The aap Cannulated Screws are intended for use over a guide 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 reconstruction of fractures and joints
adjuvant for osteosynthesis in complex joint fractures
multifragment joint fractures
fractures of the femoral head and neck
supracondylar femoral fractures
tibial plateau fractures
simple metaphyseal fractures
simple epiphyseal fractures such as:
fractures of the humeral head
fractures of the tibial plateau
pilon fractures
fractures of the radius
fractures of the wrist, ankle, elbow, and shoulder
scaphoid fracture and other fractures of the hand
metatarsal fractures and other fractures of the foot
ligament fixation at the proximal humerus
acetabular fractures
fractures of the posterior pelvic ring
condylar fractures
epiphyseal and metaphyseal fractures in children
ligament avulsion injuries
fractures of small joints, such as:
ankle fractures
navicular fractures
calcaneal and talar fractures
arthrodesis of the ankle
avulsion fractures and fractures of metatarsal V
tarsal fractures

Device Description

The app Cannulated Screws are manufactured from Titanium Alloy conforming to ASTM F136 or ISO 5832-3 and Stainless Steel conforming to ASTM F138 or ISO 5832-1. The Screws are offered in varying overall lengths and thread lengths to accommodate variability among patients.

AI/ML Overview

This 510(k) premarket notification for the aap Cannulated Screws 2.7-7.5 is for a line extension of previously cleared devices (K021233 and K080101). As such, it does not involve the type of clinical study typically associated with an AI/ML medical device. Instead, the "study" for this device is a demonstration of substantial equivalence through mechanical testing and comparison to predicate devices.

Here's the breakdown based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for this traditional medical device submission revolve around demonstrating substantial equivalence to existing, legally marketed predicate devices in terms of material, design, mechanical performance, and indications for use.

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Conformity to predicate device materials.	The aap Cannulated Screws are manufactured from Titanium Alloy conforming to ASTM F136 or ISO 5832-3 and Stainless Steel conforming to ASTM F138 or ISO 5832-1, which aligns with materials typically used in predicate bone fixation devices. The submission states, "The design features, material, and indications for use of the aap Cannulated Screws 2.7-7.5 are substantially equivalent to the previously cleared aap Small and Large Cannulated Screw System (K021233) and agp Cannulated Screws (K080101)."
Design Equivalence: Similar design features to predicate devices despite new lengths/thread lengths.	The submission is for a "line extension" involving "new overall lengths and thread lengths" for previously cleared screw systems. This indicates the fundamental design principles remain consistent with the predicate devices.
Mechanical Performance Equivalence: Performance comparable to predicate devices and relevant standards.	"Mechanical tests per ASTM F543 were conducted for those screws for which no test reports have been provided with the predicate device submissions K021233 and K080101 to verify the safety and effectiveness of the additional screws." This demonstrates that the new sizes meet established mechanical performance standards for bone fixation fasteners.
Indications for Use Equivalence: Similar intended uses as predicate devices.	The Indications for Use section lists a broad range of bone fracture and fragment fixations, consistent with the applications for cannulated screws and mirroring the predicate devices. The submission explicitly states, "The design features, material, and indications for use of the aap Cannulated Screws 2.7-7.5 are substantially equivalent to the previously cleared aap Small and Large Cannulated Screw System (K021233) and agp Cannulated Screws (K080101)."

2. Sample Size for Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of an AI/ML device. For this submission, "test set" refers to the specific new screw sizes and materials that underwent mechanical testing. The document does not specify the exact number of new screws or configurations tested, but it refers to "those screws for which no test reports have been provided with the predicate device submissions."
Data Provenance: The mechanical testing data would have been generated in a laboratory setting, likely in Germany (based on the applicant's location). This would be prospective testing conducted specifically for this submission. The "data" also includes the specifications and performance of the predicate devices.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. For this type of device, ground truth is established through material standards (ASTM, ISO), established design principles for orthopaedic implants, and mechanical testing protocols. There isn't a need for expert consensus on a 'ground truth' in the same way as evaluating diagnostic image interpretation.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. The "adjudication" is achieved through compliance with established mechanical testing standards (ASTM F543) and comparison to the performance of predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is not an AI/ML device, so an MRMC comparative effectiveness study is not relevant or performed.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance Study: No. This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of AI is not applicable. The equivalent here would be the physical device's mechanical performance, which was evaluated through testing.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this device is based on engineering standards, material specifications, and the established safety and effectiveness of predicate devices. Specifically:
- Material Standards: ASTM F136, ISO 5832-3 (Titanium Alloy), ASTM F138, ISO 5832-1 (Stainless Steel).
- Mechanical Testing Standards: ASTM F543.
- Predicate Device Performance: The previously cleared aap Small and Large Cannulated Screw System (K021233) and aap Cannulated Screws (K080101) serve as the established benchmark for safety and effectiveness.

