SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE

K010766 · Synthes (Usa) · KTT · Jun 12, 2001 · Orthopedic

Device Facts

• Record ID: K010766
• Device Name: SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jun 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

Device Story

Synthes Large Fragment LCP System - T Plate is a metallic buttress plate and screw system used for orthopedic fracture fixation. The device features a combination of round holes and locking screw holes. Locking screws create a fixed-angle construct with the plate, while standard screws facilitate bone reduction and compression. The system is used by orthopedic surgeons in a clinical or surgical setting to stabilize bone fractures, non-unions, and malunions, particularly in osteopenic bone. By providing structural support and rigid fixation, the device aids in bone healing and patient recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: 316L Stainless Steel and Titanium. Design: Buttress plate with combination round and locking screw holes. Compatibility: Accepts 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm/7.0 mm/7.3 mm cannulated, and 4.0 mm/5.0 mm locking screws. Principle: Fixed-angle locking construct and compression fixation.

Indications for Use

Indicated for patients with metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia, including those with osteopenic bone, non-unions, and malunions.

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 T Plates

Submission Summary (Full Text)

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KD10766

# 3. 510(k) Summary:

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| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Bonnie Smith |
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| Device Name: | Synthes (USA)<br>Large Fragment Locking Compression Plate (LCP) System - T Plate |
| Device Classification: | 21 CFR 888.3030: "Single/multiple component metallic bone<br>fixation appliance and accessories" and 888.3040: "Smooth or<br>threaded metallic bone fixation fastener". |
| Predicate Device: | Synthes T Plates |
| Description of Device: | Synthes Locking Compression Plate (LCP) System - T Plate is a<br>buttress plate and screw system. The primary feature of the plate is<br>round holes combined with locking screw holes. The locking<br>screws form a locked, fixed angle construct with the plate, while the<br>standard screws facilitate reduction and create compression between<br>the plate and bone. |
| | The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm<br>cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0<br>mm locking screws |
| Indications: | Intended to buttress metaphyseal fractures of the proximal humerus,<br>medial tibial plateau and distal tibia. Also for use in fixation of<br>osteopenic bone and fixation of non-unions and malunions. |
| Material: | 316L Stainless Steel<br>Titanium |

Premarket Notification 510(k) Synthes (USA) Large Fragment LCP System - T Plate CONFIDENTIAL

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

**JUN 1 2 2001**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K010766

Trade Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate

Regulation Number: 888.3030 Regulatory Class: Class II Product Code: KTT Dated: March 13, 2001 Received: March 14, 2001

Dear Ms. Smith:

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 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 proceed to the market.

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#### Page 2 - Ms. Bonnie J. Smith

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Bmutheuerston

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

Enclosures

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## 2. Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name:

Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate

K010766

Indications for Use:

Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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Premarket Notification 510(k) estorative Synthes (USA) Large Fragment LCP Sy CONFIDENTIAL

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510(k) Number K010766