SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM

K000066 · Synthes (Usa) · HRS · Mar 15, 2000 · Orthopedic

Device Facts

• Record ID: K000066
• Device Name: SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Mar 15, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes LCP System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

Device Story

Synthes Locking Condylar Plate (LCP) System is a bone fixation device consisting of plates and screws. The system features a limited-contact profile, dynamic compression unit (DCU), and locking screw holes. Locking screws engage with the plate head and shaft to create a fixed-angle construct. The system accommodates various screw types, including 7.3 mm locking/conical screws, 5.0 mm locking/cannulated screws, and 4.5 mm cortex screws, along with a screw nut. Used by orthopedic surgeons in clinical settings to stabilize distal femur fractures, the device provides structural support to bone fragments, facilitating healing in both normal and osteopenic bone.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel plate and screw system. Features limited-contact profile, dynamic compression unit (DCU), and locking screw holes. Accommodates 7.3 mm locking/conical screws, 5.0 mm locking/cannulated screws, and 4.5 mm cortex screws. Provides fixed-angle construct via locking mechanism.

Indications for Use

Indicated for patients with multifragmentary distal femur fractures, including supracondylar, intra-articular, and extra-articular condylar fractures, as well as non-unions and malunions, occurring in normal or osteopenic bone.

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 Distal Femur Plate (DFP) System (K982222)

Submission Summary (Full Text)

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· Mar 1 5 2000

K00066

| Attachment VI: | Summary of Safety and Effectiveness Information<br>[510(k) Summary] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| | Contact: Sheri L. Musgnung |
| DEVICE NAME: | Synthes Locking Condylar Plate (LCP) System |
| COMMON OR USUAL<br>NAME | Appliance, Fixation, Nail/Blade/Plate Combination, Single<br>Component;<br>Screw, Fixation, Bone |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR 888.3030 and 888.3040 |
| PREDICATE DEVICE: | Synthes Distal Femur Plate (DFP) System, (K982222) |
| DESCRIPTION: | Synthes LCP System is a plate and screw system. The primary feature of<br>the plate and screw system is that the locking screws engage with the<br>head and shaft of the plate to form a locked, fixed angle construct. The<br>system features a limited-contact profile, dynamic compression unit<br>(DCU) and locking screw holes. The plate accepts 7.3 mm locking<br>screws, 7.3 mm conical screws, 5.0 mm locking screws, 5.0 mm<br>cannulated screws, and 4.5 mm cortex screws. A screw nut is also<br>utilized with this system. |
| INTENDED USE: | Synthes LCP System is intended for buttressing<br>multifragmentary distal femur fractures including:<br>supracondylar, intra-articular and extra-articular condylar<br>fractures, fractures in normal or osteopenic bone, and non-<br>unions and malunions. |
| MATERIAL: | Stainless Steel |

Synthes Locking Condylar Plate System 510(k) Synthes (USA)

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CONFIDENTIAL

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2000

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

Re: K000066

Trade Name: Synthes Locking Condylar Plate (LCP) System Regulatory Class: Class II Product Codes: HRS, HWC, HTY, and JDW Dated: January 7, 2000 Received: January 10, 2000

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 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). 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 requirements, 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 proceed to the market.

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Page 2 -- Ms. Sheri L. Musgnung

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 additionally 009110 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden

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 (USA) Locking Condylar Plate (LCP) System Device Name:

Indications For Use:

Synthes Locking Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

NPO for Faria

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K000066

CONFIDENTIAL