SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES

K050646 · Synthes (Usa) · HRS · Apr 26, 2005 · Orthopedic

Device Facts

• Record ID: K050646
• Device Name: SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Apr 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.

Device Story

Synthes LCP Medial Proximal Tibia Plates are metallic bone fixation devices contoured for the medial proximal tibia. Available in 3.5mm and 4.5mm versions, they feature a low-profile, limited-contact design with head holes for k-wires or sutures. Used by orthopedic surgeons in clinical settings to stabilize fractures, nonunions, malunions, or perform osteotomies. The plates provide structural support (buttressing) to the bone, facilitating healing and alignment. They are implanted via surgical procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium and stainless steel. Design: Contoured, low-profile, limited-contact plate. Features: 2.0mm head holes for k-wires or sutures. Available in 3.5mm and 4.5mm versions. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fixation of metaphyseal, split-type, or depression fractures of the medial tibia plateau; proximal quarter (lateral and medial) tibial fractures; segmental proximal tibia fractures; and, for the 4.5mm version, nonunions, malunions, and opening/closing wedge tibial osteotomies.

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) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates

Submission Summary (Full Text)

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K050646

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## APR 2 6 2005

## Summary of Safety and Effectiveness Information 3.0

Page 1 of 1

| SPONSOR: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19308 19380<br>[phone] |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| CLASSIFICATION: | Class II, §888.3030 - Plate, Fixation, Bone |
| PREDICATE DEVICE: | Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates |
| DEVICE DESCRIPTION: | The Synthes (USA) 3.5 / 4.5 mm LCP® Medial Proximal Tibia Plates are contoured to match the anatomy of the medial proximal tibia with a limited contact low profile design. The plates are designed for either the right or left medial proximal tibia in a variety of shaft lengths. These plates will be available in both 3.5 mm and 4.5 mm versions. The plate head exhibits 2.0 mm holes for preliminary fixation with k-wires, or meniscal repair with sutures. |
| INTENDED USE: | The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies. |
| SUBSTANTIAL EQUIVALENCE | Comparative information presented supports substantial equivalence. |
| MATERIAL: | Titanium and Stainless Steel |

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APR 2 € 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K050646

Trade/Device Name: Synthes (USA) 3.5/ 4.5mm LCP® Medial Proximal Tibia Plates Regulation Number: 21 CFR 888.3030

Regulation Name: Single/ multiple component metallic bone fixation appliances and accessories

Regulatory Class: II Product Code: HRS Dated: March 9, 2005 Received: March 14, 2005

Dear Ms. Anderson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your bected. Be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard) the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 2017).
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug de vices that have been require approval of a premarket approval application (PMA). and Costietle 710 (110.) that to novice, subject to the general controls provisions of the Act. The r ou may, dicierore, mainer of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it may of Subject to Saon addinensa Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of reacting your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not nean 1 Trase of advised that I Dr of issuates as our device complies with other requirements of the Act that IDA has made a determinations administered by other Federal agencies. You must of any I cacraf statutes and regarations and admited to: registration and listing (21 Comply with an the Act 8 requirements, not 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Kathy Anderson

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whil anow you to oegin maticoing your and of your device of your device to a legally prematics notification. "The PDT Imazing cification 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), please If you desire specific davice for your as 1240) 276-0120 . Also, please note the regulation entitled, Contact the Office of Compunance at (21 the Part 807.97). You may obtain Misoranding by relevelec to promance no ilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely yours,

VI Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Indications for Use Statement

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates Device Name:

Indications/Contraindications:

The Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Stylo Murdu

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number __