ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM

K964215 · Smith & Nephew Endoscopy, Inc. · HRX · Dec 20, 1996 · Orthopedic

Device Facts

• Record ID: K964215
• Device Name: ACUFEX MOSAICPLASTY COMPREHENSIVE SYSTEM
• Applicant: Smith & Nephew Endoscopy, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Dec 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.

Device Story

MosaicPlasty Comprehensive System is a kit of manual orthopedic surgical instruments used for osteochondral grafting. Components include drill guides, drill bits, tubular chisels, trephines, tamps, transfer tubes, bone block compressors, and adapters. Used in knee and ankle arthroscopic or open procedures by orthopedic surgeons. Instruments facilitate harvesting bone grafts, preparing recipient sites, and transferring/tamping grafts into defects. Stainless steel construction. No electronic or software components.

Clinical Evidence

No clinical data provided; bench testing and comparison to legally marketed predicate devices used to establish safety and effectiveness.

Technological Characteristics

Manual orthopedic surgical instruments. Materials: Stainless steel. Dimensions: 2.7 mm to 10 mm diameter. Includes drill guides, bits, chisels, trephines, tamps, transfer tubes, and compressors. Sterilization: Sterilizing tray included. No energy source, connectivity, or software.

Indications for Use

Indicated for patients requiring arthroscopic or open osteochondral grafting to treat cartilage defects in the knee or ankle.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

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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DEC 20 1996
K964215

# 510(K) SUMMARY

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: K964215

This summary was prepared on December 16, 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: Acufex® MosaicPlasty™ Comprehensive System
Common Name: Drill Bits, Chisels, Trephines, Tamps, Drill Guide, Compression Instrument
Classification Name: Orthopedic Manual Surgical Instruments, Template Surgical Instruments Motors Accessories

## D. Predicate/Legally Marketed Devices

All of the components in the MosaicPlasty Comprehensive 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®

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# E. Device Description

The MosaicPlasty Comprehensive System is a kit composed of several orthopedic manual surgical instruments. These instruments include drill guides, 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 10 mm.

# F. Indications For Use

The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.

# G. Substantial Equivalence

The components of the MosaicPlasty Comprehensive 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 Comprehensive
System Components | Substantially Equivalent Product |
| --- | --- | --- |
| Drill Template | Drill Guide
Arthroscopic Drill Guide | Drill Guide
(Synthes®) |
| Use with Template | Drill Plugs
Graft Template | Drill Sleeves
(Synthes) |
| Drilling in Bone | 2.4 mm Pilot Drill Bit
2.7 mm Arthr. Drill
Arthr. Reamer Drills
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
Transfer Plunger
Sculpture Stick | Tamps (Zimmer®) |
| Transferring bone graft to recipient site | Transfer Tubes
Arthr. Transfer Tubes
Chisel Collar | Bone Grafter
(Instrument Makar®) |

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| 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®) |
| For instrument access into joint | Metal Cannula | Metal Cannula (Smith & Nephew Endoscopy) |

Applicant Todd J. Brown
Date 12/17/96