SELF RETAINING SOFT TISSUE RETRACTOR

K101609 · Koros USA, Inc. · LXH · Dec 9, 2010 · Orthopedic

Device Facts

• Record ID: K101609
• Device Name: SELF RETAINING SOFT TISSUE RETRACTOR
• Applicant: Koros USA, Inc.
• Product Code: LXH · Orthopedic
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4540
• Device Class: Class 1

Intended Use

Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .

Device Story

Self-Retaining Lumbar Retractor is a manual surgical instrument used to maintain surgical access to the spine during orthopedic procedures. The device is placed by a surgeon into a prepared incision to hold tissue apart, providing visualization and access to the surgical site. It is a mechanical device operated by a surgeon in an operating room setting. It does not utilize electronic inputs, software, or automated processing. The device benefits the patient by facilitating surgical access during spinal procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual orthopedic surgical instrument. Constructed of surgical-grade materials typical for retractors. Mechanical operation; no energy source, software, or connectivity. Sterilizable via standard hospital methods.

Indications for Use

Indicated for use in surgical procedures to provide surgical access to the spine. Intended for prescription use only.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Koros USA, Inc. % Mr. Tibor Koros 610 Flinn Avenue Moorpark, California 93021

Re: K101609

Trade/Device Name: Self-Retaining Lumbar Retractor Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: Class I Product Code: LXH Dated: November 15, 2010 Received: December 01, 2010

## Dear Mr. Koros:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

DEC - 9 2010

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Page 2 - Mr. Tibor Koros

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

AL. B. ntu
b.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE FORM

510 K Number: Device Name:

## K101609 Self-Retaining Lumbar Retractor

Page 1 of 1

INDICATION FOR USE:

DEC - 9 2010

Device is intended for use in surgical procedures to provide surgical access to the spine by
placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .

(Do not write below this line.)

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription use: X (Per 21 CFR 801.109)

Or

Over-The-Counter-Use: (Optional Format 1- )

Neil RP Order for men
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101609