SUTURE LOCK

{0} K964935 FEB 25 1997 # Section 8: 510(k) Summary of Safety and Effectiveness | 8.1 Statement | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. | | --- | --- | | 8.2 Submitter | Smith and Nephew Endoscopy, Inc. 130 Forbes Blvd. Mansfield, Ma. 02048 | | 8.3 Company Contact | Susan Finneran Clinical/Regulatory Affairs (508) 261-3772 | | 8.4 Device Name | Proprietary Name: Suture-Lock Common Name: Suture Retention Device/ Accessory to Suture Classification Name: Suture Retention Device | | 8.5 Predicate Legally Marketed Devices | T-Fix Suture Bar Smith and Nephew Endoscopy, Inc. Mansfield, Ma. | | 8.6 Device Description | The Suture Lock is a sterile, single-use device manufactured from polyacetal. | 051 {1} 052 8.7 Intended Use The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. 8.8 Device Indications The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures. 8.9 Substantial Equivalence The Suture Lock is substantially equivalent to the T-Fix Suture Bar which is currently manufactured and distributed by Smith and Nephew Endoscopy, Inc. (Mansfield, Ma.) The table following summarizes the common features of the T-Fix suture Bar and the Suture Lock. Table 4: Substantial Equivalence | Product Name | Suture Lock | T-Fix | | --- | --- | --- | | Product Labeling | Sterile (EtO), Single Use | Sterile (EtO), Single Use | | Materials | Polyacetal | Polyacetal | | Intended use | Soft tissue fixation by securing suture | Soft tissue fixation by securing suture | | Indications | Arthroscopic and open shoulder lesion repair | Arthroscopic and open shoulder lesion repair | Applicant Susan Zinn Date 12/9/96