SUTURE LOCK

K964935 · Smith & Nephew Endoscopy, Inc. · KGS · Feb 25, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964935
• Device Name: SUTURE LOCK
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: KGS · General, Plastic Surgery
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4930
• Device Class: Class 1
• Attributes: Therapeutic

Indications for 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.

Device Story

Suture-Lock is a sterile, single-use suture retention device; manufactured from polyacetal. Used by surgeons during arthroscopic and open shoulder lesion repair (Bankart and Rotator Cuff procedures). Device secures sutures to fix soft tissue to bone. Functions as an accessory to suture placement; provides mechanical retention of suture material.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Polyacetal. Sterile (EtO). Single-use. Mechanical suture retention device.

Indications for Use

Indicated for use in Bankart and Rotator Cuff Repair procedures for soft tissue to bone fixation.

Regulatory Classification

Identification

A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

Predicate Devices

• T-Fix Suture Bar

Submission Summary (Full Text)

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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
[phone] |
| 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

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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