RESORBABLE SOFT TISSUE ATTACHMENT DEVICE

K961789 · Zimmer, Inc. · MAI · Aug 1, 1996 · Orthopedic

Device Facts

• Record ID: K961789
• Device Name: RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
• Applicant: Zimmer, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications: Shoulder - Bankart lesion repairs - SLAP lesion repairs - Acromio-clavicular separations repairs - Rotator cuff tear repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - Deltoid repairs Foot and Ankle - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Hallux valgus reconstructions Elbow, Wrist, and Hand - Scapholunate ligament reconstructions - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment Knee - Extra-capsular repairs -- medial collateral ligament -- lateral collateral ligament -- posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repairs

Device Story

Resorbable soft tissue anchor; poly(L-lactic) acid construction; 12mm length, 5.0mm diameter; fully threaded; includes eyelet with USP Size No. 2 braided polyester nonabsorbable suture and two needles. Used by surgeons in orthopedic procedures; requires predrilling and tapping of bony site; insertion via disposable torque-limiting driver. Suture secures soft tissue to bone. Benefit: provides fixation strength exceeding suture strength, ensuring suture failure occurs before anchor failure.

Clinical Evidence

Bench testing only. Pullout strength evaluated in dry white pine wood and porcine bone. Results confirm anchor strength exceeds No. 2 suture strength and exceeds predicate device pullout performance.

Technological Characteristics

Material: poly(L-lactic) acid. Dimensions: 12mm length, 5.0mm diameter. Design: fully threaded anchor with proximal hex drive for torque-limiting driver. Attachment: USP Size No. 2 braided polyester nonabsorbable suture. Mechanical fixation via predrilled/tapped bone site.

Indications for Use

Indicated for soft tissue to bone suture fixation in shoulder, foot, ankle, elbow, wrist, hand, and knee procedures, including ligament and tendon repairs/reconstructions.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Resorbable Soft Tissue Attachment Device (Zimmer)
• QuickAnchor (Mitek)
• Bio-Anchor Absorbable Suture Anchor (Linvatec)
• Statak Soft Tissue Attachment Device (Zimmer)

Submission Summary (Full Text)

{0}

K 961789
AUG - 1 1996
P.O. Box 708
Warsaw, IN 46581-0708
219 267-6131

# Summary of Safety and Effectiveness

## Resorbable Soft Tissue Attachment Device, 5.0 mm Diameter

- **Submitted by**
Zimmer, Inc.
P.O. Box 708
Warsaw, Indiana 46581-0708

- **Prepared by**
Lynnette Whitaker
Manager
Regulatory Affairs

- **Date**
May 8, 1996

- **Trade Name**
Resorbable Soft Tissue Attachment Device

- **Common Name**
Resorbable Soft Tissue Anchor

- **Classification Name**
None Assigned

- **Predicate Devices**
- Resorbable Soft Tissue Attachment Device manufactured by Zimmer
- *QuickAnchor™* manufactured by Mitek

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A Bristol-Myers Squibb Company

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- Bio-Anchor™ Absorbable Suture Anchor manufactured by Linvatec
- Statak® Soft Tissue Attachment Device manufactured by Zimmer

## Device Description

The RSTA device is manufactured using poly (L-lactic) acid in a proprietary process. The anchor is a fully threaded device 12 mm in length and 5.0 mm in diameter. The anchor contains an eyelet to which a USP Size No. 2 braided polyester nonabsorbable suture and two suture needles are attached. A hex drive at the proximal end of the anchor attaches to a disposable torque limiting driver used for insertion of the anchor. The anchor requires predrilling and tapping procedures prior to implantation. Following implantation of the anchor, the free ends of the suture are used to reattach the soft tissue to the bony site.

## Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications:

### Shoulder

- Bankart lesion repairs
- SLAP lesion repairs
- Acromio-clavicular separations repairs
- Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- Deltoid repairs

### Foot and Ankle

- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Hallux valgus reconstructions

### Elbow, Wrist, and Hand

- Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions
- Tennis elbow repair
- Biceps tendon reattachment

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Knee
- Extra-capsular repairs
-- medial collateral ligament
-- lateral collateral ligament
-- posterior oblique ligament
- Iliotibial band tenodesis
- Patellar tendon repairs

Performance Data

The RSTA device was tested for pullout strength in dry white pine wood and in varying types of porcine bone. The RSTA device demonstrated strength far above that of the No. 2 suture used clinically with the device, thereby ensuring that the suture will fail prior to any portion of the anchor. Pullout testing in white pine wood and porcine bone also demonstrated superior pullout strength when compared to the predicate devices.

RA05601K.510

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