SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS

K072095 · Synthes (Usa) · JDS · Sep 27, 2007 · Orthopedic

Device Facts

• Record ID: K072095
• Device Name: SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS
• Applicant: Synthes (Usa)
• Product Code: JDS · Orthopedic
• Decision Date: Sep 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults. Specific indications include: • intertrochanteric rotational and/or varus osteotomies • femoral neck and/or pertrochanteric fractures • intertrochanteric valgus osteotomies and/or rotational osteotomies

Device Story

The Synthes Pediatric LCP Hip Plate System is a metallic bone fixation device used for proximal femur fractures and osteotomies. The system consists of plates available in 3.5 mm and 5.0 mm versions with various angles (100, 110, 120, 150 degrees). The plate head features three conical locking screw holes for fixed-angle constructs, while the shaft includes combination holes accepting either locking or cortex screws. The modification adds 3.5 mm cortex screws to the system. The device is used by surgeons in a clinical/OR setting to stabilize bone segments, facilitating healing through rigid fixation. It provides mechanical support to the femur, benefiting patients by maintaining alignment during the recovery process.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation plate system. Materials: 316L stainless steel. Components: Plates (3.5 mm and 5.0 mm) with conical locking screw holes and combination locked-compression screw holes. Fixed-angle construct capability. Available sterile and non-sterile.

Indications for Use

Indicated for fixation of proximal femur fractures and osteotomies in children, adolescents, and small-statured adults. Specific applications include intertrochanteric rotational, varus, or valgus osteotomies and femoral neck or pertrochanteric 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

• Synthes Pediatric LCP Hip Plate System
• Synthes Angled Blade Plates

Submission Summary (Full Text)

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K072095

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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized figure inside. A horizontal line is present beneath the word, adding emphasis to the brand name. The "®" symbol is located to the right of the word.

| 3.0 | 510(k) Summary | Page 1 of 1 |
|-----|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sponsor: | Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone]<br>SEP 27 2007 |
| | Contact: | Jill R. Sherman<br>Synthes (USA)<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>610-719-6538 |
| | Device Name: | Synthes (USA) Pediatric LCP Hip Plate System Modifications |
| | Classification: | 21 CFR Part 888.3030; Single/multiple component metallic bone<br>fixation appliances and accessories. |
| | Predicate Device: | Synthes Pediatric LCP Hip Plate System<br>Synthes Angled Blade Plates |
| | Device Description: | The Synthes (USA) Pediatric LCP Hip Plate System is available in<br>3.5 and 5.0 mm versions which include 100, 110, 120, and 150<br>degree angles. The plates are designed with three conical locking<br>screw holes located at the head in conjunction with 3 or 4<br>combination locked-compression screw holes at the shaft. The<br>fixed angle construct is created by means of three standard locking<br>screws inserted through the head of the plate. The shaft of the<br>plate accepts locking or cortex screws, depending on the nature of<br>the fracture or the quality of bone. |
| | | The Synthes (USA) Pediatric LCP Hip Plate System Modifications<br>to include 3.5 mm Cortex screws to be utilized with the plates. |
| | | The screws are manufactured from 316L stainless steel and<br>available both sterile and non-sterile. |
| | Intended Use: | The Synthes (USA) Pediatric LCP Hip Plate System is intended for<br>fixation of fractures and osteotomies of the proximal femur in<br>children, adolescents, and small statured adults.<br>Specific indications include:<br>• intertrochanteric rotational and/or varus osteotomies<br>• femoral neck and/or pertrochanteric fractures<br>• intertrochanteric valgus osteotomies and/or rotational<br>osteotomies |
| | Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2007

Synthes (USA) % Ms. Jill R. Sherman Regulatory Affairs / Compliance Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K072095

Trade/Device Name: Pediatric LCP Hip Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDS Dated: September 14, 2007 Received: September 17, 2007

Dear Ms. Sherman:

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

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## Page 2 - Ms. Jill R. Sherman

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 [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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark A. Mcllkeran

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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| 2.0 | Revised Indications for Use |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K072095 |
| Device Name: | Synthes (USA) Pediatric LCP Hip Plate System Modifications |
| Indications for Use: | The Synthes (USA) Pediatric LCP Hip Plate System is intended for fixation of fractures and osteotomies of the proximal femur in children, adolescents, and small statured adults.<br><br>Specific indications include: |
| | <ul><li>intertrochanteric rotational and/or varus osteotomies</li><li>femoral neck and/or pertrochanteric fractures</li><li>intertrochanteric valgus osteotomies and/or rotational osteotomies</li></ul> |

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milkern

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

072095