8. Sample Size for Training Set

Training Set Sample Size: Not applicable. This is not an AI/ML device, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

Summary

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K111316

JUL 2 0 2011

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 2.7-7.5.

Submitted By:	aap Implantate AGLorenzweg 512099 BerlinGermanyPhone: +49 30 750 19 0Fax: +49 30 750 19 111
Date:	May 6, 2011
Contact Person:	Marc Seegers, Dipl.-Ing.Director QA/ RALorenzweg 512099 BerlinGermanyPhone: +49 30 750 19 192Fax: +49 30 750 19 111
Proprietary Name:	aap Cannulated Screw
Common Name:	Cannulated Screw
Classification Name and Reference:	21 CFR 888.3040 Smooth or threadedmetallic bone fixation fastener - Class II
Device Product Code and Panel Code:	Orthopedics/87/HWC

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Image /page/1/Picture/0 description: The image contains a sequence of handwritten characters. The characters appear to be "K111316", with the "K" being a stylized version. The numbers are written in a simple, clear style, and the overall impression is that of a quickly written note or label.

DEVICE INFORMATION

A INTENDED USE

The aap Cannulated Screw is intended for use over a guide 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 reconstruction of fractures and joints
. adjuvant for osteosynthesis in complex joint fractures
� multifragment joint fractures
. fractures of the femoral head and neck
. supracondylar femoral fractures
. tibial plateau fractures
. simple metaphyseal fractures
simple epiphyseal fractures such as: �
- o fractures of the humeral head
- o fractures of the tibial plateau
- o pilon fractures
- o fractures of the radius
fractures of the wrist, ankle, elbow, and shoulder
scaphoid fracture and other fractures of the hand ●
. metatarsal fractures and other fractures of the foot
ligament fixation at the proximal humerus .
. acetabular fractures
fractures of the posterior pelvic ring ●
condylar fractures .
epiphyseal and metaphyseal fractures in children ●
ligament avulsion injuries .
. fractures of small joints, such as:
- o ankle fractures
- o navicular fractures
. calcaneal and talar fractures
. arthrodesis of the ankle
avulsion fractures and fractures of metatarsal V �
. tarsal fractures

DEVICE DESCRIPTION B

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111316

C DESCRIPTION OF DEVICE MODIFICATION

This special 510(k) submission is intended to introduce a line extension to the predicate aap Small and Large Cannulated Screw System (K021233) and aap Cannulated Screws (K080101), which consists of the addition of new overall lengths and thread lengths both for titanium alloy and stainless steel screws.

D SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the aap Cannulated Screws 2.7-7.5 are substantially equivalent to the previously cleared aap Small and Large Cannulated Screw System (K021233) and agp Cannulated Screws (K080101). The safety and effectiveness of the agp Cannulated Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

E SUMMARY OF VERIFICATION ACTIVITIES

Documentation is provided which demonstrates that the additional screws to be substantially equivalent to the predicate devices in terms of material, design, mechanical performance and indications for use. Mechanical tests per ASTM F543 were conducted for those screws for which no test reports have been provided with the predicate device submissions K021233 and K080101 to verify the safety and effectiveness of the additional screws.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.

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

aap Implantate AG % Marc Seegers, Dipl .- Ing. Director, Quality Assurance/Regulatory Affairs Lorenzweg 5 Berlin, Germany 12099

JUL 20 2011

Re: K111316 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: June 30, 2011 Received: July 05, 2011

Dear Mr. Seeger:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Marc Seegers, Dipl .- Ing.

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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

E.L. Keith

For 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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Indications for Use

K111316 510(k) Number (if known):

Device Name: aap Cannulated Screws 2.7-7.5

Indications for Use:

The aap Cannulated Screws are intended for use over a guide 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 reconstruction of fractures and joints
· adjuvant for osteosynthesis in complex joint fractures
· multifragment joint fractures
fractures of the femoral head and neck
supracondylar femoral fractures
· tibial plateau fractures
· simple metaphyseal fractures
simple epiphyseal fractures such as:
- fractures of the humeral head O
- fractures of the tibial plateau O
- pilon fractures ಿ
- fractures of the radius ം
fractures of the wrist, ankle, elbow, and shoulder
scaphoid fracture and other fractures of the hand
metatarsal fractures and other fractures of the foot
ligament fixation at the proximal humerus
acetabular fractures
fractures of the posterior pelvic ring
condylar fractures

റ

epiphyseal and metaphyseal fractures in children
ligament avulsion injuries
fractures of small joints, such as:
- ankle fractures o
  - navicular fractures
calcaneal and talar fractures
· arthrodesis of the ankle
avulsion fractures and fractures of metatarsal V
tarsal fractures

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

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)
	for M. Mellerm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K111316

510(k) Numb

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.