ASCENSION ANKLE FUSION PLATE SYSTEM

K100176 · Ascension Orthopedics, Inc. · HRS · Jun 16, 2010 · Orthopedic

Device Facts

• Record ID: K100176
• Device Name: ASCENSION ANKLE FUSION PLATE SYSTEM
• Applicant: Ascension Orthopedics, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jun 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Arthrodesis of the ankle joint and distal tibia Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

Device Story

Ascension Ankle Fusion Plate System consists of anterior tibia-talus and lateral tibia-talus-calcaneus arthrodesis plates; plates contoured to peri-articular anatomy; feature tapered threaded holes accepting 4.5mm or 6.5mm compression or locking threaded screws. Used by orthopedic surgeons in clinical settings for bone fixation. Provides mechanical stabilization of bone segments to facilitate fusion or healing. Benefits patient by maintaining alignment and stability during bone recovery.

Clinical Evidence

No clinical data. Substantial equivalence supported by design and material comparison to predicate devices; no nonclinical testing required.

Technological Characteristics

Metallic bone fixation plates and screws. Materials: stainless steel or titanium. Features: contoured plates, tapered threaded holes for compression or locking screws (4.5mm or 6.5mm diameter).

Indications for Use

Indicated for patients requiring arthrodesis of the ankle joint and distal tibia, or treatment of fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

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 Ankle Arthrodesis Plates (K061940)
• Integra Advansys Lateral Tibio-Talar-Calcaneal Plate (K060473)
• Integra Tibiaxys (K073375)

Submission Summary (Full Text)

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# K100176

### 510(k) Summary of Safety and Effectiveness Ascension® Ankle Fusion Plate System

| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8700 Cameron Road<br>Austin, TX 78754-3832 | JUN 1 6 2010 |
|------------------------|--------------------------------------------------------------------------------------------------|--------------|
| 510(k) CONTACT: | Debbie Stearns<br>Phone: [phone] x1548 | |
| DATE SUMMARY PREPARED: | May 27, 2010 | |
| TRADE NAME: | Ascension® Ankle Fusion Plate System | |
| COMMON NAME: | Plate, Fixation, Bone | |
| CLASSIFICATION: | 21 CFR 888.3030 – Single/Multiple component<br>metallic bone fixation appliances and accessories | |
| PRODUCT CODE: | HRS | |
| PANEL: | Orthopedic | |

#### PREDICATE DEVICES:

K061940 - Synthes LCP Ankle Arthrodesis Plates K060473 - Integra Advansys Lateral Tibio-Talar-Calcaneal Plate K073375 - Integra Tibiaxys

#### DEVICE DESCRIPTION:

The Ascension® Ankle Fusion Plate System consists of two anterior tibia-talus and a lateral tibia-talus-calcaneus arthrodesis plates. The plates are contoured to the peri articular anatomy and have tapered threaded holes which accept compression or locking threaded screws with a maior thread diameter of 4.5 or 6.5mm. All plates and screws will be manufactured from stainless steel or titanium.

#### INTENDED USE:

The Ascension Ankle Fusion Plate System is intended for the following:

- > Arthrodesis of the ankle joint and distal tibia
- > Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

## SUMMARY OF TECHNOLOGIES:

The technological characteristics of the Ascension Ankle Fusion Plate System are the same, or similar to other leqally marketed predicate devices. The Synthes LCP ankle

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Arthrodesis (K061940), the Integra Advansys System (K060473), and Integra Tibiaxys have similar designs, same materials and indications.

### SUBSTANTIAL EQUIVALENCE:

Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials and indications.

Due to the similarity of materials and design to both pre-enactment and postenactment devices, it is believed that the Ankle Fusion Plate System does not raise any new safety or effectiveness issues and does not require any nonclinical testing. A comparison of dimensions/sizing addressing worst-case plates between the Ascension Ankle Fusion Plate System and the predicate devices was presented to support substantial equivalence.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

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

# JUN 1 6 2010

Ascension Orthopedics, Inc. % Ms. Debbie Stearns 8700 Cameron Road Austin, TX 78754-3832

Re: K100176

Trade/Device Name: Ascension Ankle Fusion Plate 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: June 2, 2010 Received: June 4, 2010

Dear Ms. Stearns:

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. Ilsting 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 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.

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Page 2 – Ms. Debbie Stearns

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.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Harbare Bnehm

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

Enclosure

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#### Indications for Use Statement 3

#### 6דוסטוק אַ 510(K) Number:

Device Name:

Ascension® Ankle Fusion Plate System

#### Indications for Use:

The Ascension Ankle Fusion Plate System is intended for the following:

- > Arthrodesis of the ankle joint and tibia
- > Fractures, osteotomies, fusions, and replantations of small bones in the foot and ankle.

Prescription Use × (Part 21 CFR 801Subpart B) OR

Over-The-Counter Use (Part 21 CFR 801Subpart C)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

Soutu for mxn
(Division Sign Off)

(Division Sign-( Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100176