PERI-LOC BONE PLATING AND SCREW SYSTEM

K083032 · Smith & Nephew, Inc. · HRS · Jan 7, 2009 · Orthopedic

Device Facts

• Record ID: K083032
• Device Name: PERI-LOC BONE PLATING AND SCREW SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The PERI-LOC™ Bone Plating and Screw 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. Components in the PERI-LOC™ Bone Plating and Screw System are for single use only.

Device Story

PERI-LOC™ Bone Plating and Screw System consists of titanium locking/non-locking bone plates, bone screws, washers, and screw adapters. Device functions as internal fixation hardware to stabilize fractures; screw-to-plate locking mechanism creates fixed-angle construct to maintain fracture reduction. Used by orthopedic surgeons in clinical/surgical settings. Titanium material provides biocompatible alternative to previously cleared stainless steel versions. System aids in bone healing by providing rigid fixation for various skeletal fractures.

Clinical Evidence

No clinical data provided; substantial equivalence based on design similarities and technological characteristics to predicate devices.

Technological Characteristics

Titanium bone plates and screws; locking and non-locking configurations; includes washers and screw adapters. Features screw-to-plate locking mechanism for fixed-angle constructs. Single-use, metallic bone fixation appliances.

Indications for Use

Indicated for adult and pediatric patients, including those with osteopenic bone, requiring fixation of pelvic, small, and long bone fractures (tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, clavicle).

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 Hexalobular Bone Screws (K082516)
• PERI-LOC™ Periarticular Locked Plating System Proximal Femur (K072818)
• PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates & Screws for the Upper Extremity (K061352)
• PERI-LOC™ Locking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735)
• Smith & Nephew Locking Bone Plate System (K033669)

Reference Devices

• Smith & Nephew Bone Plate System (K993106)
• Synthes Large Fragment DCL System (K000682)
• Synthes Small Fragment DCL System (K000684)
• Synthes LCP Proximal Humerus Plate (K011815)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness PERI-LOC™ Bone Plating and Screw System

Submitted By:

Date:

Contact Person:

Proprietary Name: Common Name:

Classification Name and Reference:

Smith & Nephew, Inc. JAN - 7 2009 1450 Brooks Road Memphis, TN 38116

October 9, 2008

David Henley, Regulatory Affairs Project Manager Tel: [phone] Fax: [phone]

PERI-LOC™ Bone Plating and Screw System Bone Plates and Bone Screws

21 CFR 888.3030. single/multiple component metallic bone fixation appliances and accessories - Class II 21 CFR 888.3040, smooth or threaded metallic bone fixation fastener - Class II

Device Product Code and Panel Code:

HRS, HWC, KTT, LXT / Orthopedics / 87

### Device Description:

The PERI-LOC™ Bone Plating and Screw System represents titanium versions of stainless steel PERI-LOC™ Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOC™ Bone Plating and Screw System devices feature various lengths of straight and contoured locking bone plates: locking and non-locking bone screws, washers, plus a screw adapter accessory. Bone plates in the PER/-LOC™ Bone Plating and Screw System feature a screw to-plate locking feature, which forms a locked, fixed-angle construct to aid in maintaining fracture reduction.

### Intended Use:

The PERI-LOC™ Bone Plating and Screw 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, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus and clavicle.

### Technological Characteristics:

The PERI-LOC™ Bone Plating and Screw System is similar to legally-marketed devices listed below in that they share similar indications for use 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 and overall indications for use.

- PERI-LOC™ Periarticular Locked Plating System Hexalobular Bone Screws (K082516) �
- PERI-LOCTM Periarticular Locked Plating System Proximal Femur (K072818) .
- PERI-LOC™ Periarticular Locked Plating System Locking Bone Plates & Screws for the Upper . Extremity (K061352)
- . PERI-LOC™ Locking Bone Plates and Locking Bone Screws for the Upper Extremity (K051735)
- Smith & Nephew Locking Bone Plate System (K033669) .
- Smith & Nephew Bone Plate System (K993106) .
- Synthes Large Fragment DCL System (K000682) .
- Synthes Small Fragment DCL System (K000684) .
- . Synthes LCP Proximal Humerus Plate (K011815)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stripes above it.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN - 7 2009

Re: K083032

Trade/Device Name: PERI-LOC™ Bone Plating and Screw System 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 9, 2008

Received: October 10, 2008

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 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

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## Page 2 - Mr. David Henley

marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

11 8

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark A. Milkein

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): K083032

PERI-LOC™ Bone Plating and Screw System Device Name:

Indications for Use:

The PERI-LOC™ Bone Plating and Screw 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.

Components in the PERI-LOC™ Bone Plating and Screw 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)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

***_*** and*_*, and I'm here to help. How can I assist you today?

(Division Division of General, Restorative. and Neurological Devices

**510(k) Number** K083032

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