(71 days)
Not Found
No
The summary describes a mechanical device (cannulated screws) for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as cannulated screws intended for bone fracture fixation and bone fragment fixation, and they are mechanical implants used to stabilize bones, which falls under the category of orthopedic implants for surgical repair, not a therapeutic device in the sense of delivering therapy directly.
No
Explanation: The device is described as cannulated screws used for bone fracture and bone fragment fixation, and mechanical tests are mentioned. This indicates it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states the device is manufactured from Titanium Alloy and Stainless Steel, indicating it is a physical hardware device (screws).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the physical fixation of bone fractures and fragments. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details the materials and physical characteristics of screws, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for 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
Product codes
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 AG
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 30 750 19 0
Fax: +49 30 750 19 111 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | May 6, 2011 |
| Contact Person: | Marc Seegers, Dipl.-Ing.
Director QA/ RA
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 30 750 19 192
Fax: +49 30 750 19 111 |
| Proprietary Name: | aap Cannulated Screw |
| Common Name: | Cannulated Screw |
| Classification Name and Reference: | 21 CFR 888.3040 Smooth or threaded
metallic bone fixation fastener - Class II |
| Device Product Code and Panel Code: | Orthopedics/87/HWC |
1
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
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.
2
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.
3
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
4
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
5
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
- ankle fractures o
- 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