ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM

• K Number: K072832
• Device Name: ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
• Manufacturer: DEPUY ORTHOPAEDICS, INC.
• Date Cleared: 2007-12-14 ( 72 days)
• Product Code: HRS
• Regulation Number: 888.3030
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K990120 , K983853 , K905048 , K882381
• Predicate For: K092812 , K111663

Intended Use

The Medial Locking Plate is indicated for:
-Pilon Fractures: distal tibial intra-articular fractures
-High medial malleolar fractures
-Low boot type rotational distal extra-articular shaft fractures

while the Anterolateral Locking Plate is indicated for:
-Distal intra-articular tibia fractures
-Proximal tibia fractures
-Proximal and distal humerus fractures

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Anterolateral and Medial Locking Plating System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI performance.

The key points from the document pertinent to its regulatory status are:

• Intended Use: The Medial Locking Plate is indicated for pilon fractures (distal tibial intra-articular), high medial malleolar fractures, and low boot type rotational distal extra-articular shaft fractures. The Anterolateral Locking Plate is indicated for distal intra-articular tibia fractures, proximal tibia fractures, and proximal and distal humerus fractures.
• Technological Characteristics: The technological characteristics are stated to be the "same as the predicate device including design and material."
• Substantial Equivalence: The submission asserts that the device is "substantially equivalent to the currently marketed DePuy devices" and that "No new issues of safety or efficacy have been raised."
• Predicate Devices: The document lists several DePuy devices as predicates: TiMax Medial Pilon Plate (K990120), TiMax Meta Plate (K983853), 3.5mm Cortical Bone Screws (K905048), and Cancellous Bone Screws (K882381).

In summary, there is no study described in this 510(k) summary that would provide acceptance criteria, reported device performance metrics, or the other detailed information requested about a study to prove a device meets acceptance criteria. This submission is based on demonstrating equivalence to existing devices, not on de novo performance testing against new criteria.

Summary

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K072832 (pg 1/1)

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Section 5 - 510(k) Summary

DEC 1 4 2007

Submitted by:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581Phone: [phone]Fax: [phone]
Contact Person:	Suzana Otaño, Sr. Regulatory Affairs Associate
Date Prepared:	October 2, 2007
Proprietary Name:	Anterolateral and Medial Locking Plating System
Common Name:	Plate, Fixation, Bone
ClassificationName:	Single/multiple component metallic bone fixation appliancesand accessories (21 CFR § 888.3030)
Predicate Devices:	DePuy	K990120	TiMax Medial Pilon Plate
	DePuy	K983853	TiMax Meta Plate
	DePuy	K905048	3.5mm Cortical BoneScrews
	DePuy	K882381	Cancellous Bone Screws
Intended Use:	The Medial Locking Plate is indicated for:-Pilon Fractures: distal tibial intra-articular fractures-High medial malleolar fractures-Low boot type rotational distal extra-articular shaft fractureswhile the Anterolateral Locking Plate is indicated for:-Distal intra-articular tibia fractures-Proximal tibia fractures-Proximal and distal humerus fractures
TechnologicalCharacteristics:	The technological characteristics of the Anterolateral andMedial Locking Plating System are the same as the predicatedevice including design and material.
Summary ofSubstantialEquivalence:	The Anterolateral and Medial Locking Plating System issubstantially equivalent to the currently marketed DePuydevices. No new issues of safety or efficacy have been raised.

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a triple-lined design resembling an abstract caduceus or a stylized representation of human figures, symbolizing health and well-being.

DEC 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy % Ms. Suzana Otaño Sr. Regulatory Affairs Associate 700 Orthopaedics Drive Warsaw, IN 46581

Re: K072832

Trade/Device Name: Anterolateral and Medial Locking Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: October 2, 2007 Received: October 3, 2007

Dear Ms. Otaño:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Suzana Otaño

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices.and Radiological Health

Enclosure

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K072832 (pg 1/1)

SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

Anterolateral and Medial Locking Device Name: Plating System

Indications For Use:

The Medial Locking Plate is indicated for: -Pilon Fractures: distal tibial intra-articular fractures -High medial malleolar fractures -Low boot type rotational distal extra-articular shaft fractures

while the Anterolateral Locking Plate is indicated for:

-Distal intra-articular tibia fractures

-Proximal tibia fractures

-Proximal and distal humerus fractures

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Mark A. Miller

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

510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.