PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

K071563 · Smith & Nephew, Inc. · HRS · Aug 8, 2007 · Orthopedic

Device Facts

• Record ID: K071563
• Device Name: PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Aug 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

PERI-LOC™ Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC™ contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula. PERI-LOC™ VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

Device Story

System consists of stainless steel contoured/straight locking bone plates and locking/non-locking bone screws; designed for orthopedic fracture fixation. Operates via screw-to-plate locking mechanism creating fixed-angle construct to maintain fracture reduction. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of bone segments to facilitate healing. Single-use device.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Stainless steel bone plates and screws; screw-to-plate locking mechanism for fixed-angle construct; various sizes of contoured and straight plates; single-use; non-sterile (implied by standard orthopedic practice).

Indications for Use

Indicated for adult and pediatric patients, including those with osteopenic bone, requiring fixation of partial articular fractures (AO/OTA Type B) of distal/proximal tibia, fibula, medial malleolus, distal ulna, olecranon, calcaneus, and metatarsals; also indicated for non-unions and osteotomies of these sites.

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

• PERI-LOC Periarticular Locked Plating System (K062216)
• PERI-LOC Periarticular Locked Plating System (K033669)
• PERI-LOC Periarticular Locked Plating System (K051735)
• Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) (K993106)
• Synthes One-Third Tubular DCL Plate (K011335)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness PERI-LOCTM Periarticular Locked Plating System VLP Locking Bone Plates and Locking/Non-Locking Bone Screws

| Submitted By: | Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date: | June 6, 2007 AUG - 8 2007 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager Tel: [phone] Fax: [phone] |
| Proprietary Name: | PERI-LOCTM Periarticular Locked Plating System - VLP Locking Bone Plates & Screws |
| Common Name: | Bone Plates and Bone Screws |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic bone fixation appliances and accessories - Class II |
| Device Product Code and Panel Code: | HRS, HWC / Orthopedics / 87 |

### Device Description:

PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ VLP locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

### Intended Use:

PERI-LOC™ Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC™ contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula. PERI-LOC™ VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

### Technological Characteristics:

Components comprising PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws 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.

- PERI-LOCTM Periarticular Locked Plating System K062216 .
- . PERI-LOCTM Periarticular Locked Plating System - K033669
- . PERI-LOCTM Periarticular Locked Plating System - K051735
- Smith & Nephew Bone Plate System (TC-100 Plating and Screw System) K993106 .
- Synthes One-Third Tubular DCL Plate K011335

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Image /page/1/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew, Inc. Orthopaedic Division % Mr. David Henley Regulatory Affairs Project Manager 1450 Brooks Road Memphis, Tennessee 38116

AUG - 8 2007

Re: K071563

> Trade/Device Name: PERI-LOC Periarticular Locked Plating System -VLP Locking Bone Plates and Locking/Non-locking Bone Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: June 6, 2007 Received: June 7, 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, 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

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### Page 2 – Mr. David Henley

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buehrig

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): _ 长೮71563 __________________________________________________________________________________________________________________________________________

Device Name: PERI-LOC° Periarticular Locked Plating System -VLP Locking Bone Plates and Locking/Non-locking Bone Screws

Indications for Use:

PERI-LOC* Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC° contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia, and for fracture fixation of the fibula. PERI-LOC* VLP One-Third Tubular Locking Plates are indicated for fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801.109)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Raubare brelund

Division of General, Restorative. and Neurological Devices

**510(k) Number** K071563