AAP BONE PLATES AND SCREW IMPLANTS

K072411 · Aap Implantate AG · HRS · Mar 20, 2008 · Orthopedic

Device Facts

• Record ID: K072411
• Device Name: AAP BONE PLATES AND SCREW IMPLANTS
• Applicant: Aap Implantate AG
• Product Code: HRS · Orthopedic
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The aap bone plates and screws are provided non-sterile in a tray or separately packed. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Priciples of Fracture Management). All aap bone plates and screws are for single use only.

Device Story

aap Bone Plate and Screw Implants provide internal fixation for long and small bone fractures. System comprises various metallic plates (e.g., ACP, reconstruction, T-buttress, tubular, mini-fragment) and screws (cortical, cancellous, self-tapping). Devices are non-sterile; intended for single use by surgeons in clinical settings. Principle of operation involves mechanical stabilization of bone fragments following AO Foundation principles. Healthcare providers select appropriate plate/screw configuration based on fracture site and anatomy to facilitate bone healing. Benefits include structural support for fracture reduction and stabilization.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Materials: Commercial pure Titanium (ASTM F67/ISO 5832-2), 316L Stainless Steel (ASTM F139/ISO 5832-1), and Titanium Alloy (ASTM F136/ISO 5832-3). Form factor: Various plate geometries and screw diameters (1.5mm to 6.5mm). Sterilization: Non-sterile; end-user steam sterilization per AAMI/ANSI/ISO 11737 guidelines. Mechanical fixation principle.

Indications for Use

Indicated for treatment of fractures of the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges) in patients requiring internal bone fixation. Contraindicated for spinal fixation, patients with inflammation, sepsis, osteomyelitis, severe osteoporosis, metal sensitivity, or conditions compromising surgical success (e.g., tumors, vascular/neurological pathologies, joint destruction).

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

• Syntec-Taichung Bone Plate and Screw Implants (K983495)
• Synthes Sterile 2.7mm Reconstruction Plates (K974908)
• Synthes Bone Plates and Bone Screws for standard Osteosynthesis (Preamendment)
• Stryker Trauma Plating System (K000636)
• Stryker Plating System Basic Fragment Set (K012162)

Submission Summary (Full Text)

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K072411

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitters Name: | aap Implantate AG<br>Lorenzweg 5<br>12099 Berlin<br>Germany<br>Phone: [phone]<br>Fax: [phone] | MAR 20 2008 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Name: | Dipl.-Ing. Marc Seegers<br>Lorenzweg 5<br>12099 Berlin<br>Germany<br>Phone: [phone]<br>Fax: [phone]<br>email: [e-mail] | |
| Trade Name: | aap Bone Plate and Screw Implants | |
| Common/Usual Name: | Bone fixation plate and screw | |
| Classification Name: | Plate, Fixation, Bone Screw, Fixation, Bone | |
| Device Class: | Class II | |
| Product Code: | 87 HRS<br>87 HWC | |
| Classification: | CFR Chapter I, Title 21 § 888.3030<br>CFR Chapter I, Title 21 § 888.3040 | |
| Review Panel: | Orthopaedics | |

## Performance Standards:

- Devices are manufactured according to cGMP's, applicable ASTM require-. ments, and applicable harmonised standards ISO 13485:2003.
- . The aap Bone plates are manufactured from commercial pure Titanium (cpTi ASTM F67 or ISO 5832-2) and 316L Stainless Steel (ASTM F139 or ISO 5832-1 ).
- The agp Bone screws are manufactured from Titanium Alloy (ASTM F 136 or . ISO 5832-3) and (ASTM F 138 or ISO 5832-1).

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### Intended Use:

The aap bone plates and screws are provided non-sterile in a tray or separately packed. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Priciples of Fracture Management). All aap bone plates and screws are for single use only.

### Contraindications

Inflammation, sepsis and osteomyelitis are absolute contraindications.

All applications that are not defined by the indications and the specialist literature are contraindicated.

### All spinal fixation procedures.

In addition, surqical success can be adversely affected by:

- acute or chronic infections, local or systemic �
- vascular, muscular or neurological pathologies that compromise the � concerned extremity
- all concomitant pathologies that could affect the function of the implant.
- osteopathies with reduced bone substance such as severe osteoporosis ●
- . Any mental or neuromuscular disorder that could result in an unacceptable risk of failure at the time of fixation or complications in post-operative treatment.
- . Known or suspected sensitivity to metal
- � Corpulence: an overweight or corpulent patient can strain the implant to such a degree that stabilization or implant failure can occur.
- . Whenever the use of the implant comes into conflict with the anatomical structures of physiological status.

