PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS

K072818 · Smith & Nephew, Inc. · HRS · Nov 19, 2007 · Orthopedic

Device Facts

• Record ID: K072818
• Device Name: PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS
• Applicant: Smith & Nephew, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

PERI-LOC™ Periarticular Locked Plating System consists of contoured locking bone plates, locking/non-locking bone screws, and cable accessories. Device functions as internal fixation for proximal femur fractures; screw-to-plate locking mechanism creates fixed-angle construct to maintain fracture reduction. Used by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of bone fragments to facilitate healing; benefits patients by restoring structural integrity to fractured or osteopenic bone. Components are single-use.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design and material similarities to legally marketed predicate devices.

Technological Characteristics

Metallic bone fixation system; materials include stainless steel and titanium. Features contoured locking plates and locking/non-locking screws. Employs screw-to-plate locking mechanism for fixed-angle construct. Single-use components.

Indications for Use

Indicated for adult patients, including those with osteopenic bone, for treatment of trochanteric region fractures (simple, reverse oblique, transverse, complex multifragmentary, medial cortex instability), proximal femur fractures with ipsilateral shaft fractures, pathological/metastatic proximal femur fractures, proximal femur osteotomies, nonunions, malunions, basi/transcervical femoral neck fractures, subcapital femoral neck fractures, and subtrochanteric femur fractures.

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

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

Submission Summary (Full Text)

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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 Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | NOV 19 2007<br>October 1, 2007 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager<br>Tel: [phone] Fax: [phone] |
| Proprietary Name: | PERI-LOC™ Periarticular Locked Plating System -<br>Proximal Femur Locking Bone Plates, Bone<br>Screws and Cable Accessories |
| Common Name: | Bone Plates and Bone Screws |
| Classification Name and Reference: | 21 CFR 888.3030, single/multiple component metallic<br>bone fixation appliances and accessories - Class II<br>21 CFR 888.3040, smooth or threaded metallic bone<br>fixation fastener - Class II |
| Device Product Code and Panel Code: | HRS, HWC / Orthopedics / 87 |

### 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.

### 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 .

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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 [phone]. 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 [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 yours,

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

Image /page/4/Picture/12 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 to represent data that can be read by a barcode scanner.