SYNTHES LCP PEDIATRIC PLATE SYSTEMS

K112085 · Synthes (USA) Products, LLC · HRS · Nov 17, 2011 · Orthopedic

Device Facts

• Record ID: K112085
• Device Name: SYNTHES LCP PEDIATRIC PLATE SYSTEMS
• Applicant: Synthes (USA) Products, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Nov 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults. Specific indications for the 100°, 110°, 120°, 130°, 140°, 150° plates include: • Varus, valgus, rotational and/or shortening osteotomies • Femoral neck and/or pertrochanteric fractures • Proximal metaphyseal fractures • Diaphyseal fractures • Pathologic fractures • Prophylactic use for impending pathologic fractures Specific indications for the 90° plates include: • Varus, valgus, rotational and/or shortening osteotomies • Femoral neck and/or pertrochanteric fractures • Proximal and distal metaphyseal fractures • Diaphyseal fractures • Pathologic fractures • Prophylactic use for impending pathologic fractures

Device Story

System of metallic bone plates used for femoral fracture fixation and osteotomies in pediatric and small-statured adult populations. Plates feature Combi holes allowing for dynamic compression and locking functionality; compatible with existing cortical and locking screws. Designed for universal left/right application. Used by orthopedic surgeons in clinical/surgical settings to stabilize bone segments, facilitating healing and correcting deformities (varus, valgus, rotational, shortening). Benefits include structural support for bone healing and deformity correction.

Clinical Evidence

Bench testing only; no clinical data provided. Evidence consists of engineering strength analysis and fatigue testing.

Technological Characteristics

Metallic bone fixation plates; 2.7mm, 3.5mm, and 5.0mm sizes; 90° to 150° angles. Features Combi holes for dynamic compression and locking. Universal left/right design.

Indications for Use

Indicated for fixation of femoral fractures (including pathologic/impending pathologic) and osteotomies in infants, children, adolescents, and small-statured adults.

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 LCP Pediatric Plate System (K062872, K072095)
• Synthes Angled Blade Plates (K914546)
• Synthes 3.5mm Curved LCP Plates (K092609)

Submission Summary (Full Text)

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K//2085

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## Attachment B: Updated 510(k) Summary

| Date Prepared: November 16, 2011 | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes<br>Angela F. Lassandro<br>1301 Goshen Parkway<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes Pediatric LCP Plates |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallic bone<br>fixation appliances and accessories.<br>Product Code: HRS |
| Predicate Device: | Synthes LCP Pediatric Plate System (K062872, K072095)<br>Synthes Angled Blade Plates (Pre-amendment, K914546)<br>Synthes 3.5mm Curved LCP Plates (K092609) |
| Device Description: | The system is a collection of plates used to treat fractures and osteotomies of the<br>femur in infants, children, adolescents, and small statured adults. The complete<br>system includes the following:<br>• 3.5mm and 5.0 mm plates with a 90° angle<br>• 2.7mm, 3.5mm and 5.0 mm plates with a 100° angle<br>• 2.7mm, 3.5mm and 5.0 mm plates with a 110° angle<br>• 3.5mm and 5.0 mm plates with a 120° angle<br>• 2.7mm, 3.5mm and 5.0 mm plates with a 130° angle<br>• 3.5mm and 5.0 mm plates with a 140° angle<br>• 3.5mm and 5.0 mm plates with a 150° angle<br><br>The system accepts existing cortical and locking screws, and features allows for<br>both dynamic compression and locking through Combi holes. The plates are<br>universally designed for both left and right use. |
| Intended Use: | The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of<br>fractures (including pathologic and impending pathologic fractures) and<br>osteotomies of the femur in infants, children, adolescents and small statured<br>adults.<br><br>Specific indications for the 100°, 120°, 130°, 140°, 150° plates include:<br>• Varus, valgus, rotational and/or shortening osteotomies<br>• Femoral neck and/or pertrochanteric fractures<br>• Proximal metaphyseal fractures<br>• Diaphyseal fractures<br>• Pathologic fractures<br>• Prophylactic use for impending pathologic fractures |
| | Specific indications for the 90° plates include: |
| | • Varus, valgus, rotational and/or shortening osteotomies |
| | • Femoral neck and/or pertrochanteric fractures |
| | • Proximal and distal metaphyseal fractures |
| | • Diaphyseal fractures |
| | • Pathologic fractures |
| | • Prophylactic use for impending pathologic fractures |
| | • |
| Substantial<br>Equivalence: | Both the subject Synthes Pediatric LCP Plate System and predicate Synthes<br>LCP Pediatric Plate System, Angled Blade Plates, and 3.5mm Curved LCP<br>Plates have similar indications, design characteristics, materials, and<br>performance characteristics. Engineering strength analysis and fatigue testing<br>was completed for the plates included in the Synthes Pediatric LCP Plate<br>System. |

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112085

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 27, 2013

Synthes % Ms. Angela F. Lassandro Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K112085

Trade/Device Name: Synthes LCP Pediatric Plates 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 14, 2011 Received: October 18, 2011

Dear Ms. Lassandro:

This letter corrects our substantially equivalent letter of November 17, 2011.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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## Page 2 - Ms. Angela F. Lassandro

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note

the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The name is written in black ink. The letters "D", "K", and "A" are stylized with a pattern of lines and shapes.

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Revised Indications for Use Statement

510(k) Number (if known): K112085

Synthes Pediatric LCP Plates Device Name:

Indications for Use:

The Synthes (USA) Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.

Specific indications for the 100°, 110°, 120°, 130°, 140°, 150° plates include:

- · Varus, valgus, rotational and/or shortening osteotomies
- · Femoral neck and/or pertrochanteric fractures
- · Proximal metaphyseal fractures
- · Diaphyseal fractures
- · Pathologic fractures
- · Prophylactic use for impending pathologic fractures

Specific indications for the 90° plates include:

- · Varus, valgus, rotational and/or shortening osteotomies
- · Femoral neck and/or pertrochanteric fractures
- Proximal and distal metaphyseal fractures
- · Diaphyseal fractures
- · Pathologic fractures
- · Prophylactic use for impending pathologic fractures

AND/OR

x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use _ (Per 21 CFR 801.109)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Elizabeth L. Frank -S

Division of Orthopedic Devices