Who is the manufacturer of REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

Alliance Medical Corp. filed the 510(k) submission for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS (K012635).

What is the FDA product code for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

Stryker® Thermo-Plastic Shaver Blades (K963332); Stryker® Total Performance System Shaver Handpiece (K973195); Stryker®, Stryker Hip Arthroscopy Set (K982375).

Who can help prepare an FDA 510(k) submission like REPROCESSED STRYKER ARTHROSCOPIC SHAVERS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REPROCESSED STRYKER ARTHROSCOPIC SHAVERS

K012635 · Alliance Medical Corp. · HRX · Nov 7, 2001 · Orthopedic

Device Facts

Record ID	K012635
Device Name	REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
Applicant	Alliance Medical Corp.
Product Code	HRX · Orthopedic
Decision Date	Nov 7, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Device Story

Reprocessed arthroscopic shavers consist of a burr or blade at the end of a long rod rotating within a hollow stainless steel housing. The housing features a distal window allowing the burr to cut tissue while protecting adjacent structures. The device attaches to a motorized handpiece that drives the internal blade and provides suction to remove cut tissue from the surgical site. Used by surgeons in orthopedic, maxillofacial, hand, foot, and plastic surgeries to abrade, cut, and excise tissue and bone, or remove loose fragments. The device is reprocessed by Alliance Medical Corporation to restore functionality equivalent to the original manufacturer's device.

Clinical Evidence

Bench testing only. Testing included biocompatibility validation and functional performance testing to demonstrate that the reprocessed arthroscopic shavers perform as originally intended.

Technological Characteristics

Stainless steel housing with internal rotating burr or blade. Mechanical operation via motorized handpiece. Suction-assisted tissue removal. Design, materials, and dimensions are identical to predicate devices.

Indications for Use

Indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

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

Stryker® Thermo-Plastic Shaver Blades (K963332)
Stryker® Total Performance System Shaver Handpiece (K973195)
Stryker®, Stryker Hip Arthroscopy Set (K982375)

Related Devices

K012613 — REPROCSSED LINVATEC SHAVERS · Alliance Medical, Inc. · Nov 7, 2001
K012611 — REPROCESSED DYONICS ARTHROSCOPIC SHAVERS · Alliance Medical, Inc. · Nov 7, 2001
K012652 — REPROCESSED DYONICS ARTHROSCOPIC BURS · Alliance Medical Corp. · Nov 8, 2001
K012605 — REPROCESSED ATHROSCOPICS BURS · Alliance Medical Corp. · Nov 7, 2001
K012630 — REPROCESSED LINVATEC ARTHROSCOPIC BURS · Alliance Medical, Inc. · Nov 9, 2001

Submission Summary (Full Text)

