SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

K001945 · Synthes (Usa) · HRS · Sep 22, 2000 · Orthopedic

Device Facts

• Record ID: K001945
• Device Name: SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Sep 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Device Story

Synthes Medial Distal Tibia Plates are orthopedic fixation devices designed for distal tibia fracture stabilization. Available in 3.5 mm and 4.5 mm sizes, these plates feature a pre-contoured, limited contact-dynamic compression plate (LC-DCP) design to match distal tibia anatomy. They are available in left and right versions and include a suture hole. The plates are compatible with 3.5 mm, 4.0 mm, 4.5 mm cortex screws, and 4.0 mm cancellous screws. Used by orthopedic surgeons in clinical or surgical settings, the plates provide mechanical stability to bone fragments, facilitating healing. The device is implanted during surgery to maintain alignment of fractured bone segments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel and CP titanium. Design: Limited contact-dynamic compression plate (LC-DCP). Form factor: Pre-contoured for distal tibia anatomy, available in 3.5 mm and 4.5 mm sizes. Fixation: Accepts 3.5 mm, 4.0 mm, 4.5 mm cortex screws and 4.0 mm cancellous screws. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for fixation of distal tibia fractures, including ankle, periarticular, intraarticular, distal tibia with shaft extension, malleolar, and distal fibular fractures in patients requiring surgical bone fixation.

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 Small T-Plate (pre-76)
• Synthes One-Third Tubular Plate (pre-76)
• Synthes 3.5 mm Cortex Screw (pre-76)

Submission Summary (Full Text)

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## SEP 22 2000

K001945

Attachment VII:

Summary of Safety and Effectiveness Information [510(k) Summary]

SUBMITTER

Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]

Contact: Angela Silvestri

DEVICE NAME:

COMMON OR USUAL NAME

DEVICE CLASSIFICATION:

PREDICATE DEVICE:

DESCRIPTION:

INTENDED USE:

MATERIAL:

Paoli, PA 19301
[phone]

**Contact:** Angela Silvestri

Synthes Medial Distal Tibia Plates

Appliance, Fixation, Nail/Blade/Plate Combination, Single Component; Screw, Fixation, Bone

Class II, 21 CFR 888.3030 and 888.3040

Synthes Small T-Plate (pre-76) Synthes One-Third Tubular Plate (pre-76) Synthes 3.5 mm Cortex Screw (pre-76)

Synthes Medial Distal Tibia Plates are available in two sizes: 3.5 mm and 4.5 mm. They are pre-contoured to fit the distal tibia anatomy. The plates feature a limited contact - dynamic compression plate (LC-DCP) design and are available in right and left versions. The end of the plate includes a hole for a suture, if necessary. The plates accept 3.5 mm, 4.0 mm, 4.5 mm cortex screws, and 4.0 mm cancellous screws.

Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

Stainless Steel and CP Titanium

Synthes Medial Distal Tibia Plates 510(k) Synthes (USA)

CONFIDENTIAL

000064

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Public Health Service

SEP 22 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Angela J. Silvestri Manager, Regulatory Affairs Synthes (USA) P.O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301

Re: K001945

Trade Name: Synthes (USA) Medial Distal Tibia Plates Regulatory Class: II Product Code: HRS Dated: June 23, 2000 Received: June 26, 2000

Dear Ms. Silvestri:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 control provisions of the Act. The general control 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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

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## Page 2 - Ms. Angela J. Silvestri

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific dayse for your astic devices), please contact the Office of Compliance at additionally 607.10 for in This anguestions on the promotion and advertising of your device, [phone]. Traditional [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsive at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner

GA 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

Enclosure

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## Indications for Use Statement 2.0

Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K001945

Synthes (USA) Medial Distal Tibia Plate Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

Dume R. Lochner

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K001945

Synthes Medial Distal Tibia Plates 510(k) Synthes (USA)

CONFIDENTIAL

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