Other medical or surgical pre-conditions that could compromise the potentially beneficial procedure, such as:

- the presence of tumors �
- . congenital abnormalities
- . immunosuppressive pathologies
- increased sedimentation rates that cannot be explained by other pathologies
- . increased leukocyte (WBC) count
- . pronounced left shift in the differential leukocyte count.
- Untreated malfunction of the metabolism .
- Joint destruction caused by haemophilia, tabes or after infections �
- Instability of the joint ligaments .

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### Device Description: 得 - 在线 |

The aap bone plate and screw implants are used for internal fixation of long and small bones. The plates are manufactured from commercial pure Titanium or Stainless Steel and the screws are manufactured from Titanium alloy or Stainless Steel.

Plates (in brackets corresponding screw diameters):

- . 4.5 ACP Broad Plate (ø6,5mm/ ø4.5mm)
- 4.5 ACP Narrow Plate (ø6,5mm/ ø4,5mm) .
- Straight Reconstruction Plate 4.5 (ø4.5mm) .
- T-Plate 4.5 (ø6,5mm/ ø4,5mm) ●
- . T-Buttress Plate 4.5 (ø6,5mm/ ø4,5mm)
- L-Buttress Plate 4.5 (ø6,5mm/ ø4,5mm) �
- Spoon-Plate 4.5 (ø6,5mm/ ø4,5mm) .
- 3.5 ACP Straight Plate (ø4.0mm/ ø3.5mm) .
- 3.5 Straight Reconstruction Plate (ø3.5mm) ●
- 3.5 Cloverleaf Plate (ø4.0mm/ ø3.5mm) .
- . 3.5 T-Plate (ø4.0mm/ ø3.5mm)
- � 3.5 T-Plate olique angled (ø4.0mm/ ø3.5mm)
- 3.5 1/3 Tubular Plate (ø4.0mm/ ø3.5mm) .
- 2.7 Straight Plate (ø 2.7mm) .
- 2.7 Straight Reconstruction Plate (ø 2.7mm) .
- 2.7 Small T-Plate (ø 2.7mm) .
- . 2.7 1/4 Tubular Plate (ø 2.7mm)
- 2.0 Straight Mini-Fragment Plate (ø2.0mm) .
- Mini-Fragment T-Plate 2.0 (ø2.0mm) ●
- . Mini-Fragment with straight L-Shape 2.0 (ø2.0mm)
- . Mini-Fragment with oblique L-Shape 2.0 (ø2.0mm)

Screws:

ा में बाद में से मुक्त कर रहा है।
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- Cortical Screw (ø1.5mm) .
- Cortical Screw (ø2.0mm) and Cortical Screw selftapping (ø2.0mm) .
- Cortical Screw (ø2.7mm) and Cortical Screw selftapping (ø2.7mm) ●
- Cortical Screw (ø3.5mm) and Cortical Screw selftapping (ø3.5mm) .
- Cortical Screw (ø4.5mm) and Cortical Screw selftapping (ø4.5mm) .
- Cancellous Screw (ø4.0mm) and Cancellous Screw (ø4.0mm) with short . thread
- . Cancellous Screw (ø6.5mm) with full thread
- Cancellous Screw (ø6.5mm) with 16mm thread .
- Cancellous Screw (ø6.5mm) with 32mm thread .

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KC73911 + 4

### Predicate Devices for Substantial Equivalence:

- The aap bone plates and screws are similar in size, material and intended use to
- Syntec-Taichung Bone Plate and Screw Implants (K983495) �
- Synthes Sterile 2.7mm Reconstruction Plates (K974908) .
- Synthes Bone Plates and Bone Screws for standard Osteosynthesis (Prea-. mendment
- Stryker Trauma Plating System (K000636) .
- Stryker Plating System Basic Fragment Set (K012162) .

Comparision of the technological Characteristics of the device to the predicate legally marketed devices:

There are no significant differences between the aap Bone Plate and Screw Implants and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.

### Sterilisation Information:

؟ ﺍﻹ ﺍﻹﻃﺎﺭ

The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlined guidelines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 quidelines to achieve the acceptable Sterility Assurance Level (SAL).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the left. The eagle's body is formed by three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072411 Trade/Device Name: aap Bone Plates and Screw Implants Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: March 14, 2008 Received: March 17, 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.

MAR 2 0 2008

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

Sincerely yours.

Marti M. Millerson

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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# Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K072411

Device Name: aap Bone Plates and Screw Implants

Indications for Use:

The devices are intended to treat fractures of various bones, including the clavicle, scapyla, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All app bone plates and screws are for single use only and are not intended for any spinal fixation procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

(

AND/OR

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

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative,and Neurological Devices

510(k) Number_K072411