THERMO-PLASTIC SHAVER BLADES

K963332 · Stryker Endoscopy · HRX · Oct 11, 1996 · Orthopedic

Device Facts

• Record ID: K963332
• Device Name: THERMO-PLASTIC SHAVER BLADES
• Applicant: Stryker Endoscopy
• Product Code: HRX · Orthopedic
• Decision Date: Oct 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications.

Device Story

Device consists of inner thermo-plastic and stainless steel tube rotating within outer stainless steel tube; powered by electrical motor in handpiece. Used in arthroscopic surgery for tissue resection; provides suction and cutting action. Operated by orthopedic surgeons in clinical/OR settings. Disposable, single-use design; provides precision control over location and extent of tissue resection. Benefits include effective tissue removal during arthroscopic procedures.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility per ISO 10993 and General Program Memorandum #G95-1. Packaging validated per ASTM standards.

Technological Characteristics

Materials: Thermo-plastic and stainless steel. Energy source: Electrical motor handpiece. Form factor: Rotating inner tube within outer tube. Sterilization: Gamma radiation (AAMI ST32, SAL 10^-6). Packaging standards: ASTM 4169, D999, D775, F88, D3078.

Indications for Use

Indicated for orthopedic arthroscopic applications requiring tissue resection.

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

• Linvatec, Merlin Polyblade shaver (K940515)

Submission Summary (Full Text)

{0}

stryker

2590 Walsh Avenue
Santa Clara, CA 95051

# K 963332

[phone]
[phone] Fax

OCT 11 1996

## Device Name:

| Current Classification Name | : | Arthroscope and accessories CFR 888.1100 Class II |
| --- | --- | --- |
| Expanded Classification Name | : | Surgical instruments motors/accessories |
| | | CFR 878.4820 Class I |
| Common and Usual Name | : | Surgical Shaver |
| Proprietary Name | : | Thermo-Plastic Shaver Blade |

## Device Sponsor

| : | Stryker Endoscopy |
| --- | --- |
| | 2590 Walsh Avenue |
| | Santa Clara, CA 95051 |
| | FDA Registration No. 2936485 |

## Regulatory Classification

: Class II

## SUMMARY OF SAFETY AND EFFECTIVENESS FOR THERMO-PLASTIC SHAVER BLADES

The Thermo-Plastic Shaver Blade is substantially equivalent to the Linvatec, Merlin Polyblade shaver manufactured by Linvatec per K940515.

The Thermo-Plastic Shaver Blades, consisting of an inner Thermo-Plastic and stainless steel tube which rotates inside of a stainless steel tube through the use of an electrical motor in a handpiece, is equivalent in intended use, safety and effectiveness to existing Thermo-Plastic shaver blades, used in similar applications, by Linvatec.

The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications. The material of construction, cutting action, availability of suction and tip configuration are equivalent to currently marketed products. As proven in arthroscopic applications, this design offers the required precision for controlling the location and extent of tissue resection.

The Thermo-Plastic Shaver Blades will use materials deemed to be biocompatible per ISO 10993 and the General Program Memorandum #G95-1. The disposable shaver blade is Gamma sterilized per AAMI ST32, SAL $10^{-6}$. Packaging is validated per ASTM standards 4169, D999, D775, F88, D3078.

The Stryker Thermo-Plastic Shaver Blades do not raise any new safety and efficacy concerns when compared to a similar device marketed by Linvatec. Therefore, the Stryker Thermo-Plastic Shaver Blades is substantially equivalent to the Linvatec, Merlin Polyblade shaver.

Eric Finley
Design Engineer

Enclosure