The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Device Description

The subject devices include PERI-LOC* Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws, which are line additions to and modifications to the PERI-LOC* Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking and non-locking bone screws made from stainless steel. PERI-LOC locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the PERI-LOC® Locking Bone Plates and Locking and Non-locking Bone Screws for the Upper Extremity. It describes a medical device and its intended use, and states that it is substantially equivalent to previously cleared predicate devices.

Based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting novel performance data.

Therefore, I cannot provide the requested information in the format requested. The document does not contain:

A table of acceptance criteria and the reported device performance: This information is absent.
Sample size used for the test set and the data provenance: This information is absent.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is absent.
Adjudication method for the test set: This information is absent.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is absent.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This information is absent.
The type of ground truth used: This information is absent.
The sample size for the training set: This information is absent.
How the ground truth for the training set was established: This information is absent.

The document primarily focuses on:

Device Description: The PERI-LOC® Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity are line additions and modifications to a previously cleared system. They are made from stainless steel and incorporate a screw-to-plate locking feature.
Intended Use: Fixation of pelvic, small, and long bone fractures in adult and pediatric patients, including those with osteopenic bone, across various anatomical sites.
Technological Characteristics: Similar to legally marketed devices, with identical indications for use (compared to K051735), identical material, and very similar technological characteristics.
Substantial Equivalence: Based on similarities with regard to overall indications for use, material composition, and technological design characteristics to predicate devices: Smith & Nephew Locked Plating System (K033669) and PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K051735).

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, subject to general controls provisions. This process for Class II medical devices like bone fixation appliances often relies on demonstrating equivalence to existing devices rather than requiring new clinical performance studies or specific acceptance criteria for novel performance metrics.

Summary

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510(k) Summary of Safety and Effectiveness

PERI-LOC' Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116JUN - 8 2006
Date:	May 12, 2006
Contact Person:	David Henley, Senior Regulatory Affairs SpecialistTel: (901) 399-6487 Fax: (901) 399-1557
Proprietary Name:	PERI-LOC® Periarticular Locked Plating System -Locking Bone Plates & Screws for the Upper Extremity
Common Name:	Bone Plates and Bone Screws
Classification Name and Reference:	21 CFR 888.3030, single/multiple component metallicbone fixation appliances and accessories - Class II21 CFR 888.3040, smooth or threaded metallic bonefixation fastener - Class II
Device Product Code and Panel Code:	HRS, HWC, KTT, LXT / Orthopedics / 87

Device Description:

Intended Use:

The PERI-LOC® Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Technological Characteristics:

Components comprising PERI-LOC° Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity are very similar to legally marketed devices listed below in that they share identical indications for use (compared to K051735), are manufactured from identical material, and incorporate very similar technological characteristics.

Substantial Equivalence Information:

When compared to the predicate devices listed below, substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.

Smith & Nephew Locked Plating System (PERI-LOC* Periarticular Locked Plating System) K033669 .
PERI-LOC Periarticular Locked Plating System for the Upper Extremity K051735 .

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN = 8 2006

Mr. David Henley Senior Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

/ Re:

K061352 Trade/Device Name: PERI-LOC Periarticular Locked Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Codes: HRS, HWC, KTT, LXT Dated: May 12, 2006 Received: May 15, 2006

Dear Mr. Henley:

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

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Page 2 - Mr. David Henley

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson, M.S.

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): _

PERI-LOC Periarticular Locked Plating System Device Name:

Indications for Use:

Components in the PERI-LOC* Periarticular Locked Plating System are for single use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

emol

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_ko61352

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.