CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467

K101240 · DePuy Orthopaedics, Inc. · HRS · Jul 23, 2010 · Orthopedic

Device Facts

• Record ID: K101240
• Device Name: CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Device Story

System consists of plates and screws for bone fixation, fracture management, and reconstructive surgeries. Manufactured from titanium alloy and CoCr. Used by surgeons in clinical settings. Provides mechanical stabilization of bone segments to facilitate healing. Benefits patients by restoring structural integrity to compromised bone, particularly in osteopenic cases.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes construct static bending and galvanic corrosion testing to demonstrate mechanical and material equivalence.

Technological Characteristics

System components manufactured from titanium alloy and CoCr. Design features include locked plating mechanism for bone fixation. Characteristics are similar to predicate devices regarding material composition and geometry.

Indications for Use

Indicated for stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy), and non-unions of bones in hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula, and pelvis. Suitable for adults and pediatric patients (adolescents >12-21 years) provided implants do not cross open epiphyseal plates. Particularly indicated for osteopenic bone.

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

• LCL & Fusion Plating System (K091294)
• Mini Fragment Plating System (K061748)

Submission Summary (Full Text)

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## Section 5 — 510(k) Summary

| Submitted by: | DePuy Orthopaedics, Inc.<br>700 Orthopaedic Drive<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | JUL 2 3 2010 |
| Contact Person: | Suzana Otaño, Project Manager, Regulatory Affairs |
| Date Prepared: | April 29, 2010 |
| Proprietary Name: | DePuy ALPS Small Bone Locked Plating System |
| Common Name: | Plate, Fixation, Bone |
| Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories (21 CFR § 888.3030) |
| Predicate Devices: | The DePuy ALPS Small Bone Locked Plating System is substantially<br>equivalent to currently marketed devices including DePuy's LCL &<br>Fusion Plating System (K091294) and Mini Fragment Plating System<br>(K061748). |
| Device Description: | The DePuy ALPS Small Bone Locked Plating System consists of a<br>series of plates and screws manufactured from Titanium alloy and<br>CoCr used in bone fixation and the management of fractures and<br>reconstructive surgeries. |
| Indications for Use: | The DePuy ALPS Small Bone Locked Plating System is intended for<br>use in stabilization and fixation of fractures, revision procedures,<br>fusions, reconstructions (osteotomy) and non-unions of the bones of<br>the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle,<br>scapula and pelvis, particularly in osteopenic bone. The system can<br>be used in both adult and pediatric patients (adolescents [>12 - 21<br>years of age]), where the implant would not cross open epiphyseal<br>plates in skeletally immature patients. |
| Technological<br>Characteristics: | The technological characteristics of the DePuy ALPS Small Bone<br>Locked Plating System are similar to the predicate devices including<br>design and material. |
| Summary of<br>Substantial<br>Equivalence: | The DePuy ALPS Small Bone Locked Plating System is substantially<br>equivalent to currently marketed devices as demonstrated with pre-<br>clinical data. Testing included construct static bending and galvanic<br>corrosion testing, in addition to a comparison of indications for use,<br>materials, device geometry and design forming a basis for a<br>determination of substantial equivalence to legally marketed<br>predicate devices. |

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

### JUL 2 3 2010

DePuy Orthopaedics, Inc. % Ms. Suzana Otaño Project Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K101240

Trade/Device Name: DePuy ALPS Small Bone Locked Plating System Regulation Number: 21 CFP. 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 29, 2010 Received: May 4, 2010

Dear Ms. Otaño:

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.

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

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#### Page 2 - Ms. Suzana Otaño

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

Mark M. Millman

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

Enclosure

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SECTION 4 - INDICATIONS FOR USE STATEMENT

510(k) Number:

#### DePuy ALPS Small Bone Locked Device Name: Plating System

#### Indications For Use:

The DePuy ALPS Small Bone Locked Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quta for nxm
Division Sign off

(Division Sign Off) Division of Surgical Orthopedic, and Restorative Devices

510(k) Number K101240

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