SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS

K042899 · Synthes (Usa) · HTO · Mar 16, 2005 · Orthopedic

Device Facts

• Record ID: K042899
• Device Name: SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
• Applicant: Synthes (Usa)
• Product Code: HTO · Orthopedic
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.

Device Story

Flexible reaming device for medullary canal preparation and autogenous bone/marrow harvesting. System comprises disposable tube assemblies, reamer heads, drive shaft seals, and reusable drive shafts. Operates via free-rotating reamer head attached to distal tube assembly; manifold ports enable simultaneous irrigation and aspiration during reaming. Irrigating fluid passes through drive shaft/reamer head cannula; debris/graft material aspirated through retainer/aspiration tube ports. Used by surgeons in clinical/OR settings to prepare canal for intramedullary implants or collect graft material. Benefits include expedited canal clearing and efficient harvesting of morselized bone graft for fusion or defect filling.

Technological Characteristics

Flexible reaming system; components include disposable tube assemblies, reamer heads, drive shaft seals, and reusable drive shafts. Features simultaneous irrigation and aspiration via manifold ports. Available in various lengths and diameters. Mechanical operation.

Indications for Use

Indicated for patients undergoing surgical procedures requiring bone graft or medullary canal preparation, including spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.

Regulatory Classification

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Predicate Devices

• Synthes RIA System
• Spine-Tech Bone Harvester

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary

Page _________ of ____ of __2_

| Sponsor: | SYNTHES (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System |
| Classification: | Class II, 21 CFR §888.4540, 888.1100<br>Orthopedic manual surgical instrument<br>Arthroscope and Accessories |
| Predicate Device: | Synthes RIA System<br>Spine-Tech Bone Harvester |
| Device Description: | Synthes RIA System is a flexible reaming device that consists of a<br>series of disposable tube assemblies, disposable reamer heads, tube<br>assemblies, drive shaft seals and reusable drive shafts. The device<br>is designed for expedited reaming of the medullary canal in<br>preparation for internal fixation. The RIA System is also designed<br>to harvest bone and bone marrow. The free-rotating reamer head<br>attaches to the distal end of the tube assembly. Ports in the<br>manifold of the tube assembly allow simultaneous irrigation and<br>aspiration through the tube assembly during the reaming process.<br>Irrigating fluid is passed through the cannula of the drive shaft and<br>reamer head and aspiration is drawn through ports of the retainer<br>and aspiration tube. The RIA System is available in various lengths<br>and diameters. |
| Intended Use: | Synthes RIA System is intended to clear the medullary canal of<br>bone marrow and debris and to effectively size the medullary canal<br>for the acceptance of an intramedullary implant or prosthesis; and<br>to harvest finely morselized autogenous bone and bone marrow for<br>any surgical procedure requiring bone graft to facilitate fusion<br>and/or fill bone defects. These procedures include spinal fusion,<br>joint arthrodesis, total joint replacement, fracture repair, nonunion,<br>maxillofacial reconstruction, and tumor removal. |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes RIA<br>System, is substantially equivalent* to other legally marketed<br>devices. |
| | * The term "substantially equivalent" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Food, Drug, and Cosmetic Act, as amended and as<br>applied under 21 CFR 807, Subpart E, under which a device can be<br>marketed without pre-market approval or reclassification. A |

{1}------------------------------------------------

K042899

etermination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matter. No statements
related to, or in support of substantial equivalence herein shall be
construed as an admission against interest under the US Patent
Laws or their application by the courts.

ತಿ ವೈ ಕ

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAR 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301

Re: K042899

Trade/Device Name: Synthes (USA) Reamer Irrigator Aspirator (RIA) System-Expanded Indications Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HTO and NBH Dated: March 4, 2005 Received: March 7, 2005

Dear Ms. Musgnung:

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 10 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Sheri L. Musgnung

This letter will allow you to begin marketing your device as described in your Sccion 510(k) I his letter will anow you to begin manketing your and equivalence of your device to a legally premarket notheation. The PDA midning of basification 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), please If you desire specific advice ion your as note the regulation entitled by the regulation entitled, contact the Office of Complaned at (210) = 16 = 1 = 1 807.97). You may obtain "Misbranding by relective to promance nobilities under the Act from the Division of Small other general Information on your responsion.com and its toll-free number (800) 638-204 or http:// [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Lester Morton

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

| 510(k) Number (if known): | K042899 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System -<br>Expanded Indications |
| Indications: | Synthes RIA System is intended to clear the medullary canal of<br>bone marrow and debris and to effectively size the medullary<br>canal for the acceptance of an intramedullary implant or<br>prosthesis; and to harvest finely morselized autogenous bone and<br>bone marrow for any surgical procedure requiring bone graft to<br>facilitate fusion and/or fill bone defects. These procedures<br>include spinal fusion, joint arthrodesis, total joint replacement,<br>fracture repair, nonunion, maxillofacial reconstruction, and tumor<br>removal. |

Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zack Attin

. Division Sign-Off) Division of Concell, Restorative and Neurological Devices

Number K042879