PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Device Description

PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various lengths of contoured locking bone plates and locking/non-locking bone screws made from stainless steel and titanium. PERI-LOC™ Proximal Femur 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 510(k) summary (K072818) describes the PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories, a medical device used for fracture fixation. The submission declares substantial equivalence to previously cleared devices.

Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance acceptance criteria in the typical format of a clinical or performance study report.

Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices. This means that the new device is deemed safe and effective because it is similar in design, materials, technological characteristics, and intended use to devices already on the market.

Therefore, many of the requested fields related to a performance study will be "Not Applicable" or "Not Provided" in this context.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Strength)	Reported Device Performance (Value/Outcome)
Substantial Equivalence to Predicate Devices	Device is substantially equivalent to legally marketed predicate devices in design features, overall indications for use, and material composition.
Material Composition	Similar to predicate devices (Stainless Steel and Titanium).
Technological Characteristics	Similar to predicate devices (e.g., screw-to-plate locking feature forms a locked, fixed angle construct).
Indications for Use	Similar to predicate devices (e.g., fractures of the trochanteric region, proximal femur fractures, pathological fractures, osteotomies, nonunions, malunions, femoral neck fractures, subtrochanteric femur fractures).

Explanation: The "acceptance criteria" here is primarily the demonstration of substantial equivalence. The "device performance" is implicitly met by virtue of being equivalent to devices already proven safe and effective. No specific numerical performance metrics are provided for the new device as a standalone entity in this submission.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable / Not provided. This submission relies on substantial equivalence rather than a new performance study with a specific test set of data.
Data Provenance: Not applicable / Not provided. The evaluation is based on a comparison to existing predicate devices, not on new data collected for this specific device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable / Not provided. No specific "ground truth" for a test set was established by experts for this 510(k) as part of a performance study.
Qualifications of Experts: Not applicable / Not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable / Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a submission for a bone plating system, not an imaging or diagnostic device requiring human reader interpretation in an MRMC study.
Effect Size of Human Readers with vs. without AI: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study Done: No. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable / Not provided in the context of a dedicated performance study for this device. The "ground truth" for the substantial equivalence claim rests on the established safety and effectiveness of the predicate devices in clinical use.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable / Not provided. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable / Not provided.

Summary

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K072818
ess

510(k) Summary of Safety and Effective PERI-LOC™ Periarticular Locked Plating System Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories

Submitted By:	Smith & Nephew, Inc., Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	NOV 19 2007October 1, 2007
Contact Person:	David Henley, Regulatory Affairs Project ManagerTel: (901) 399-6487 Fax: (901) 399-1557
Proprietary Name:	PERI-LOC™ Periarticular Locked Plating System -Proximal Femur Locking Bone Plates, BoneScrews and Cable Accessories
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 / Orthopedics / 87

Device Description:

Intended Use:

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates and Bone Screws can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Technological Characteristics:

Components comprising PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics.

Substantial Equivalence Information:

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

Smith & Nephew Bone Plate System (TC-100 Plating System) Blade Plates K993289 .
. PERI-LOCTM Periarticular Locked Plating System - K033669
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736 .
Synthes (USA) LCP Proximal Femur Plate and Screws K030858 .

Image /page/0/Picture/15 description: The image shows a series of vertical black and white bars, resembling a barcode. The bars vary in width and spacing, creating a distinct pattern. The image is high contrast, with sharp transitions between the black and white areas. The barcode appears to be partially damaged or distorted.

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Premarket Notification Indications for Use Statement

510(k) Number (if known): K072818_

PERI-LOC™ Periarticular Locked Plating System -Device Name: Proximal Femur Bone Plates, Bone Screws and Cable Accessories

Indications for Use:

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone: fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Bone Plates and Bone Screws are for single use only.

X X Over-the-Counter Use Prescription Use (Part 21 CFR 801.109) (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)

Image /page/1/Picture/9 description: The image shows a barcode. The barcode consists of a series of vertical black bars of varying widths, separated by white spaces. The bars and spaces are arranged in a specific pattern that represents data, which can be read by a barcode scanner. The barcode appears to be a standard linear barcode.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NDV 1 9 2007

Smith & Nephew, Inc., Orthopaedic Division % Mr. David Henley 1450 Brooks Road Memphis, TN 38116

Re: K072818

Trade/Device Name: PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: October 1, 2007 Received: October 2, 2007

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. Iisting 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 mav 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 – Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and in your he FDA finding of substantial equivalence of your device to a legally promative noticated with 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, presse contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ararbare, Buchu
ra

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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Premarket Notification Indications for Use Statement

510(k) Number (if known): K072818____________________________________________________________________________________________________________________________________________

PERI-LOC™ Periarticular Locked Plating System -Device Name: Proximal Femur Bone Plates, Bone Screws and Cable Accessories

Indications for Use:

PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multifragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.

Components in the PERI-LOC™ Periarticular Locked Plating System - Proximal Femur Bone Plates and Bone Screws are for single use only.

Over-the-Counter Use AND/OR X Prescription Use (Part 21 CFR 801.109) (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)

Chubermueno

Division of General, Restorative, and Neurological Devices

510(k) Number K072818

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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.