MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM

K013527 · Synthes (Usa) · HTO · Dec 21, 2001 · Orthopedic

Device Facts

• Record ID: K013527
• Device Name: MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HTO · Orthopedic
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

Synthes RIA System is a flexible surgical reaming device used to clear bone marrow and debris from the medullary canal and size it for implants. The system comprises disposable tube assemblies, disposable reamer heads, and reusable drive shafts. During surgery, the reamer head attaches to the distal end of the tube assembly. The device enables simultaneous irrigation and aspiration: irrigating fluid passes through the cannula of the drive shaft and reamer head, while debris is aspirated through ports in the retainer and aspiration tube. Used by surgeons in an operating room setting to expedite canal preparation for internal fixation. The device is available in diameters from 10 to 19 mm and lengths from 200 to 580 mm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible reaming system consisting of disposable tube assemblies, disposable reamer heads, and reusable drive shafts. Reaming diameters: 10-19 mm; effective lengths: 200-580 mm. Operates via mechanical rotation with integrated irrigation and aspiration channels. Manual surgical instrument.

Indications for Use

Indicated for patients requiring medullary canal preparation for intramedullary implant or prosthesis placement.

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 (USA) Reamer Irrigator Aspirator (RIA) System (K993335)

Submission Summary (Full Text)

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K013527

#### Summary of Safety and Effectiveness Information: 3.

DEC 21 2001

### 510(k) SUMMARY

| Submitter: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Bonnie Smith<br>[phone] |
| Name of the Device: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System |
| Classification: | Class II, 21 CFR 888.4540 and 888.1100 |
| Common or Usual Name: | Orthopedic manual surgical instrument; Arthroscope |
| Predicate (unmodified) Device: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System.<br>K993335 |
| Device Description: | Synthes RIA System is a flexible reaming device that<br>consists of a series of disposable tube assemblies,<br>disposable reamer heads and reusable drive shafts. The<br>device is designed for expedited reaming of the medullary<br>canal in preparation for internal fixation. The free-rotating<br>reamer head attaches to the distal end of the tube assembly.<br>Ports in the manifold of the tube assembly allow<br>simultaneous irrigation and aspiration through the tube<br>assembly during the reaming process. Irrigating fluid is<br>passed through the cannula of the drive shaft and reamer<br>head and aspiration is drawn through ports of the retainer<br>and aspiration tube. The RIA device is available in reaming<br>diameters ranging from 10 to 19 mm and effective reaming<br>lengths ranging from 200 to 580 mm. |
| Intended Use: | Synthes RIA System is intended to clear the medullary<br>canal of bone marrow and debris and to effectively size the<br>medullary canal for the acceptance of an intramedullary<br>implant or prosthesis. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, suggesting a sense of community and care.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 9 2002

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) P. O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301

Re: K013527

Trade Name: Synthes Reamer Irrigator Aspirator (RIA) System Regulation Number: 888.4540, 888.1100 Regulation Name: Orthopedic manual surgical instrument Arthroscope and Accessories

Regulatory Class: II Product Code: HTO, HRX Dated: November 29, 2001 Received: November 30, 2001

Dear Ms. Smith:

This letter corrects our substantially equivalent letter of December 21, 2001, regarding the regulation number and product code.

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). 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 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.

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#### Page 2 - Ms. Bonnie J. Smith

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.

This letter will allow you to continue 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 Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Muriam C. Provost

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

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2. Indications for Use

## Special 510(k) Device Modification

## INTENDED USE STATEMENT

510(k) Number (if known):

Device Name:

Indications

Synthes Reamer Irrigator Aspirator (RIA) System

K013527_______________________________________________________________________________________________________________________________________________________________________

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.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;"><span>OR</span><span style="margin-left: auto;">Over-the-Counter Use</span></div> |
| <center>(Division Sign-Off)</center> | |
| Division of General, Restorative<br>and Neurological Devices | |
| Special 510(k): Synthes RIA System<br>CONFIDENTIAL | |
| 510(k) Number | K013527 |
| | 000004 |