SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM

K962789 · Smith & Nephew Endoscopy, Inc. · GEY · Aug 14, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962789
• Device Name: SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: GEY · General, Plastic Surgery
• Decision Date: Aug 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The components of the MosaicPlasty System are intended to be used for drilling bone, harvesting osteochondral bone grafts and transferring grafts to the drilled site.

Device Story

MosaicPlasty System is a manual orthopedic surgical instrument kit; includes drill guides, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, and adapters. Used by surgeons in clinical/OR settings to harvest and transplant osteochondral bone grafts. Instruments facilitate precise drilling, graft extraction, and graft placement into recipient sites. Stainless steel construction; manual operation. Benefits include standardized instrumentation for autograft transfer procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence based on design, material, and functional comparison to predicate devices.

Technological Characteristics

Manual orthopedic surgical instruments. Materials: Stainless steel. Dimensions: 2.7 mm to 4.5 mm diameter. Components: Drill guide, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, adapters. Sterilization: Tray included for sterilization.

Indications for Use

Indicated for orthopedic surgical procedures requiring bone drilling, harvesting of osteochondral bone grafts, and transfer of grafts to a recipient site.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Drill Guide (Synthes)
• Drill Bits (Synthes)
• Gouges (Synthes)
• Trephine Drills (Smith & Nephew Endoscopy)
• Tamps (Zimmer)
• Bone Grafter (Instrument Makar)
• Bone Compression Forceps (KMedic)

Submission Summary (Full Text)

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510(K) SUMMARY
K962789

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K962789

This summary was prepared on August 9, 1996

AUG 14 1996

## A. Submitter

Smith & Nephew Endoscopy
130 Forbes Boulevard
Mansfield, MA 02048

Establishment Registration Number: 1219602

## B. Company Contact

Tedd Gosian
Clinical / Regulatory Manager

## C. Device Name

Trade Name: MosaicPlasty® System
Common Name: Drill Bits, Chisels, Trephines, Tamps, Drill Guide
Classification Name: Orthopedic Manual Surgical Instruments, Template

## D. Predicate/Legally Marketed Devices

All of the components in the MosaicPlasty System are Class I Exempt Devices, except drill bits and adapters which are Class I.

Predicate/Legally Marketed Devices include:

Drill Guide Synthes®
Drill Bits Synthes®
Gouges Synthes®
Trephine Drills Smith & Nephew Endoscopy
Tamps Zimmer®
Bone Grafter Instrument Makar®
Bone Compression Forceps KMedic®

## E. Device Description

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K962789
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The MosaicPlasty System is a kit composed of several orthopedic manual surgical instruments. These instruments include a drill guide, drill guide plugs, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressor, drill bit adapters and a sterilizing tray. All instruments are composed of stainless steel. The instruments range in diameter from 2.7 mm to 4.5 mm.

## F. Intended Use

The components of the MosaicPlasty System are intended to be used for drilling bone, harvesting osteochondral bone grafts and transferring grafts to the drilled site.

## G. Substantial Equivalence

The components of the MosaicPlasty System are Class I exempt devices, except drill bits and adapters which are Class I. The components are similar in design, function, materials and intended use as other devices currently in commercial distribution. All devices are composed of stainless steel. The intended use and commercially available devices are presented in the table below.

Risks to health have been addressed through the specified materials, processing controls, quality assurance, and compliance to the Medical Device Good Manufacturing Practices regulations.

| Intended Use | Current Product MosaicPlasty Component | Substantially Equivalent Product |
| --- | --- | --- |
| Drill Template | Drill Guide | Drill Guide (Synthes®) |
| Use with Template | Drill Plugs | Drill Sleeves (Synthes) |
| Drilling in Bone | Drill Bits | Drill Bits (Synthes) |
| Harvesting Bone Grafts | Tubular Chisels | Gouges (Synthes) |
| Cutting circular bone section | Trephines | Trephine Drills (Smith & Nephew Endoscopy) |
| Tamping Graft into site | Tamps | Tamps (Zimmer®) |
| Transferring bone graft to recipient site | Transfer Tubes | Bone Gratter (Instrument Makar®) |
| Adapting drill bit or trephine to orthopedic drill | Trephine Adapters (Quick Coupling, Power) | Quick Coupling Adapter (Synthes) |
| Compress bone block | Bone Plug Compressor | Bone Compression Forceps (KMedic®) |

Applicant _Tedd Q. Jones_ Date _8/9/96_