DEPUY DUPONT PHANTOM SUTURE ANCHOR

K964521 · Depuy, Inc. · MAI · Feb 6, 1997 · Orthopedic

Device Facts

• Record ID: K964521
• Device Name: DEPUY DUPONT PHANTOM SUTURE ANCHOR
• Applicant: Depuy, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Device Story

PLLA cortical screw with flat tip and rectangular head; two parallel axial holes; pre-threaded with #2 nonabsorbable polyester suture. Used in shoulder surgery for soft tissue re-attachment and capsular repair (rotator cuff, Bankart, SLAP lesions). Available in 3.5mm or 4.5mm diameters; supplied pre-loaded on driver or separate. Implanted by orthopedic surgeons in clinical/OR settings. Provides mechanical fixation for soft tissue to bone; suture secures tissue; PLLA material resorbs over time. Benefits include secure tissue re-attachment during healing.

Clinical Evidence

Bench testing only; mechanical pull-out load testing performed in cadaver bone to compare performance against Zimmer Statak.

Technological Characteristics

Material: PLLA (poly-L-lactic acid). Design: Threaded cortical screw, flat tip, rectangular head, two parallel axial holes. Dimensions: 3.5mm or 4.5mm diameter. Suture: #2 nonabsorbable polyester. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring soft tissue re-attachment and capsular repair in the shoulder, including rotator cuff, Bankart lesion, and SLAP lesion repairs.

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

• Zimmer Statak
• Acufex Suretac Absorbable Tack

Submission Summary (Full Text)

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K964521

FEB - 6 1997

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:
DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988

510(k) CONTACT:
Vickie E. Arford, R.N.
Sr. Clinical Research Associate

TRADE NAME:
DePuy DuPont Phantom Suture
Anchor

CLASSIFICATION NAME:
Smooth or threaded metallic bone fixation fastener

PRODUCT CODE:
79-JDR 87 MAI

SUBSTANTIALLY EQUIVALENT DEVICES:
Zimmer Statak
Acufex Suretac Absorbable Tack

INTENDED USE AND DEVICE DESCRIPTION:
The DePuy DuPont Phantom Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

The Phantom Suture Anchor is a PLLA cortical screw with a flat tip and a rectangular head. Two holes run parallel to the axis of the screw. A #2 nonabsorbable polyester suture is pre-threaded sequentially through these holes with a single loop at the tip of the screw. The suture anchors are available either pre-loaded on a driver or separately. The Phantom Suture Anchors are available in diameters of either 3.5 or 4.5mm.

BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy DuPont Phantom Suture Anchors are substantially equivalent to the Zimmer Statak and the Acufex Suretac in that all of these devices are suture anchors which are intended for soft tissue re-attachment in the shoulder. The Phantom Suture Anchor is a resorbable anchor manufactured from PLLA. The Acufex Suretac is a resorbable tack manufactured from polyglyconate. The Zimmer Statak is non-resorbable and is manufactured from Ti-6Al-4V metal alloy. Both the Phantom suture anchors and the Stataks have a threaded design. Mechanical testing in cadaver bone showed that the pull-out loads for the Phantom Suture Anchors were comparable to the pull-out loads for the Statak anchors.

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