{0}------------------------------------------------ NOV 0 7 2001 Image /page/0/Picture/1 description: The image shows the logo for Alliance Medical Corporation. The logo consists of three curved lines above the company name. The lines are thick and black, and they are arranged in a slightly arched shape. The text "ALLIANCE MEDICAL CORPORATION" is written in a simple, sans-serif font. K012635 ### PART B: 510(k) SUMMARY OF SAFETY ANQueenix, Arizon 8504 EFFECTIVENESS TEL 480.763.5300 Toll Free 880.763.5310 Toll Free 888.888.3433 Toll Free 888.888.3433 www.alliance-medical.com | Submitter: | Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044 | | | |----------------------|------------------------------------------------------------------------------------------|-------------------------------------|--| | Contact: | Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300 | | | | Date of preparation: | August 11, 2001 | | | | Name of device: | Trade/Proprietary Name: | Reprocessed Arthroscopic Shavers | | | | Common or Usual Name: | Arthroscopic Shaver | | | | Classification Name: | Arthroscope | | #### Reprocessed devices: | Manufacturer | Description | Model | Manufacturer | Description | Model | |--------------|-----------------------------|-------------|--------------|----------------------------|-------------| | Stryker | Jaguar Meniscus Cutter | 275-540 | Stryker | Whisker Cutter | 275-745 | | Stryker | Cougar End Cutter | 275-541 | Stryker | Scallop Cutter | 275-746 | | Stryker | Resector Cutter | 275-542 | Stryker | End Cutter | 275-747 | | Stryker | Aggressive Plus Cutter | 275-544-000 | Stryker | Slotted Whisker | 275-748-000 | | Stryker | Tomcat Cutter | 275-545-000 | Stryker | Full Radius | 275-752 | | Stryker | Angled Tomcat Cutter | 275-545-100 | Stryker | Aggressive Meniscus-Cutter | 275-754-000 | | Stryker | Cougar End Cutter | 275-551 | Stryker | Scalloped Cutter | 275-756-000 | | Stryker | Resector Cutter | 275-552 | Stryker | End Cutter | 275-757 | | Stryker | Resector Full Radius Cutter | 275-562-000 | Stryker | Slotted Whisker | 275-758 | | Stryker | Aggressive Plus | 275-564-000 | Stryker | Angled Aggressive Meniscus | 280-744 | | Stryker | Tomcat Cutter | 275-565-000 | Stryker | Angled Aggressive Meniscus | 280-754 | | Stryker | Full Radius Cutter | 275-732-000 | Stryker | Full Radius | 275-762 | | Stryker | Aggressive Meniscus Cutter | 275-734-000 | Stryker | Aggressive Meniscus Cutter | 275-764-000 | | Stryker | End Cutter | 275-737 | Stryker | Scallop Cutter | 275-766 | | Stryker | Full Radius | 275-742 | Stryker | Aggressive Meniscus Cutter | 277-744 | | Stryker | Aggressive Meniscus Cutter | 275-744-000 | Stryker | True End Cutter | 275-884 | ﻟﻤﺼﻨﻊ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻌﻠﻰ - 11:53 - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for Alliance. The logo consists of three curved lines stacked on top of each other, with the top line being the shortest and the bottom line being the longest. The lines are black and appear to be thick. Below the lines, the word "ALLIANCE" is written in capital letters. : # A L L I A N C E MEDICAL CORPORATION | Predicate device(s): | K963332 K973195 K982375 | Stryker® Thermo-Plastic Shaver Blades Stryker® Total Performance System Shaver Handpiece Stryker®, Stryker Hip Arthroscopy Set | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Device description: | Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a burr or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the burr to cut one structure while the adjacent one is still protected by the housing on the opposite side of the burr or blade. This system attaches to a motorized handpiece that drives the internal burr or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site. | | | Intended use: | Reprocessed Arthroscopic Shavers are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery. | | | Indications statement: | Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | | | Technological characteristics: | The design, materials, and intended use of the Reprocessed Arthroscopic Shavers are identical to the predicate devices. The mechanism of action of the Reprocessed Arthroscopic Shaver is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. | | | Performance data: | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers. Biocompatibility Validation of reprocessing Function Test(s) Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended. | | | Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed Arthroscopic Shaver) is safe, effective and substantially equivalent to the predicate devices as described herein. | | {2}------------------------------------------------ Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 0 7 2001 Mr. Don Selvey Vice President, Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044 Re: K012635 Trade/Device Name: Reprocessed Stryker® Arthroscopic Shavers Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: August 10, 2001 Received: August 13, 2001 Dear Mr. Selvey: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 - Mr. Don Selvey This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Susan Walker, up Celia M. Witten, Ph.D., M.D. J Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ NOV 0 7 2001 #### II. Indications for Use Statement ## 510(k) Number (if known): Device Name: Alliance Medical Corporation Reprocessed Arthroscopic Shavers Indications for Use: Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery. | | Manufacturer Description Description | Model | | . Manufacturer Description . Description . Model . | | |---------|--------------------------------------|-------------|---------|----------------------------------------------------|-------------| | Stryker | Jaguar Meniscus Cutter | 275-540 | Stryker | Whisker Cutter | 275-745 | | Stryker | Cougar End Cutter | 275-541 | Stryker | Scallop Cutter | 275-746 | | Stryker | Resector Cutter | 275-542 | Stryker | End Cutter | 275-747 | | Stryker | Aggressive Plus Cutter | 275-544-000 | Stryker | Slotted Whisker | 275-748-000 | | Stryker | Tomcat Cutter | 275-545-000 | Stryker | Full Radius | 275-752 | | Stryker | Angled Tomcat Cutter | 275-545-100 | Stryker | Aggressive Meniscus- Cutter | 275-754-000 | | Stryker | Cougar End Cutter | 275-551 | Stryker | Scalloped Cutter | 275-756-000 | | Stryker | Resector Cutter | 275-552 | Stryker | End Cutter | 275-757 | | Stryker | Resector Full Radius Cutter | 275-562-000 | Stryker | Slotted Whisker | 275-758 | | Stryker | Aggressive Plus | 275-564-000 | Stryker | Angled Aggressive Meniscus | 280-744 | | Stryker | Tomcat Cutter | 275-565-000 | Stryker | Angled Aggressive Meniscus | 280-754 | | Stryker | Full Radius Cutter | 275-732-000 | Stryker | Full Radius | 275-762 | | Stryker | Aggressive Meniscus Cutter | 275-734-000 | Stryker | Aggressive Meniscus Cutter | 275-764-000 | | Stryker | End Cutter | 275-737 | Stryker | Scallop Cutter | 275-766 | | Stryker | Full Radius | 275-742 | Stryker | Aggressive Meniscus Cutter | 277-744 | | Stryker | Aggressive Meniscus Cutter | 275-744-000 | Stryker | True End Cutter | 275-884 | Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (per 21 CFR 801.109) √ Susan Walker (Division Sign Division of General, estorative and Neurological De ices 112635 510(k) Number Over-the-Counter Use CONFIDENTIAL Alliance Medical Corporation Reprocessed Arthroscopic Shavers Traditional 510(k)