SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

K111667 · Synthes (Usa) · JDS · Dec 5, 2011 · Orthopedic

Device Facts

• Record ID: K111667
• Device Name: SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
• Applicant: Synthes (Usa)
• Product Code: JDS · Orthopedic
• Decision Date: Dec 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions.

Device Story

Synthes Suprapatellar Insertion Instruments facilitate surgical approach for intramedullary nail insertion; components include aiming arms, protection sleeves, and trocars. Used in clinical settings by surgeons to assist in stabilizing tibial fractures. Instruments guide placement of Synthes Tibial Nail System EX implants. Benefit: enables suprapatellar surgical access for intramedullary nailing.

Clinical Evidence

No clinical data. Evidence based on bench testing, including in vitro studies under simulated use, biocompatibility testing, and dimensional/tolerance analyses.

Technological Characteristics

Metallic bone fixation accessories including aiming arms, protection sleeves, and trocars. Materials include standardized and non-standardized components (biocompatibility tested). Manual surgical instrumentation.

Indications for Use

Indicated for patients requiring stabilization of proximal/distal tibia fractures, tibial shaft fractures (open/closed), pre- and post-isthmic fractures, and tibial malunions/non-unions.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes (USA) Tibial Nail System EX (K040762)
• Smith & Nephew TriGen® Meta-Nail Retrograde Femoral and Tibial Nail System (K061019)

Submission Summary (Full Text)

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DEC - 5 2011

3.0 Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) Summary Synthes (USA) Sponsor: 1301 Goshen Parkway West Chester, PA 19380 [phone] June 10, 2011 Date: Thomas N. Shea Contact: Synthes (USA) 1301 Goshen Parkway West Chester, PA 19380 [phone] Device Name: Synthes Suprapatellar Insertion Instruments Classification: Class II, §888.3030 - Single / multiple component metallic bone fixation appliance and accessories. Product Code: JDS (Nail, Fixation, Bone) Predicate Synthes (USA) Tibial Nail System EX ( K040762 ). Devices: Smith & Nephew TriGen® Meta-Nail Retrograde Femoral and Tibial Nail System (K061019). The Synthes (USA) Suprapatellar Insertion Instruments consist of Device Description: aiming arms, protection sleeves, trocars, and accessory instruments which are intended to facilitate the surgical approach for the insertion of intramedullary nail implants of the Synthes Tibial Nail System EX. Indications for The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is Use: intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions. Information presented in this premarket notification supports that there Substantial are no effects of the described modification on the safety and Equivalence: effectiveness of the predicate Synthes Tibial Nail System EX (K040762).The modification does not affect the predicate system's indications for use, design of intramedullary implants, fundamental technology and or implant material composition. In vitro studies under simulated use, biocompatility testing of specific instrument components composed of non-standardized materials, as dimensional and tolerance based analyses were conducted and the results support the conlusion that there are no effects of the modification subject to this premarket notification on the safety and effectiveness of the Synthes Tibial Nail System EX.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

DEC - 5 2011

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

Synthes (USA) " % Mr. Christopher Hack 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K111667

Trade/Device Name: Synthes Suprapatellar Insertion Instruments Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDS Dated: October 26, 2011 Received: October 27, 2011

Dear Mr. Hack:

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. Christopher Hack

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,

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): | K111667 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Suprapatellar Insertion Instruments |
| Indications for Use: | The Synthes Suprapatellar Insertion Instruments are part of the Synthes Tibial Nail System EX. The Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non-unions. |

Prescription Use x (Per 21 CFR 801.109)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael Olsen to MMM

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

510(k) Number K111667