AAP CANNULATED SCREW AND DARCO HEADED SCREW

K080101 · Aap Implantate AG · HWC · Mar 25, 2008 · Orthopedic

Device Facts

• Record ID: K080101
• Device Name: AAP CANNULATED SCREW AND DARCO HEADED SCREW
• Applicant: Aap Implantate AG
• Product Code: HWC · Orthopedic
• Decision Date: Mar 25, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The aup Cannulated Screw is intended for use over a quide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications. - Minimally invasive fracture / joint reconstructions . - . Additive osteosynthesis for complex joint fractures - . Multiple- fragment joint fractures - Femoral neck and femoral head fractures - . Femoral supracondylar fractures - Tibial plateau fractures . - Simple metaphyseal fractures . - . Simple epiphyseal fractures - o Fractures of the head of the humerus - o Fractures of the head of the tibia - o Cooper fractures of the tibia - o Fractures of the radius - Fractures of the wrist, ankle, elbow and shoulder - Scaphoid fractures and other fractures of the hand - Metatarsal fractures and other fractures of the foot . - Ligament fixation of the proximal humerus ● - . Fractures of the acetabulum - . Fractures of the dorsal pelvic ring - Condylar fractures - . Peadiatric epiphyseal and metaphyseal fractures - Ligament avulsion injuries (Apohysis) - Fractures of small joint bones ● - o Malleolar fractures - ্ Navicular fractures - Fractures of the calcaneus and talus - Arthrodesis of the ankle joint . - Avulsion fracture and metatarsl V . - . Fractures of the tarsal region

Device Story

Cannulated screws and washers used for bone fracture and fragment fixation; inserted over guide pin or wire. Manufactured from titanium alloy. Used in orthopedic surgical procedures for fracture stabilization, joint reconstruction, and arthrodesis. Provides mechanical fixation to facilitate bone healing. Operated by orthopedic surgeons in clinical/surgical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136 or ISO 5832-3). Cannulated design for use over guide pins/wires. Metallic bone fixation fastener. Class II device.

Indications for Use

Indicated for bone fracture and fragment fixation in patients requiring orthopedic reconstruction, including femoral, tibial, humeral, radial, pelvic, and small joint fractures, as well as ligament fixation and arthrodesis. Applicable to pediatric and adult populations.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• aap Small and Large Cannulated Screw System (K021233)
• aap Cannulated Screws and Washers (K990776)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "page 1 of 2" written in cursive, followed by the letters "aap" in a bold, sans-serif font. Below this, the text "K080101" is written in a handwritten style. The letters "aap" are large and prominent, with the "p" having a distinctive circular element.

MAR 2 5 2008

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions
of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this
information serves as a Summary of Safety and Effectiveness for the use of the aap
Cannulated Screws.

| Submitted By: | aap Implantate AG |
|------------------------------------|----------------------------------------------------------------------------------|
| Date: | January 8, 2008 |
| Contact Person: | Marc Seegers, Dipl.-Ing. |
| | Director QA/ RA |
| Proprietary Name: | aap Cannulated Screw |
| | DARCO® HEADED SCREW |
| Common Name: | Cannulated Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded<br>metallic bone fixation fastener - Class II |

#### Device Product Code and Panel Code:

Orthopedics/87/ HWC

#### DEVICE INFORMATION

# A. INTENDED USE

The aup Cannulated Screw is intended for use over a quide pin or wire for bone fracture fixation and bone fragment fixation. aap's washers may be used with the screws in certain applications.

- Minimally invasive fracture / joint reconstructions .
- . Additive osteosynthesis for complex joint fractures
- . Multiple- fragment joint fractures
- Femoral neck and femoral head fractures
- . Femoral supracondylar fractures
- Tibial plateau fractures .
- Simple metaphyseal fractures .
- . Simple epiphyseal fractures
- o Fractures of the head of the humerus
- o Fractures of the head of the tibia

Page 1 of 2

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- o Cooper fractures of the tibia
- o Fractures of the radius
- Fractures of the wrist, ankle, elbow and shoulder
- Scaphoid fractures and other fractures of the hand �
- Metatarsal fractures and other fractures of the foot .
- Ligament fixation of the proximal humerus ●
- . Fractures of the acetabulum
- . Fractures of the dorsal pelvic ring
- Condylar fractures
- . Peadiatric epiphyseal and metaphyseal fractures
- Ligament avulsion injuries (Apohysis)
- Fractures of small joint bones ●
- o Malleolar fractures
- ্ Navicular fractures
- Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint .
- Avulsion fracture and metatarsl V .
- . Fractures of the tarsal region

#### B. DEVICE DESCRIPTION

.

The aup Cannulated Screws and Washers are manufactured from Titanium Alloy conforming to ASTM F136 or ISO 5832-3. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.

## C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the aap Cannulated Screws are substantially equivalent to the previously cleared oup Small and Large Cannulated Screw System (K021233) and oap Cannulated Screws and Washers The safety and effectiveness of the aup Cannulated Screws is (990776). adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

aap Implantate AG % Mr. Marc Seegers, Dipl .- Ing Director, OA/RA Lorenzweg 5 12099 Berlin Germany

MAR 2 5 2008

K080101 Re:

> Trade/Device Name: aap Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 21, 2008 Received: February 25, 2008

Dear Mr. Seegers:

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 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. Marc Seegers, Dipl .- Ing

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

and the state of the state of the states of the states of the states

Sincerely yours,

Mark M Mulhern

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

and the comments of the country of the country

Enclosure

and the state of the same of the subject of

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# Indications for Use

510(k) Number (if known): K060101

Device Name: aap Cannulated Screws

## Indications for Use:

The agp Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. app's washers may be used with the screws in certain applications.

- Minimally invasive fracture / joint reconstructions
- Additive osteosynthesis for complex joint fractures
- Multiple- fragment joint fractures
- Femoral neck and femoral head fractures
- Femoral supracondylar fractures
- Tibial plateau fractures
- Simple metaphyseal fractures
- Simple epiphyseal fractures
- Fractures of the head of the humerus 0
- Fractures of the head of the tibia 0
- Cooper fractures of the tibia O
- Fractures of the radius 0
- Fractures of the wrist, ankle, elbow and shoulder
- Scaphoid fractures and other fractures of the hand
- Metatarsal fractures and other fractures of the foot
- Ligament fixation of the proximal humerus
- Fractures of the acetabulum
- Fractures of the dorsal pelvic ring
- Condylar fractures
- Peadiatric epiphyseal and metaphyseal fractures
- Ligament avulsion injuries (Apohysis)
- Fractures of small joint bones
- Malleolar fractures ಂ
- Navicular fractures 0
- Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint
- Avulsion fracture and metatarsl V
- Fractures of the tarsal region

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use *No*
(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)

1 of 1

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

**Neurological Devices**

510(k) Number K982191