SYNTHES LOCKING CALCANEAL PLATES

K991407 · Synthes (Usa) · LXT · Jun 11, 1999 · Orthopedic

Device Facts

• Record ID: K991407
• Device Name: SYNTHES LOCKING CALCANEAL PLATES
• Applicant: Synthes (Usa)
• Product Code: LXT · Orthopedic
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extraarticular, intra-articular, joint depression, tongue type and severely comminuted fractures.

Device Story

Synthes Locking Calcaneal Plates are orthopedic fixation devices designed for the lateral calcaneus. The plates feature 15 threaded screw holes accommodating 2.7 mm and 3.5 mm cortex screws and 3.0 mm locking screws. Used by orthopedic surgeons in clinical settings to stabilize complex calcaneal fractures and osteotomies. The device provides rigid internal fixation to support bone healing and restore structural integrity of the calcaneus. The plates are available in 69 mm and 76 mm lengths for right and left side applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 316L Stainless Steel, Ti-15Mo. Design: Locking plate with 15 threaded screw holes. Dimensions: 2.0 mm thickness, 69 mm and 76 mm lengths. Configuration: Lateral calcaneal application, left and right specific. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring fixation for fractures and osteotomies of the calcaneus, including extra-articular, intra-articular, joint depression, tongue type, and severely comminuted fractures.

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 Multiple Fragment Plate (preamendment)
• Synthes 3.0 mm PC-Fix™ System (K981372)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized image of a person. To the right of the word is a small circle with an R inside, indicating that the word is a registered trademark.

JUN 1 1 1999

K991407

Attachment VI:

SUBMITTER

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

- Synthes (USA) 1690 Russell Road Paoli, PA 19301 [phone]
Contact: Sheri L. Musgnung

Synthes Locking Calcaneal Plates

DEVICE NAME:

COMMON OR USUAL NAME

DEVICE CLASSIFICATION:

N.

Plate, fixation, bone

Class II, 21 CFR 888.3030

Synthes Multiple Fragment Plate (preamendment) PREDICATE DEVICE: Synthes 3.0 mm PC-Fix™ System, (K981372).

Synthes LCPs are designed to address complex fractures of the DESCRIPTION: calcaneus and are applied to the lateral side. The plate has 15 threaded screw holes, which accept 2.7 mm and 3.5 mm cortex screws, as well as 3.0 mm locking screws. The plates are 2.0 mm thick, 69 mm and 76 mm in length, and are available for right and left placements.

For fractures and osteotomies of the calcaneus, including, but INTENDED USE: not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.

- 316L Stainless Steel, Ti-15Mo MATERIAL:
Synthes (USA) Locking Calcaneal Plates CONFIDENTIAL

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or birds in flight, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 1999

Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, Pennsylvania 19301

K991407 Re : Synthes (USA) Locking Calcaneal Plates Trade Name: Regulatory Class: II Product Code: LXT Dated: April 21, 1999 Received: April 22, 1999

Dear Ms. Musgnung:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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## Page 2 - Ms. Sheri L. Musqnung

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 proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [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 Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten. Ph.D., M

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices.and Radiological Health

Enclosure

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510(k) Number (if known):

Synthes Locking Calcaneal Plates Device Name:

K991407

Indications For Use:

Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extraarticular, intra-articular, joint depression, tongue type and severely comminuted 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 _________________________________________________________________________________________________________________________________________________________

PCorella

(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices (مربع 0 رد 4 0 ر م ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 1 0 ر 510(k) Number _

Synthes (USA) Locking Calcaneal Plates CONFIDENTIAL

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