibility Testing

A cadaver study was conducted to demonstrate the feasibility of using the ReConnex™ pre-sutured tendon construct for ACL reconstruction, and that the construct is equivalent to, or better than a quadruple bundled construct sutured by the surgeon at the time of the results of the human cadaver knee ACL reconstruction show that biomechanically, there is no statistical difference between a sutured tendon bundle constructed in the operating room using allograft tendons, and a pre-sutured tendon constructed by AlloSource. It was also shown that ReConnex™ pre-sutured tendon construct can be implanted using traditional clinical methods by an orthopedic surgeon.

#### Literature Review

A literature review provided significant data regarding the use of individual tendons, and sutured tendon bundles in ACL reconstruction, but provided limited data specific to clinical outcome. The literature supports the combination of any two tendon types, i.e. gracilis, semitendinosus, anterior tibialis, posterior tibialis, or peroneus longus to produce the sutured tendon bundles. The number of strands is limited to a maximum of four strands as is commonly seen in a quadruple bundle. Testing performed and referenced in the literature shows that sutured tendon bundles of any of the tendon types referenced are suitable for ACL reconstruction.

#### Bacterial Endotoxin Testing

Bacterial Endotoxin Testing was conducted in accordance with the following standards:

- USP chapter <85>, Bacterial Endotoxin Test ●
- USP chapter <161>, Transfusion And Infusion Assemblies And Similar Medical Devices ●
- ANSI/AAMI ST72:2011, Bacterial endotoxins Test methods, routine, monitoring, and ● alternatives to batch testing
- . FDA Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers

Each final Reconnex™ Pre-sutured Tendon device is tested using a representative sample which has been shown to be an acceptable and representative test sample for bacterial endotoxin testing. The final construct and its associated sample were tested to ensure they met the BET requirement of 20 EU per Device.

#### Conclusion

The components of the proposed ReConnex™ pre-sutured tendon device, which includes the reference device cleared under K092533, are equivalent to the device covered under K041553 in that tendon allografts are sutured together with UHMWPE sutures. Product safety and performance are adequately supported by the substantial equivalence information and test results.