MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)

K091694 · Tag Medical Products · HWC · Jul 7, 2009 · Orthopedic

Device Facts

• Record ID: K091694
• Device Name: MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
• Applicant: Tag Medical Products
• Product Code: HWC · Orthopedic
• Decision Date: Jul 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

Device Story

Latarjet Cortical Screw Set consists of implantable fixation screws (36mm-48mm) and a threaded bushing; used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. Threaded bushing attaches to proximal end of screw to ensure stable positioning during procedure. Operated by orthopedic surgeons in clinical/surgical settings. Device provides mechanical fixation to assist in fracture management and reconstruction. Supplied non-sterile for single patient use.

Clinical Evidence

No clinical data; substantial equivalence based on design comparison and performance validation.

Technological Characteristics

Materials: Titanium alloy or Stainless Steel. Components: Fixation screws (36-48mm) and threaded bushing. Mechanical fixation device. Non-sterile, single-patient use.

Indications for Use

Indicated for orthopedic surgeons requiring bone fixation for fracture management and reconstructive surgeries.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Latariet Cortical Screw Set (K083096)

Submission Summary (Full Text)

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K091694 *'11

# 510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a) Submitter George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com T.A.G. Medical Products 1. (b) Manufacturer D. N. Ashrat Address: Kibbutz Gaaton 25130, Israel Mfg. Phone: Tel .: [phone] Contact Person: Dan Moor June 5, 2009 Date: Device & 2. Bone Fixation Screw, class II device (product code HWC). Classification Name: Latariet Cortical Screw Set The Latarjet Cortical Screw Set K083096 3. Predicate Device: The Latariet Cortical Screw Set consists of an implantable fixation screw 4. Description: which is used for fixation of bone grafts or bone fragments to cortical bone in shoulder surgeries. The fixation screws are offered in the following overall range of length: 36mm - 48mm. (features- other than the overall length- are identical on all). The set also includes a threaded bushing which attaches to the proximal end of the fixation screw. Its purpose is to position the screw firmly and safely during the fixation procedure. The bushing is provided in one size. The fixation screw and bushing are supplied in either in Titanium alloy or Stainless Steel. The Latarjet Cortical Screw Set is supplied nonsterile, for single patient use. Intended Use: The Latarjet Cortical Screw Set is intended to provide the orthopedic 5. surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries. 6. With respect to its indication for use, the Latarjet Cortical Screw Set is Comparison of substantially equivalent to its predicate device in that it intended for the Technological same clinical purpose. With respect to technology, the design is similar as Characteristics: confirmed by comparison, and the performance is the same as verified by validation. Based upon this, T.A.G. Medical Products believes that its device is safe and effective because it performs the same function in the same manner.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2009

i

T.A.G. Medical Products % Mr. George J. Hattub 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K091694

Trade/Device Name: Latarjet Cortical Screw Set Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 7, 2009 Received: June 10, 2009

Dear Mr. Hattub:

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 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 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.

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### Page 2 - Mr. George J. Hattub

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

Oinbare Ancus

Dot

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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## Indications for Use

# 510(k) Number (if known): 长09 \ 69 \

## Device Name: Latarjet Cortical Screw Set

Indications For Use: The Latarjet Cortical Screw Set is intended to provide the orthopedic surgeon a means of bone fixation and to assist in the management of fractures and reconstructive surgeries.

Prescription Use × (Part 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)

Onetta
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091694