HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)

K955733 · Depuy, Inc. · HWC · Nov 18, 1996 · Orthopedic

Device Facts

• Record ID: K955733
• Device Name: HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED)
• Applicant: Depuy, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phantom PLLA Interference Screw is an absorbable interference fixation screw.

Device Story

Absorbable interference fixation screw; used for bone-tendon-bone patellar graft fixation. Device features fully threaded cancellous bone screw design; available in 7.0mm, 8.0mm, 9.0mm diameters; lengths 15-30mm; cannulated and non-cannulated versions. 9mm tip tapered for self-tapping; square drive insertion; headless, low-profile design. Radiolucent on X-ray; visible via MRI/CAT. Used by surgeons in orthopedic procedures to secure graft within drill tunnel via interference fit. Benefits include absorbable material, eliminating need for secondary removal surgery; low profile minimizes subcutaneous protrusion.

Clinical Evidence

No clinical data provided; device equivalence based on design, material, and intended use comparisons to predicate devices.

Technological Characteristics

Material: PLLA (Poly L-Lactic Acid) absorbable polymer. Design: Fully threaded, headless, cancellous bone screw. Sizes: 7.0mm, 8.0mm, 9.0mm diameters; 15-30mm lengths. Features: Cannulated/non-cannulated options, self-tapping tip (9mm), square drive interface. Radiolucent on X-ray; MRI/CAT compatible.

Indications for Use

Indicated for bone-tendon-bone patellar graft fixation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• BioScrew® Fixation System (K933719)
• M. Kurosaka Interference Screw (K933798)
• Biologically Quiet Interference Screw (K943249)

Submission Summary (Full Text)

{0}

11/15/96 FRI 13:28 FAX [phone]
002
NOV 18 1996

# K955733

## X. SUMMARY OF SAFETY AND EFFECTIVENESS

### SAFE MEDICAL DEVICES ACT OF 1990
### 510(k) Summary

**NAME OF FIRM:** DePuy Inc
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988

**FIRM CONTACT:** Steve Wentworth
Regulatory Affairs Manager
Tel. No. [phone]

**TRADE NAME:** Phantom™ PLLA Interference Screw

**COMMON NAME:** Bone/Tendon/Bone Screw

**CLASSIFICATION:** Smooth or threaded bone fixation fastener; 888.3040

**DEVICE PRODUCT CODE:** 87 HWC

**SUBSTANTIALLY EQUIVALENT DEVICES:**

- BioScrew® Fixation System (Linvatec) - K933719
- M. Kurosaka Interference Screw (DePuy) - K933798
- Biologically Quiet Interference Screw (Instrument Makar) - K943249

**DEVICE DESCRIPTION AND INTENDED USE:**

The Phantom PLLA Interference Screw is an absorbable interference fixation screw. The DePuy DuPont Phantom™ Interference Screw is a fully threaded cancellous bone screw available in 7.0mm, 8.0mm and 9.0mm diameter sizes. Each diameter is available in either 15, 20, 25, and 30mm lengths and is offered in cannulated and non-cannulated versions.

The tip of the 9mm sized screw is tapered to a point which produces the self tapping feature of the screw. The screw is inserted by a square drive which is broached into the minor diameter of the screw body. The headless, low profile design minimizes subcutaneous surface protrusions. The threads are a symmetrical thread form designed to equally match stiffness between bone and thread. The Phantom screw is radiolucent on x-rays, but can be visualized with MRI and CAT scans.

{1}

11/15/96 FRI 13:28 FAX [phone]
003

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The Phantom™ Interference Screw, M. Kurosaka Interference Screw and the BioScrew® are intended to provide bone-tendon-bone patellar graft fixation, employing the same principles of graft fixation. These fixation screws provide an interference fit engaging both the drill tunnel and the bone plug of the graft. The Phantom™ Interference Screw is substantially equivalent to the M. Kurosaka Screw with respect to design and intended use and is substantially equivalent in material, design and intended use to the Bioscrew.

Both the Phantom™ Interference Screw and the Bioscrew® are manufactured from PLLA (Poly L-Lactic Acid) absorbable polymers and the M. Kurosaka/Advantage Screw is manufactured from Ti-6Al-4V alloy. All three screws are headless and fully threaded. The BioScrew® is offered in a cannulated version only. The M. Kurosaka Interference Screw and the Phantom™ Interference Screw are offered in both cannulated and non-cannulated versions.

[e-mail]