INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY

K121482 · Theken Spine, LLC · HRX · Aug 28, 2012 · Orthopedic

Device Facts

• Record ID: K121482
• Device Name: INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY
• Applicant: Theken Spine, LLC
• Product Code: HRX · Orthopedic
• Decision Date: Aug 28, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery. The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

Device Story

Manual, hand-held surgical instrument set for endoscopic spinal decompression; includes guide wires, pituitaries, rongeurs, trephines, trocars/dilators, cannulas, reamers, dural elevators, nerve hooks, mallets, forceps, and chisels. Used by surgeons in clinical settings during endoscopic spinal procedures; requires use with an FDA-cleared endoscope (max length 254mm, working channel min 4.1mm). Instruments manipulate tissue or cut/bite bone during surgery. Benefits include facilitating minimally invasive spinal access and tissue management.

Clinical Evidence

No clinical or animal testing performed. Bench testing consisted of mechanical verification of individual instrument functions against design specifications. Cadaveric study performed by a surgeon skilled in percutaneous and endoscopic spinal procedures confirmed instruments performed as designed.

Technological Characteristics

Manual, hand-held surgical instruments. Materials: stainless steel, silicone, nitinol. Designed for use with external endoscopes. Sterilization method not specified. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients undergoing spinal surgical procedures including arthroplasty, nucleotomy, discectomy, and foraminotomy. Rongeurs are indicated for cutting or biting bone during spinal column 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

• maxMore Spinal Endoscopy System, Hoogland Spine Products (K090132)
• THESSYS Multiscope System, Joimax (K051827)

Submission Summary (Full Text)

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# 121482

#### 510(k) Summary (21 CFR Part 807.92)

Submitter's Name: Establishment Registration # Address:

Telephone Number: Fax Number: Contact Person: Email: Date Prepared:

Trade Name:

Common Name:

Device Classification:

Product Code:

Classification Panel:

Predicate Device:

Device Description:

Intended Use:

Material Composition:

Technological Characteristics:

Theken Spine, LLC 3008657535 1153 Medina Rd Medina, Ohio 44256 330-239-7709 330-239-4216 Dale Davison [e-mail] May 14, 2012

Instrument System for Endoscopic Spinal Surgery

Spinal Endoscopic System

Class II per 21 CFR 888.1100 - Arthroscope and accessories

HRX, HAE

Orthopedic

maxMore Spinal Endoscopy System, Hoogland Spine Products (K090132). THESSYS Multiscope System, Joimax (K051827)

The Integra Spine Instrument System for Endoscopic Spinal Surgery is an assembled, comprehensive set of instruments for use in endoscopic decompression techniques. The instrument set includes guide wires, pituitaries, ronguers, trephines, trocar / dilators, cannulas, reamers, dural elevator, nerve hook, mallet, forceps, chisels, and associated handles. The instrument set will be used with an FDA cleared endoscope with a length of no more than 254mm and working channel of at least 4.1mm.

The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

The Integra Spine Instrument System for Endoscopic Spinal Surgery is manufactured from stainless steel, silicone, and nitinol.

The technological characteristics of the Instrument System are equivalent to the predicate instrument system including use of similar designs, materials, procedure, sterilization methods, and operating principle.

Integra - 1153 Medina Rd., Medina, OH 44256 866-942-8698 toll free · 330-773-7697 fax · integralife.com AUG 28 2012

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Summary of test data:

Conclusion:

There were no clinical or animal tests performed for this submission. Mechanical testing consisted of verification testing of the individual instrument functions as there are no known performance standards. The instruments all performed as designed and met or exceeded all product specifications.

The Instrument System for Endoscopic Spinal Surgery was utilized in a cadaver setting by a surgeon skilled in percutaneous and endoscopic spinal procedures. All instruments performed as designed and met or exceeded all product specifications.

The specifications and intended use of the Instrument System for Endoscopic Spinal Surgery is the same as the predicate devices. There are no significant differences in design or manufacturing materials between this submission and the predicate device. This is based on the designs, the use of established known materials, feature comparisons, and indications for use. The instrument systems represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.

Integra - 1153 Medina Rd., Medina, OH 44256 866-942-8698 toll free - 330-773-7697 fax - integralife.com

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

AUG 2 8 2012

Theken Spine, LLC % Mr. Dale Davison Vice President, Engineering 1153 Medina Road Medina, Ohio 44256-0000

Re: K121482

Trade/Device Name: Instrument System for Endoscopic Spinal Surgery Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, HAE Dated: July 19, 2012 Received: July 20, 2012

Dear Mr. Davison

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 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

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#### Page 2- Mr. Dale Davison

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark Melkerson
Director
Division of Surgical, Orthopedic
MAY KAEPR
DEPFCレッ
Deuis

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

### 510(k) Number (if known): K121482

Device Name: Instrument System for Endoscopic Spinal Surgery

Indications For Use:

The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical The moralisms by tour roplasty, nucleotomy, discectomy, and foraminotomy. These manual proceal or truments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Neil R. Ogles fac mxm

Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K121482