STRYKER HIP ARTHOROSCOPY SET

K982375 · Stryker Endoscopy · HRX · Oct 2, 1998 · Orthopedic

Device Facts

• Record ID: K982375
• Device Name: STRYKER HIP ARTHOROSCOPY SET
• Applicant: Stryker Endoscopy
• Product Code: HRX · Orthopedic
• Decision Date: Oct 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

Device Story

Stryker Hip Arthroscopy Set comprises reusable extended-length rigid telescopic arthroscopes (30° and 70° oblique views) and manual surgical instruments; housed in hardened plastic sterilization trays. Used by orthopedic surgeons in clinical/OR settings to access, illuminate, and visualize deep hip joint confines. Instruments facilitate diagnostic evaluation, debridement of cartilaginous tissues, and removal of loose/foreign bodies. System functions in conjunction with Stryker disposable Hip Rotary Surgical Blades for tissue resection. Provides surgeons with direct visualization to guide surgical intervention, potentially improving outcomes for hip joint pathology.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Reusable surgical stainless steel instruments; extended-length rigid telescopic arthroscopes with 30° and 70° oblique view angles; hardened plastic sterilization tray. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring operative and diagnostic arthroscopic procedures of the hip joint, including evaluation, removal of loose bodies, and resection of soft, osseous, and cartilaginous tissues.

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

• Karl Storz arthroscopes (K963524)
• Smith & Nephew manual instruments (K971253)
• Karl Storz manual instruments (K963524)
• Arthrex manual instruments (K926212)

Submission Summary (Full Text)

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**stryker**
OCT 2 1998

2590 Walsh Avenue Santa Clara, CA 95051

## 982375

[phone] 408) 567-2505 Fax

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (REVISED)

Stryker Endos Joy

Applicant:

2590 Walsh Avenue Santa Clara, CA 95051 [phone]

Device Identification:

Common Name: Arthroscope and Accessories

Trade Name: Stryker Hip Arthroscopy Set

Contact:

Baltazar Acosta Hip Project Coordinator [phone]

Carlos Gonzalez Regulatory Affairs [phone]

Device Description: The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.

Indications: The Hip Arthroscopy Set is used for illumination and visualization of the deep confines of the hip joint. The Hip Arthroscopy Set is made size/length appropriate, and is indicated for use in approaching the hip joint for diagnostic evaluation and resection of various diseased soft tissues, debridement of cartilaginous tissues, and the removal of loose and foreign bodies in the hip joint.

Substantial Equivalence Statement: Stryker hip arthroscopes are claimed substantially equivalent (SE) to commercially available arthroscopes made by Karl Storz and cleared under K963524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex, cleared under K971253, K963524, and K926212 respectively.

Safety and Effectiveness: The Hip Arthroscopy Set is made size length appropriate, reflecting desirable characteristics as described by orthopedic surgeons now performing various hip arthroscopic procedures. The Stryker Hip Arthroscopy Set introduces no new risks to health as compared with existing commercially available devices.

Signed: Baltazar Acosta
Baltazar Acosta
Hip Project Coordinator

Signed: Carlos Gonzalez
Carlos Gonzalez
Regulatory Affairs

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 1998

Baltazar Acosta Hip Project Coordinator Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K982375 Trade Name: Stryker Hip Arthoroscopy Set Regulatory Class: II Product Code: HRX Dated: June 2, 1998 Received: July 7, 1998

## Dear Mr. Acosta:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Baltazar Acosta

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

C. Sadie McWitter, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number: K982375

Device Name: Stryker Hip Arthroscopy Set

Revised Indications For Use: (Revised)

The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="text-align:left;">✓</div> |
|----------------------|---------------------------------------|
| (Per 21 CFR 801 109) | |

OR

| Over the Counter Use | ________________ |
|----------------------|------------------|
|----------------------|------------------|

| | (Optional Format 1-2-96) |
|-----------------------------------------|--------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 1982375 |